2. 筋萎縮性側索硬化症 Amyotrophic lateral sclerosis Clinical trials / Disease details
臨床試験数 : 645 / 薬物数 : 589 - (DrugBank : 163) / 標的遺伝子数 : 150 - 標的パスウェイ数 : 225
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT05395624 (ClinicalTrials.gov) | February 2, 2023 | 13/5/2022 | A Study to Evaluate the Safety, Pharmacokinetics and Biodistribution of an Imaging Agent, 18F-OP-801 (18F Hydroxyl Dendrimer) in Patients With Amyotrophic Lateral Sclerosis (ALS) and Healthy Volunteers (HV) | A Phase 1 Study to Evaluate the Safety, Pharmacokinetics and Biodistribution of an Imaging Agent, 18F-OP-801 (18F Hydroxyl Dendrimer), After Intravenous Administration to Patients With Amyotrophic Lateral Sclerosis (ALS) and Healthy Volunteers (HV) | Amyotrophic Lateral Sclerosis (ALS) | Drug: 18F-OP-801 | Ashvattha Therapeutics, Inc. | NULL | Recruiting | 18 Years | 80 Years | All | 26 | Phase 1 | United States |
| 2 | NCT05695521 (ClinicalTrials.gov) | January 30, 2023 | 3/1/2023 | Regulatory T Cells for Amyotrophic Lateral Sclerosis | Phase 1 Safety Run-in Study and Phase 1b Randomized, Double Blinded, Placebo Controlled Trial | Amyotrophic Lateral Sclerosis | Biological: CK0803;Other: Excipient | Cellenkos, Inc. | NULL | Not yet recruiting | 18 Years | 95 Years | All | 66 | Phase 1 | United States |
| 3 | NCT04505358 (ClinicalTrials.gov) | January 2023 | 23/7/2020 | Evaluate PU-AD in Subjects With Amyotrophic Lateral Sclerosis | A Randomized, Double-blind, Placebo-controlled Pilot Study to Evaluate the Biological Activity, Safety, and Pharmacokinetics of PU-AD in Subjects With Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis (ALS) | Drug: PU-AD;Drug: Placebo | Samus Therapeutics, Inc. | NULL | Withdrawn | 20 Years | 80 Years | All | 0 | Phase 2 | NULL |
| 4 | NCT05619783 (ClinicalTrials.gov) | December 29, 2022 | 27/10/2022 | Extension Study Evaluating The Safety And Tolerability of AMX0035 | A Phase IIIb, Open Label Extension Study Evaluating The Safety And Tolerability of AMX0035 Up To 108 Weeks In Adult Participants With Amyotrophic Lateral Sclerosis (ALS) Previously Enrolled In Study A35-004 (PHOENIX) | Amyotrophic Lateral Sclerosis | Drug: AMX0035 | Amylyx Pharmaceuticals Inc. | NULL | Enrolling by invitation | 18 Years | N/A | All | 600 | Phase 3 | Belgium;France;Germany;Ireland;Italy;Netherlands;Poland;Portugal;Spain;Sweden;United Kingdom |
| 5 | EUCTR2022-002348-33-ES (EUCTR) | 22/12/2022 | 27/09/2022 | A Phase IIIb, Open Label Extension Study Evaluating The Safety And Tolerability of AMX0035 Up To 108 Weeks In Adult Participants with Amyotrophic Lateral Sclerosis (ALS) Previously Enrolled In Study A35-004 (PHOENIX) | A Phase IIIb, Open Label Extension Study Evaluating The Safety And Tolerability of AMX0035 Up To 108 Weeks In Adult Participants with Amyotrophic Lateral Sclerosis (ALS) Previously Enrolled In Study A35-004 (PHOENIX) | ALS (amyotrophic lateral sclerosis) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: AMX0035 INN or Proposed INN: PHENYLBUTYRATE Other descriptive name: PHENYLBUTYRATE INN or Proposed INN: Ursodoxicoltaurine Other descriptive name: taurursodiol | Amylyx Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | Portugal;France;United States;Belgium;Poland;Spain;Ireland;Germany;Netherlands;United Kingdom;Italy;Sweden | ||
| 6 | NCT05633459 (ClinicalTrials.gov) | December 16, 2022 | 21/11/2022 | A Study Evaluating the Safety and Tolerability of QRL-201 in ALS | A Multi-Center, Randomized, Double-Blind Placebo Controlled Multiple-Ascending Dose Study to Evaluate the Safety and Tolerability of QRL-201 in Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis | Drug: QRL-201 - Dose 1;Drug: QRL-201 - Dose 2;Drug: QRL-201 - Dose 3;Drug: QRL-201 - Dose 4;Drug: QRL-201 - Dose 5;Drug: QRL-201 - Dose 6;Drug: QRL-201 - Dose 7;Drug: QRL-201- Dose 8 | QurAlis Corporation | NULL | Recruiting | 18 Years | 80 Years | All | 64 | Phase 1 | Canada |
| 7 | NCT05683860 (ClinicalTrials.gov) | December 14, 2022 | 4/1/2023 | Open-label Extension (OLE) Study of WVE-004 in Patients With C9orf72-associated Amyotrophic Lateral Sclerosis (ALS) and/or Frontotemporal Dementia (FTD) | A Multicenter, Open-label Extension (OLE) Study to Evaluate the Safety, Pharmacodynamics, and Clinical Effects of WVE-004 in Patients With C9orf72-associated Amyotrophic Lateral Sclerosis (ALS) and/or Frontotemporal Dementia (FTD) | ALS;FTD | Drug: WVE-004 | Wave Life Sciences Ltd. | NULL | Enrolling by invitation | N/A | N/A | All | 42 | Phase 1/Phase 2 | Netherlands |
| 8 | EUCTR2022-002348-33-NL (EUCTR) | 06/12/2022 | 11/10/2022 | A Phase IIIb, Open Label Extension Study Evaluating The Safety And Tolerability of AMX0035 Up To 108 Weeks In Adult Participants with Amyotrophic Lateral Sclerosis (ALS) Previously Enrolled In Study A35-0 | A Phase IIIb, Open Label Extension Study Evaluating The Safety And Tolerability of AMX0035 Up To 108 Weeks In Adult Participants with Amyotrophic Lateral Sclerosis (ALS) Previously Enrolled In Study A35-004 (PHOENIX) | ALS (amyotrophic lateral sclerosis) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: AMX0035 INN or Proposed INN: PHENYLBUTYRATE Other descriptive name: PHENYLBUTYRATE INN or Proposed INN: Ursodoxicoltaurine Other descriptive name: taurursodiol | Amylyx Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | Portugal;France;United States;Belgium;Spain;Poland;Ireland;Germany;Netherlands;United Kingdom;Italy;Sweden | ||
| 9 | NCT05189106 (ClinicalTrials.gov) | December 5, 2022 | 30/11/2021 | Neurodegenerative Alzheimer's Disease and Amyotrophic Lateral Sclerosis (NADALS) Basket Trial | Neurodegenerative Alzheimer's Disease and Amyotrophic Lateral Sclerosis (NADALS) Basket Proof of Concept Trial Including Asymptomatic Individuals Using Baricitinib | Amyotrophic Lateral Sclerosis;Alzheimer Disease;Mild Cognitive Impairment | Drug: Baricitinib | Massachusetts General Hospital | NULL | Recruiting | 18 Years | 90 Years | All | 20 | Phase 1/Phase 2 | United States |
| 10 | NCT05003921 (ClinicalTrials.gov) | December 2022 | 6/8/2021 | Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intrathecal Injection for ALS | Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intrathecal Injection for the Treatment of Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis | Biological: AlloRx | The Foundation for Orthopaedics and Regenerative Medicine | NULL | Suspended | N/A | N/A | All | 20 | Phase 1 | Antigua and Barbuda |
| 11 | NCT05597436 (ClinicalTrials.gov) | November 19, 2022 | 24/10/2022 | Intermediate-Sized Expanded Access Study | An Expanded Access Protocol of Intravenous Trehalose Injection 90.5 mg/mL Treatment of Patients With Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis | Drug: Trehalose | Seelos Therapeutics, Inc. | Massachusetts General Hospital;National Institute of Neurological Disorders and Stroke (NINDS);Office of the Director, National Institutes of Health (OD) | Temporarily not available | 18 Years | N/A | All | United States | ||
| 12 | NCT05407324 (ClinicalTrials.gov) | November 15, 2022 | 2/6/2022 | Dazucorilant in Patients With Amyotrophic Lateral Sclerosis | A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Safety and Efficacy of CORT113176 (Dazucorilant) in Patients With Amyotrophic Lateral Sclerosis (DAZALS) | Amyotrophic Lateral Sclerosis | Drug: Dazucorilant 300 mg;Drug: Dazucorilant 150 mg;Other: Placebo | Corcept Therapeutics | NULL | Recruiting | 18 Years | N/A | All | 198 | Phase 2 | Belgium;France;Netherlands;Poland |
| 13 | NCT05508074 (ClinicalTrials.gov) | November 2022 | 27/7/2022 | Treatment Combining Riluzole and IFB-088 in Bulbar Amyotrophic Lateral Sclerosis (TRIALS Protocol) | A Double-blind, Placebo-controlled, Exploratory Randomised Clinical Trial to Assess the Safety and Efficacy of IFB-088 Plus Riluzole 100 mg vs Placebo Plus Riluzole 100 mg in Patients With Bulbar-onset Amyotrophic Lateral Sclerosis. | Amyotrophic Lateral Sclerosis;ALS | Drug: IFB-088 50mg/day;Drug: Placebo;Drug: Riluzole 100mg/day | InFlectis BioScience | NULL | Recruiting | 18 Years | N/A | All | 50 | Phase 2 | France;Italy |
| 14 | NCT02988297 (ClinicalTrials.gov) | November 2022 | 7/12/2016 | Nebulized RNS60 for the Treatment of Amyotrophic Lateral Sclerosis | Nebulized RNS60 for the Treatment of Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis | Drug: RNS60;Drug: Placebo | Revalesio Corporation | NULL | Not yet recruiting | 18 Years | 80 Years | All | 140 | Phase 2 | NULL |
| 15 | NCT05568615 (ClinicalTrials.gov) | October 26, 2022 | 2/10/2022 | Extension Study Following the Studies MT-1186-A03 or A04 to Evaluate the Safety of Oral Edaravone in Subjects With ALS | Multicenter, Open-label Extension Study Following the Studies MT-1186-A03 or A04 to Evaluate the Safety of Oral Edaravone in Subjects With Amyotrophic Lateral Sclerosis (ALS) | ALS | Drug: MT-1186 | Mitsubishi Tanabe Pharma Corporation | NULL | Recruiting | 18 Years | N/A | All | 30 | Phase 3 | Japan |
| 16 | NCT04998305 (ClinicalTrials.gov) | September 30, 2022 | 21/7/2021 | TJ-68 Clinical Trial in Patients With Amyotrophic Lateral Sclerosis (ALS) and Muscle Cramps | A Phase 1/2 Two-center, Double-blind, Randomized, Placebo-controlled Multi-period Crossover (N-of-1) Study to Evaluable the Feasibility, Safety, and Efficacy of TJ-68 in Patients With Amyotrophic Lateral Sclerosis (ALS) and Muscle Cramps | Amyotrophic Lateral Sclerosis;Muscle Cramp | Drug: TJ-68;Drug: Placebo | Hiroshi Mitsumoto | Tsumura & Co., Tokyo, Japan | Recruiting | 20 Years | 70 Years | All | 26 | Phase 1/Phase 2 | United States |
| 17 | NCT05286372 (ClinicalTrials.gov) | September 23, 2022 | 9/3/2022 | An Intermediate Size Expanded Access Protocol of AMX0035 for ALS | An Intermediate Size, Expanded Access Protocol to Provide AMX0035, a Fixed Combination of Sodium Phenylbutyrate (PB) and Taurursodiol (TURSO), for the Treatment of Adult Patients With Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis | Drug: AMX0035 | Amylyx Pharmaceuticals Inc. | NULL | Approved for marketing | 18 Years | N/A | All | United States;Puerto Rico | ||
| 18 | NCT05370079 (ClinicalTrials.gov) | September 16, 2022 | 6/5/2022 | Control Cohort CTRL COH | Control Cohort CTRL COH | Parkinson's Disease; Amyotrophic Lateral Sclerosis; Glioblastoma; Cancer Without Neurological Disease; Rheumatoid Polyarthritis | Biological: Collection of biological sample (blood and/or CSF) | Hospices Civils de Lyon | NULL | Not yet recruiting | 18 Years | N/A | All | 350 | N/A | France |
| 19 | NCT05281484 (ClinicalTrials.gov) | August 31, 2022 | 7/3/2022 | Intermediate Expanded Access Protocol (EAP) CNMAu8.EAP02 | A Second Intermediate Expanded Access Protocol for Amyotrophic Lateral Sclerosis With CNM-Au8 | Amyotrophic Lateral Sclerosis | Drug: CNM-Au8 | Clene Nanomedicine | NULL | Available | 18 Years | N/A | All | United States | ||
| 20 | EUCTR2021-006511-29-DE (EUCTR) | 29/08/2022 | 13/06/2022 | A Phase 2 study of PTC587 in patients with Amyotrophic Lateral Sclerosis | A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL STUDY TO ASSESS THE EFFICACY, SAFETY, TOLERABILITY, PK, AND BIOMARKER EFFECTS OF PTC857 IN ADULT SUBJECTS WITH AMYOTROPHIC LATERAL SCLEROSIS (CARDINALS) - CARDINALS | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 20.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: PTC857 oral solution Product Code: PTC857 INN or Proposed INN: PTC857 Other descriptive name: PTC857 | PTC Therapeutics, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 258 | Phase 2 | United States;Czechia;Spain;Ireland;Italy;France;Mexico;Argentina;Belgium;Brazil;Poland;Australia;Norway;Germany;Netherlands;Japan;Korea, Republic of;Sweden | ||
| 21 | JPRN-jRCT2071220047 | 26/08/2022 | 27/08/2022 | Formulation Pharmacokinetics Study of EPI-589 | Formulation Pharmacokinetics Study of EPI-589 (DA350102) | Amyotrophic lateral sclerosis | Subjects receive a test formulation (containing 1000 mg of EPI-589) or a reference formulation (containing 1000 mg of EPI-589) once orally in period 1 and period 2. | Hamatani Tatsuto | NULL | Recruiting | >= 20age old | < 55age old | Male | 24 | Phase 1 | Japan |
| 22 | NCT05542576 (ClinicalTrials.gov) | August 24, 2022 | 7/9/2022 | AMDX-2011P Retinal Tracer in Subjects With Neurodegenerative Diseases Associated With Amyloidogenic Proteinopathy | Prospective Randomized Open, Blinded Endpoint (PROBE) Study of AMDX-2011P as a Retinal Tracer in Subjects With Neurodegenerative Diseases Associated With Amyloidogenic Proteinopathy | Parkinson Disease;Amyotrophic Lateral Sclerosis | Drug: AMDX2011P | Amydis Inc. | NULL | Recruiting | 18 Years | N/A | All | 36 | Phase 1/Phase 2 | United States |
| 23 | NCT05442775 (ClinicalTrials.gov) | July 25, 2022 | 16/6/2022 | A Phase 3, Open-Label Extension of COURAGE-ALS (CY 5031) | A Phase 3, Open-Label Extension of COURAGE-ALS (CY 5031) | Amyotrophic Lateral Sclerosis | Drug: Reldesemtiv | Cytokinetics | NULL | Recruiting | 18 Years | N/A | All | 400 | Phase 3 | United States;Australia;Belgium;Canada;Italy;Netherlands;Spain |
| 24 | EUCTR2021-003900-42-DE (EUCTR) | 15/07/2022 | 17/03/2022 | Continued Efficacy and Safety Study of Oral Edaravone Following Study MT-1186-A02 in Subjects with Amyotrophic Lateral Sclerosis (ALS) | A Phase 3b, Multicenter, Randomized, Double-blind Extension Study to Evaluate the Continued Efficacy and Safety of Oral Edaravone Administered for an Additional Period of up to 48 Weeks Following Study MT-1186-A02 in Subjects with Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Edaravone Product Code: MT-1186 INN or Proposed INN: EDARAVONE | Mitsubishi Tanabe Pharma Development America, Inc. (MTDA) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | United States;Canada;Germany;Italy;Switzerland;Japan;Korea, Republic of | ||
| 25 | NCT05357950 (ClinicalTrials.gov) | May 31, 2022 | 27/4/2022 | A Phase IIb, Multi-Center, Multinational, Double-Blind, Placebo-Controlled Study, With an Open Label Extension, to Evaluate Safety, Tolerability and Efficacy of PrimeC in Subjects With ALS | A Phase IIb, Randomized, Multi-Center, Multinational, Prospective, Double-Blind, Placebo-Controlled Study, With an Open Label Extension, to Evaluate Safety, Tolerability and Efficacy of PrimeC in Subjects With ALS | Amyotrophic Lateral Sclerosis;ALS | Drug: PrimeC;Drug: Placebo | NeuroSense Therapeutics Ltd. | NULL | Recruiting | 18 Years | 75 Years | All | 69 | Phase 2 | Israel;United States |
| 26 | NCT05349721 (ClinicalTrials.gov) | May 15, 2022 | 21/4/2022 | Study to Assess the Effects of PTC857 Treatment in Participants With Amyotrophic Lateral Sclerosis ALS | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Assess the Efficacy, Safety, Tolerability, PK, and Biomarker Effects of PTC857 in Adult Subjects With Amyotrophic Lateral Sclerosis (CARDINALS) | Amyotrophic Lateral Sclerosis | Drug: PTC857;Drug: Placebo | PTC Therapeutics | NULL | Recruiting | 18 Years | 80 Years | All | 258 | Phase 2 | United States |
| 27 | NCT05306457 (ClinicalTrials.gov) | May 8, 2022 | 21/12/2021 | CNS10-NPC-GDNF Delivered to the Motor Cortex for ALS | Human Neural Progenitor Cells Secreting Glial Cell Line-Derived Neurotrophic Factor (CNS10-NPC-GDNF) Delivered to the Motor Cortex for the Treatment of Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis | Biological: CNS10-NPC-GDNF | Cedars-Sinai Medical Center | California Institute for Regenerative Medicine (CIRM) | Recruiting | 18 Years | N/A | All | 16 | Phase 1 | United States |
| 28 | ChiCTR2200058224 | 2022-05-01 | 2022-04-03 | The treatment of primidone for bulbar dysfunction in amyotrophic lateral sclerosis: A randomized, double-blind, cross-over controlled clinical trial | The treatment of primidone for bulbar dysfunction in amyotrophic lateral sclerosis: A randomized, double-blind, cross-over controlled clinical trial | amyotrophic lateral sclerosis | Group A:phase I: primidone 60 mg/d; Wash-out period: no intervention; phase II: placebo control;Group B:phase I: placebo control; Wash-out period: no intervention; phase II: primidone 60 mg/d; | The First People's Hospital of Yichang | NULL | Pending | 18 | Both | Group A:50;Group B:50; | Phase 2 | China | |
| 29 | EUCTR2021-000250-26-PT (EUCTR) | 29/04/2022 | 08/10/2021 | A study to investigate the safety and efficacy of AMX0035 in patients with Amyotrophic Lateral Sclerosis | A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of AMX0035 Versus Placebo for 48-week Treatment of Adult Patients with Amyotrophic Lateral Sclerosis (ALS) - Phoenix | ALS (amyotrophic lateral sclerosis) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: AMX0035 INN or Proposed INN: phenylbutyrate INN or Proposed INN: Ursodoxicoltaurine Other descriptive name: taurursodiol Product Code: AMX0035 INN or Proposed INN: PHENYLBUTYRATE INN or Proposed INN: Ursodoxicoltaurine Other descriptive name: taurursodiol | Amylyx Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | France;United States;Portugal;Spain;Poland;Belgium;Ireland;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 30 | NCT05237284 (ClinicalTrials.gov) | April 13, 2022 | 2/2/2022 | Phase 2 Study for SAR443820 in Participants With Amyotrophic Lateral Sclerosis (ALS) | A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of SAR443820 in Adult Participants With Amyotrophic Lateral Sclerosis, Followed by an Open-label Extension | Amyotrophic Lateral Sclerosis | Drug: SAR443820;Drug: Placebo | Sanofi | NULL | Recruiting | 18 Years | 80 Years | All | 261 | Phase 2 | United States;Belgium;Canada;China;France;Germany;Italy;Japan;Netherlands;Spain;Sweden;United Kingdom |
| 31 | EUCTR2021-004156-42-SE (EUCTR) | 12/04/2022 | 13/12/2021 | Phase 2 study for SAR443820 in participants with amyotrophic lateral sclerosis (ALS) | A Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of SAR443820 in adult participants withamyotrophic lateral sclerosis, followed by an open-label extension | Amyotrophic lateral sclerosis MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: SAR443820 Other descriptive name: RA15804589, C19061501-F, DNL788, DN2489, DN0002489 | Sanofi-aventis recherche & développement | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 261 | Phase 2 | France;United States;Canada;Belgium;Spain;Germany;Netherlands;United Kingdom;Italy;Japan;China;Sweden | ||
| 32 | EUCTR2020-000579-19-ES (EUCTR) | 04/04/2022 | 02/11/2021 | An international multi-center clinical trial to investigate the efficacy of multiple drug compounds in patients with Amyotrophic Lateral Sclrerosis (ALS). | A Multi-arm, Adaptive, Group-sequential trial NETwork to evaluate drug efficacy in patients with Amyotrophic Lateral Sclerosis (ALS) - MAGNET | Amyotrophic Lateral Sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Lithium Carbonate INN or Proposed INN: Lithium carbonate Other descriptive name: LITHIUM CARBONATE | Stichting TRICALS Foundation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 171 | Phase 3 | Belgium;Spain;Ireland;Australia;Netherlands;United Kingdom;Sweden | ||
| 33 | JPRN-jRCT2051220002 | 03/04/2022 | 08/04/2022 | Phase 1/2 Study of Bosutinib in Patients with Amyotrophic Lateral Sclerosis (ALS) | Phase 1/2 Study of Bosutinib in Patients with Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis (ALS) | Patients will receive bosutinib once daily, orally, for 24 weeks | Inoue Haruhisa | NULL | Recruiting | >= 20age old | <= 75age old | Both | 25 | Phase 2 | Japan |
| 34 | NCT04820478 (ClinicalTrials.gov) | April 1, 2022 | 24/3/2021 | Efficacy and Tolerability of Beta Hydroxybutyrate Ester in Patients With Amyotrophic Lateral Sclerosis (ALS) | Efficacy and Tolerability of Beta Hydroxybutyrate Ester in Patients With Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis | Dietary Supplement: Beta Hydroxybutyrate Ester;Dietary Supplement: Placebo | University of Ulm | NULL | Recruiting | 18 Years | N/A | All | 76 | N/A | Germany |
| 35 | NCT04972487 (ClinicalTrials.gov) | March 29, 2022 | 15/7/2021 | Expanded Access Program for Tofersen in Participants With Superoxide Dismutase 1-Amyotropic Lateral Sclerosis | Global Early Access Program to Provide Tofersen To Patients With Amyotrophic Lateral Sclerosis (ALS) Associated With a Mutation in the Superoxide Dismutase 1 (SOD1) Gene | Superoxide Dismutase 1-Amyotropic Lateral Sclerosis | Drug: Tofersen | Biogen | NULL | Available | 18 Years | N/A | All | United States | ||
| 36 | EUCTR2021-004156-42-FR (EUCTR) | 23/03/2022 | 20/01/2022 | Phase 2 study for SAR443820 in participants with amyotrophic lateral sclerosis (ALS) | A Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of SAR443820 in adult participants withamyotrophic lateral sclerosis, followed by an open-label extension | Amyotrophic lateral sclerosis MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: SAR443820 Other descriptive name: RA15804589, C19061501-F, DNL788, DN2489, DN0002489 | Sanofi-aventis recherche & développement | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 261 | Phase 2 | United States;France;Canada;Spain;Belgium;Netherlands;Germany;United Kingdom;Japan;Italy;China;Sweden | ||
| 37 | EUCTR2021-004156-42-NL (EUCTR) | 10/03/2022 | 21/12/2021 | Phase 2 study for SAR443820 in participants with amyotrophic lateral sclerosis (ALS) | A Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of SAR443820 in adult participants withamyotrophic lateral sclerosis, followed by an open-label extension | Amyotrophic lateral sclerosis MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: SAR443820 INN or Proposed INN: - Other descriptive name: RA15804589, C19061501-F, DNL788, DN2489, DN0002489 | Sanofi-aventis recherche & développement | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 261 | Phase 2 | France;United States;Canada;Spain;Belgium;Germany;Netherlands;United Kingdom;Japan;Italy;China;Sweden | ||
| 38 | EUCTR2021-004156-42-ES (EUCTR) | 08/03/2022 | 30/12/2021 | Phase 2 study for SAR443820 in participants with amyotrophic lateral sclerosis (ALS) | A Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of SAR443820 in adult participants with amyotrophic lateral sclerosis, followed by an open-label extension | Amyotrophic lateral sclerosis MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: SAR443820 INN or Proposed INN: SAR443820 Other descriptive name: RA15804589, C19061501-F, DNL788, DN2489, DN0002489 | Sanofi-aventis recherche & développement | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 261 | Phase 2 | France;United States;Canada;Belgium;Spain;Netherlands;Germany;United Kingdom;Japan;Italy;China;Sweden | ||
| 39 | NCT05193994 (ClinicalTrials.gov) | February 24, 2022 | 6/12/2021 | Triumeq in Amyotrophic Lateral Sclerosis | Randomised Double-Blind Placebo-Controlled Phase 3 Trial of Triumeq in Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis | Drug: Dolutegravir, Abacavir and Lamivudine;Drug: Placebo | Macquarie University, Australia | King's College London;Stichting TRICALS Foundation | Recruiting | 18 Years | N/A | All | 390 | Phase 3 | Australia |
| 40 | JPRN-jRCT2071210117 | 23/02/2022 | 21/01/2022 | Efficacy and Safety Extension Study of Oral Edaravone Administered in Subjects With ALS | A Phase 3b, Multicenter, Randomized, Double-blind Extension Study to Evaluate the Continued Efficacy and Safety of Oral Edaravone Administered for an Additional Period of up to 48 Weeks Following Study MT-1186-A02 in subjects with Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis | - Oral edaravone administered once daily for up to 48 weeks or until the drug is commercially available in that country - Oral edaravone administered for 10 days followed by 18-day placebo (regimen denoted as on/off) for up to 48 weeks or until the drug is commercially available in that country | Kondo Kazuoki | NULL | Recruiting | >= 18age old | Not applicable | Both | 300 | Phase 3 | US;Canada;Germany;Italia;South Korea;Switzerland;Japan |
| 41 | EUCTR2020-003376-40-SE (EUCTR) | 23/02/2022 | 29/12/2021 | A study to investigate the efficacy and safety of FAB122 in patients with Amyotrophic Lateral Sclerosis | A multicenter, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of FAB122 in patients with Amyotrophic Lateral Sclerosis - ADORE | Amyotrophic Lateral Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Edaravone Product Code: FAB122 INN or Proposed INN: EDARAVONE | Ferrer Internacional, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | France;Portugal;Spain;Poland;Belgium;Ireland;Russian Federation;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 42 | EUCTR2021-004156-42-BE (EUCTR) | 23/02/2022 | 22/12/2021 | Phase 2 study for SAR443820 in participants with amyotrophic lateral sclerosis (ALS) | A Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of SAR443820 in adult participants withamyotrophic lateral sclerosis, followed by an open-label extension | Amyotrophic lateral sclerosis MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: SAR443820 Other descriptive name: RA15804589, C19061501-F, DNL788, DN2489, DN0002489 | Sanofi-aventis recherche & développement | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 261 | Phase 2 | United States;Spain;Italy;United Kingdom;France;Canada;Belgium;Poland;Netherlands;Germany;China;Japan;Sweden | ||
| 43 | EUCTR2021-000250-26-PL (EUCTR) | 23/02/2022 | 22/11/2021 | A study to investigate the safety and efficacy of AMX0035 in patients with Amyotrophic Lateral Sclerosis | A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of AMX0035 Versus Placebo for 48-week Treatment of Adult Patients with Amyotrophic Lateral Sclerosis (ALS) - Phoenix | ALS (amyotrophic lateral sclerosis) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: AMX0035 INN or Proposed INN: phenylbutyrate INN or Proposed INN: Ursodoxicoltaurine Other descriptive name: taurursodiol | Amylyx Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | Portugal;France;United States;Belgium;Spain;Poland;Ireland;Germany;Netherlands;United Kingdom;Italy;Sweden | ||
| 44 | NCT05136885 (ClinicalTrials.gov) | February 21, 2022 | 14/11/2021 | HEALEY ALS Platform Trial - Regimen E SLS-005 - Trehalose | HEALEY ALS Platform Trial - Regimen E SLS-005 - Trehalose | Amyotrophic Lateral Sclerosis | Drug: SLS-005;Drug: Matching Placebo | Merit E. Cudkowicz, MD | Seelos Therapeutics, Inc. | Enrolling by invitation | 18 Years | N/A | All | 160 | Phase 2/Phase 3 | United States |
| 45 | EUCTR2019-001862-13-PT (EUCTR) | 18/02/2022 | 21/05/2020 | Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS) | A prospective, multicenter, randomised, double-blind, placebo-controlled, parallel groups, phase 3 study to compare the efficacy and safety of masitinib in combination with Riluzole versus placebo in combination with Riluzole in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - not applicable | patients suffering from Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: na Product Name: masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: na | ABScience | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 495 | Phase 3 | United States;Portugal;Slovenia;Greece;Spain;Ireland;Israel;Russian Federation;United Kingdom;Italy;France;Canada;Argentina;Belgium;Poland;Denmark;Norway;Germany;Netherlands;Sweden | ||
| 46 | EUCTR2021-003875-32-IT (EUCTR) | 15/02/2022 | 29/12/2021 | Clinical trial to assess the safety and efficacy of IFB-088 plus riluzole 100 mg vs placebo plus riluzole 100 mg in patients with bulbar-onset amyotrophic lateral sclerosis | A double-blind, placebo-controlled, exploratory randomised clinical trial to assess the safety and efficacy of IFB-088 plus riluzole 100 mg vs placebo plus riluzole 100 mg in patients with bulbar-onset amyotrophic lateral sclerosis (Study TRIALS) - TRIALS | Amyotrophic lateral sclerosis (bulbar-onset) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Icerguastat Product Code: [IFB-088] | InFlectis BioScience | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 50 | Phase 2 | France;Italy | ||
| 47 | EUCTR2019-001862-13-GR (EUCTR) | 03/02/2022 | 26/11/2021 | Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS) | A prospective, multicenter, randomised, double-blind, placebo-controlled, parallel groups, phase 3 study to compare the efficacy and safety of masitinib in combination with Riluzole versus placebo in combination with Riluzole in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - Amyotrophic Lateral Sclerosis (ALS) | patients suffering from Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: na Product Name: masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: na | AB Science | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 495 | Phase 3 | United States;Portugal;Slovenia;Greece;Spain;Ukraine;Ireland;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Canada;Argentina;Belgium;Poland;Denmark;Norway;Germany;Netherlands;Sweden | ||
| 48 | EUCTR2021-002251-11-ES (EUCTR) | 31/01/2022 | 08/10/2021 | A clinical study to learn whether a new drug, TPN-101, is safe when given to patients with amyotrophic lateral sclerosis or frontotemporal dementia due to a genetic mutation called C9orf72 hexanucleotide repeat expansion. | A Phase 2a Study of TPN-101 in Patients with C9ORF72 ALS/FTD (Amyotrophic Lateral Sclerosis and/or Frontotemporal Dementia) | Amyotrophic lateral sclerosis or frontotemporal dementia due to a genetic mutation called C9orf72 hexanucleotide repeat expansion MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: TPN-101 Product Code: TPN-101 INN or Proposed INN: CENSAVUDINE | Transposon Therapeutics, Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 2 | France;United States;Canada;Belgium;Spain;Netherlands;Germany;United Kingdom | ||
| 49 | EUCTR2020-005193-94-SE (EUCTR) | 26/01/2022 | 12/10/2021 | Phase 1b/2a Study of WVE-004 in Patients with C9orf72-associated Amyotrophic Lateral Sclerosis (ALS) or Frontotemporal Dementia (FTD) | A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 1b/2a Study of WVE-004 Administered Intrathecally to Patients with C9orf72-associated Amyotrophic Lateral Sclerosis (ALS) or Frontotemporal Dementia (FTD) | Amyotrophic Lateral Sclerosis and Frontotemporal Dementia MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: WVE-004 INN or Proposed INN: not yet assigned Other descriptive name: Synthetic stereopure antisense oligonucleotide targeting human C9orf72 hexanucleotide repeat-containing mRNA transcripts | Wave Life Sciences UK Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 42 | Phase 1;Phase 2 | United States;Canada;Belgium;Ireland;Australia;Netherlands;Germany;United Kingdom;New Zealand;Sweden | ||
| 50 | EUCTR2020-005193-94-BE (EUCTR) | 26/01/2022 | 15/10/2021 | Phase 1b/2a Study of WVE-004 in Patients with C9orf72-associated Amyotrophic Lateral Sclerosis (ALS) or Frontotemporal Dementia (FTD) | A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 1b/2a Study of WVE-004 Administered Intrathecally to Patients with C9orf72-associated Amyotrophic Lateral Sclerosis (ALS) or Frontotemporal Dementia (FTD) | Amyotrophic Lateral Sclerosis and Frontotemporal Dementia MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: WVE-004 INN or Proposed INN: not yet assigned Other descriptive name: Synthetic stereopure antisense oligonucleotide targeting human C9orf72 hexanucleotide repeat-containing mRNA transcripts | Wave Life Sciences UK Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 42 | Phase 1;Phase 2 | United States;Canada;Belgium;Ireland;Australia;Netherlands;Germany;United Kingdom;New Zealand;Sweden | ||
| 51 | EUCTR2020-004590-51-IT (EUCTR) | 24/01/2022 | 07/06/2021 | A Study of BIIB067 When Initiated in Clinically Presymptomatic Adults With a Confirmed Superoxide Dismutase 1 Mutation | A Phase 3 Randomized, Placebo-Controlled Trial With a Longitudinal Natural History Run-In and Open-Label Extension to Evaluate BIIB067 Initiated in Clinically Presymptomatic Adults With a Confirmed Superoxide Dismutase 1 Mutation - ATLAS | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 20.0;Level: PT;Classification code 10077024;Term: Familial amyotrophic lateral sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 21.1;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10052653;Term: Amyotrophic lateral sclerosis gene carrier;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: nd Product Code: [BIIB067 (ISIS666853)] INN or Proposed INN: tofersen Other descriptive name: BIIB067 | BIOGEN IDEC RESEARCH LIMITED | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | United States;Spain;Russian Federation;United Kingdom;Italy;France;Canada;Brazil;Belgium;Poland;Australia;Bulgaria;Germany;Japan;Sweden;Korea, Republic of | ||
| 52 | EUCTR2020-004040-29-PT (EUCTR) | 14/01/2022 | 20/05/2021 | A Clinical Study in which patients diagnosed with Amyotrophic Lateral Sclerosis (ALS) will receive Reldesemtiv (study drug). The safety and efficacy of the drug will be tested. | A Phase 3, Multi-center, Double Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Reldesemtiv in Patients with Amyotrophic Lateral Sclerosis (ALS). - COURAGE-ALS | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: reldesemtiv Product Code: CK-2127107 INN or Proposed INN: reldesemtiv Other descriptive name: RELDESEMTIV | Cytokinetics Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 555 | Phase 3 | Portugal;United States;Spain;Ireland;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Poland;Australia;Germany;Netherlands;Sweden | ||
| 53 | NCT05151471 (ClinicalTrials.gov) | January 11, 2022 | 28/11/2021 | Efficacy and Safety Extension Study of Oral Edaravone Administered in Subjects With ALS | A Phase 3b, Multicenter, Randomized, Double-blind Extension Study to Evaluate the Continued Efficacy and Safety of Oral Edaravone Administered for an Additional Period of up to 48 Weeks Following Study MT-1186-A02 in Subjects With Amyotrophic Lateral Sclerosis (ALS) | ALS | Drug: MT-1186;Drug: Placebo | Mitsubishi Tanabe Pharma Development America, Inc. | NULL | Recruiting | 18 Years | N/A | All | 300 | Phase 3 | United States;Canada;Germany;Japan;Korea, Republic of;Switzerland;United Kingdom |
| 54 | ChiCTR2100051913 | 2021-12-31 | 2021-10-09 | Sodium Phenylbutyrate Granules Combined with Tauroursodeoxycholic Acid Capsules for Amyotrophic Lateral Sclerosis: A Multicentre, Randomised, Double-blind, Placebo-controlled Clinical Trial | Sodium Phenylbutyrate Granules Combined with Tauroursodeoxycholic Acid Capsules for Amyotrophic Lateral Sclerosis: A Multicentre, Randomised, Double-blind, Placebo-controlled Clinical Trial | Amyotrophic lateral sclerosis | Experimental group:Sodium phenylbutyrate granules + tauroursodeoxycholic acid capsules;Control group:Sodium phenylbutyrate placebo + tauroursodeoxycholic acid placebo; | Peking Union Medical College Hospital, Chinese Academy of Medical Sciences | NULL | Pending | 18 | 80 | Both | Experimental group:136;Control group:68; | N/A | China |
| 55 | NCT05218668 (ClinicalTrials.gov) | December 22, 2021 | 23/11/2021 | Rho Kinase Inhibitor in Amyotrophic Lateral Sclerosis (REAL) | A Phase 2a Open-Label Preliminary Safety, Efficacy, and Biomarker Study of WP-0512 in Patients With Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis | Drug: Fasudil (WP-0512) | Woolsey Pharmaceuticals | NULL | Active, not recruiting | 18 Years | 75 Years | All | 30 | Phase 2 | United States;Australia |
| 56 | EUCTR2020-005971-11-DE (EUCTR) | 22/12/2021 | 11/06/2021 | A Phase 2a study to evaluate, safety, tolerability, pharmacodynamic markers, and pharmacokinetics of AP-101 in patients with amyotrophic lateral sclerosis (ALS) | A Phase 2a, multicenter, randomized, double-blind, placebo-controlled study to evaluate safety, tolerability, pharmacodynamic markers, and pharmacokinetics of AP-101 in patients with familial amyotrophic lateral sclerosis (fALS) and sporadic amyotrophic lateral sclerosis (sALS) | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: AP-101 Product Code: AP-101 INN or Proposed INN: Not yet available Other descriptive name: Anti-(misfolded human superoxide dismutase 1) human IgG1m3 monoclonal antibody | AL-S Pharma, AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 63 | Phase 2 | United States;Canada;Germany;Sweden;Korea, Republic of | ||
| 57 | EUCTR2021-000250-26-IT (EUCTR) | 14/12/2021 | 18/10/2021 | A study to investigate the safety and efficacy of AMX0035 in patients with Amyotrophic Lateral Sclerosis | A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of AMX0035 Versus Placebo for 48-week Treatment of Adult Patients with Amyotrophic Lateral Sclerosis (ALS) - Phoenix | ALS (amyotrophic lateral sclerosis);Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: AMX0035 Product Code: [AMX0035] INN or Proposed INN: Sodio phenylbutyrate INN or Proposed INN: Tauroursodeoxycholic Acid | AMYLYX PHARMACEUTICALS Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | Portugal;France;United States;Spain;Poland;Belgium;Ireland;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 58 | EUCTR2021-002251-11-DE (EUCTR) | 06/12/2021 | 02/08/2021 | A clinical study to learn whether a new drug, TPN-101, is safe when given to patients with amyotrophic lateral sclerosis or frontotemporal dementia due to a genetic mutation called C9orf72 hexanucleotide repeat expansion. | A Phase 2a Study of TPN-101 in Patients with C9ORF72 ALS/FTD (Amyotrophic Lateral Sclerosis and/or Frontotemporal Dementia) | Amyotrophic lateral sclerosis or frontotemporal dementia due to a genetic mutation called C9orf72 hexanucleotide repeat expansion MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: TPN-101 Product Code: TPN-101 INN or Proposed INN: CENSAVUDINE | Transposon Therapeutics, Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 2 | France;United States;Canada;Spain;Belgium;Netherlands;Germany;United Kingdom | ||
| 59 | NCT02478450 (ClinicalTrials.gov) | December 2021 | 11/6/2015 | Study to Investigate the Safety of the Transplantation (by Injection) of Human Glial Restricted Progenitor Cells (hGRPs; Q-Cells®) Into Subjects With Amyotrophic Lateral Sclerosis (ALS) | A Phase 1/2a Open-Label Study to Investigate the Safety of the Transplantation (by Injection) of Human Glial Restricted Progenitor Cells (hGRPs; Q-Cells®) Into Subjects With Amyotrophic Lateral Sclerosis (ALS): Assessment of Localized Therapeutic Activity by Blinded Observation and Lateral Transplantation (ALTA-BOLT) | Amyotrophic Lateral Sclerosis | Biological: Q-Cells | Q Therapeutics, Inc. | NULL | Not yet recruiting | 18 Years | N/A | All | 30 | Phase 1/Phase 2 | NULL |
| 60 | NCT05039268 (ClinicalTrials.gov) | November 25, 2021 | 23/8/2021 | 3K3A-APC for Treatment of Amyotrophic Lateral Sclerosis (ALS) | A Phase 2 Open Label Trial of 3K3A-APC in Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis | Drug: 3K3A-APC Protein | Macquarie University, Australia | ZZ Biotech, LLC | Completed | 18 Years | 75 Years | All | 16 | Phase 2 | Australia |
| 61 | EUCTR2020-004040-29-NL (EUCTR) | 25/11/2021 | 01/09/2021 | A Clinical Study in which patients diagnosed with Amyotrophic Lateral Sclerosis (ALS) will receive Reldesemtiv (study drug). The safety and efficacy of the drug will be tested. | A Phase 3, Multi-center, Double Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Reldesemtiv in Patients with Amyotrophic Lateral Sclerosis (ALS). - COURAGE-ALS | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: reldesemtiv Product Code: CK-2127107 INN or Proposed INN: reldesemtiv Other descriptive name: RELDESEMTIV | Cytokinetics Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 555 | Phase 3 | United States;Portugal;Spain;Ireland;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Poland;Australia;Netherlands;Germany;Sweden | ||
| 62 | EUCTR2021-000250-26-FR (EUCTR) | 22/11/2021 | 25/06/2021 | A study to investigate the safety and efficacy of AMX0035 in patients with Amyotrophic Lateral Sclerosis | A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of AMX0035 Versus Placebo for 48-week Treatment of Adult Patients with Amyotrophic Lateral Sclerosis (ALS) - Phoenix | ALS (amyotrophic lateral sclerosis) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: AMX0035 INN or Proposed INN: phenylbutyrate INN or Proposed INN: Ursodoxicoltaurine Other descriptive name: taurursodiol Product Code: AMX0035 INN or Proposed INN: PHENYLBUTYRATE INN or Proposed INN: Ursodoxicoltaurine Other descriptive name: taurursodiol | Amylyx Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | Portugal;United States;France;Spain;Poland;Belgium;Ireland;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 63 | NCT04654689 (ClinicalTrials.gov) | November 20, 2021 | 13/11/2020 | Impact of the Combined Treatment of Liposomed Polyphenols With G04CB02 on the ALS Patients | Impact of the Combined Treatment of Curcumin and Resveratrol Liposomed Polyphenols With G04CB02 on the Clinical Improvement of ALS Patients | Amyotrophic Lateral Sclerosis | Dietary Supplement: Liposomed polyphenols resveratrol and curcumin;Other: Placebo for liposomed resveratrol and curcumin;Dietary Supplement: Isocaloric Diet;Drug: G04CB02;Other: Placebo microcrystalline methylcellulose | Fundación Universidad Católica de Valencia San Vicente Mártir | NULL | Active, not recruiting | 18 Years | 75 Years | All | 90 | Phase 2 | Spain |
| 64 | NCT05176093 (ClinicalTrials.gov) | November 14, 2021 | 5/11/2021 | A 6-Month Extension Study to Assess the Long-Term Safety of Engensis in Amyotrophic Lateral Sclerosis | A 6-Month Extension Study Following Protocol VMALS-002-2 (A Phase 2a, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Safety of Engensis in Participants With Amyotrophic Lateral Sclerosis) | Amyotrophic Lateral Sclerosis | Biological: Engensis;Other: Placebo | Helixmith Co., Ltd. | NULL | Completed | 18 Years | 80 Years | All | 8 | Phase 2 | United States;Korea, Republic of |
| 65 | NCT05299658 (ClinicalTrials.gov) | November 13, 2021 | 8/3/2022 | An Open-Label Extension for the Phase 2 Study in Early Symptomatic Amyotrophic Lateral Sclerosis Patients on Stable Background Therapy to Assess Bioenergetic Catalysis With CNM-Au8 to Slow Disease Progression in ALS | An Open-Label Extension for the Phase 2, Randomised, Double-Blind, Placebo-Controlled Study in Early Symptomatic Amyotrophic Lateral Sclerosis Patients on Stable Background Therapy to Assess Bioenergetic Catalysis With CNM-Au8 to Slow Disease Progression in ALS | Amyotrophic Lateral Sclerosis | Drug: CNMAu8 | Clene Nanomedicine | NULL | Active, not recruiting | 30 Years | 80 Years | All | 40 | Phase 2 | Australia |
| 66 | NCT05021536 (ClinicalTrials.gov) | October 28, 2021 | 20/8/2021 | Phase III Trial of AMX0035 for Amyotrophic Lateral Sclerosis Treatment | A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of AMX0035 Versus Placebo for 48-week Treatment of Adult Patients With Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis | Other: Placebo;Drug: AMX0035 | Amylyx Pharmaceuticals Inc. | NULL | Active, not recruiting | 18 Years | N/A | All | 600 | Phase 3 | United States;Belgium;France;Germany;Ireland;Italy;Netherlands;Poland;Portugal;Spain;Sweden;United Kingdom;Puerto Rico |
| 67 | EUCTR2021-000250-26-DE (EUCTR) | 27/10/2021 | 22/06/2021 | A study to investigate the safety and efficacy of AMX0035 in patients with Amyotrophic Lateral Sclerosis | A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of AMX0035 Versus Placebo for 48-week Treatment of Adult Patients with Amyotrophic Lateral Sclerosis (ALS) - Phoenix | ALS (amyotrophic lateral sclerosis) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: AMX0035 INN or Proposed INN: phenylbutyrate INN or Proposed INN: Ursodoxicoltaurine Other descriptive name: taurursodiol | Amylyx Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | Portugal;France;United States;Spain;Poland;Belgium;Ireland;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 68 | EUCTR2020-003376-40-DE (EUCTR) | 26/10/2021 | 16/06/2021 | A multicenter, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of FAB122 in patients with Amyotrophic Lateral Sclerosis | A multicenter, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of FAB122 in patients with Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Edaravone Product Code: FAB122 INN or Proposed INN: EDARAVONE | Ferrer Internacional, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | France;Portugal;Spain;Poland;Belgium;Ireland;Russian Federation;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 69 | NCT05753852 (ClinicalTrials.gov) | October 25, 2021 | 23/2/2023 | Open Label Extension of TUDCA-ALS Study | Open Label Extension Study to Investigate Long Term Safety, Tolerability and Efficacy of Tauroursodeoxycholic Acid in Patients With ALS Who Completed the TUDCA-ALS Study | Amyotrophic Lateral Sclerosis | Drug: Tauroursodeoxycholic Acid | Humanitas Mirasole SpA | University of Ulm;University of Sheffield;University Hospital, Tours;KU Leuven;UMC Utrecht;University of Dublin, Trinity College;Bruschettini S.r.l.;Istituto Superiore di Sanità;Motor Neurone Disease Association | Recruiting | 18 Years | N/A | All | 184 | Phase 3 | Belgium;France;Germany;Ireland;Italy;Netherlands;United Kingdom |
| 70 | NCT05031351 (ClinicalTrials.gov) | October 19, 2021 | 5/8/2021 | NF-?B Inhibition in Amyotrophic Lateral Sclerosis | Nuclear Factor Kappa Beta Inhibition in Patients With Amyotrophic Lateral Sclerosis: A Phase II Randomized Placebo Controlled Trial | ALS | Drug: Withania somnifera;Drug: Placebo | Sunnybrook Health Sciences Centre | NULL | Recruiting | 18 Years | N/A | All | 75 | Phase 2 | Canada |
| 71 | NCT05178810 (ClinicalTrials.gov) | October 18, 2021 | 16/12/2021 | Study to Investigate the Efficacy and Safety of FAB122 (Daily Oral Edaravone) in Patients With Amyotrophic Lateral Sclerosis | A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of FAB122 in Patients With Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis | Drug: FAB122;Drug: Placebo | Ferrer Internacional S.A. | Julius Clinical;Stichting TRICALS Foundation | Active, not recruiting | 18 Years | 80 Years | All | 300 | Phase 3 | Belgium;France;Germany;Ireland;Italy;Netherlands;Poland;Portugal;Spain;Sweden;United Kingdom |
| 72 | EUCTR2020-003376-40-IE (EUCTR) | 12/10/2021 | 10/06/2021 | A study to investigate the efficacy and safety of FAB122 in patients with Amyotrophic Lateral Sclerosis | A multicenter, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of FAB122 in patients with Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Edaravone Product Code: FAB122 | Ferrer Internacional, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | Portugal;France;Spain;Poland;Belgium;Ireland;Russian Federation;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 73 | EUCTR2020-004040-29-ES (EUCTR) | 05/10/2021 | 21/06/2021 | A Clinical Study in which patients diagnosed with Amyotrophic Lateral Sclerosis (ALS) will receive Reldesemtiv (study drug). The safety and efficacy of the drug will be tested. | A Phase 3, Multi-center, Double Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Reldesemtiv in Patients with Amyotrophic Lateral Sclerosis (ALS). - COURAGE-ALS | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: reldesemtiv Product Code: CK-2127107 INN or Proposed INN: reldesemtiv Other descriptive name: RELDESEMTIV | Cytokinetics Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 555 | Phase 3 | United States;Portugal;Spain;Ireland;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Poland;Australia;Germany;Netherlands;Sweden | ||
| 74 | EUCTR2021-000250-26-ES (EUCTR) | 05/10/2021 | 23/07/2021 | A study to investigate the safety and efficacy of AMX0035 in patients with Amyotrophic Lateral Sclerosis | A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of AMX0035 Versus Placebo for 48-week Treatment of Adult Patients with Amyotrophic Lateral Sclerosis (ALS) - Phoenix | ALS (amyotrophic lateral sclerosis) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: AMX0035 INN or Proposed INN: fenilbutirato INN or Proposed INN: Ursodoxicoltaurina Other descriptive name: taurursodiol Product Code: AMX0035 INN or Proposed INN: Fenilbutirato INN or Proposed INN: Ursodoxicoltaurina Other descriptive name: taurursodiol | Amylyx Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | Portugal;France;United States;Poland;Belgium;Spain;Ireland;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 75 | EUCTR2020-003376-40-ES (EUCTR) | 05/10/2021 | 23/06/2021 | A study to investigate the efficacy and safety of FAB122 in patients with Amyotrophic Lateral Sclerosis | A multicenter, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of FAB122 in patients with Amyotrophic Lateral Sclerosis - ADORE (ALS Deceleration with ORal Edaravone) study | Amyotrophic Lateral Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Edaravone Product Code: FAB122 INN or Proposed INN: EDARAVONE | Ferrer Internacional, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | France;Poland;Belgium;Spain;Ireland;Russian Federation;Netherlands;Germany;United Kingdom;Italy | ||
| 76 | JPRN-jRCT2061210031 | 04/10/2021 | 27/08/2021 | EPI-589 Early Phase 2 Investigator-initiated Clinical trial for ALS | EPI-589 Early Phase 2 Investigator-initiated Clinical trial for ALS - EPIC-ALS | Amyotrophic Lateral Sclerosis | EPI-589 500 mg (2 tablets of EPI-589 250 mg) is orally administered three times a day before meals (at least one hour before breakfast, lunch, and dinner). The treatment period will be from the day after the registration of the treatment period to the end of the examination at 24 weeks of the treatment period. | Fujita Koji | NULL | Not Recruiting | >= 18age old | <= 79age old | Both | 10 | Phase 2 | Japan |
| 77 | NCT04993755 (ClinicalTrials.gov) | October 1, 2021 | 19/7/2021 | A Phase 2a Study of TPN-101 in Patients With C9ORF72 ALS/FTD | A Phase 2a Study of TPN-101 in Patients With Amyotrophic Lateral Sclerosis (ALS) and/or Frontotemporal Dementia (FTD) Associated With Hexanucleotide Repeat Expansion in the C9orf72 Gene (C9ORF72 ALS/FTD) | Amyotrophic Lateral Sclerosis;Frontotemporal Dementia | Drug: TPN-101, 400 mg/day;Drug: Placebo | Transposon Therapeutics, Inc. | NULL | Active, not recruiting | 18 Years | N/A | All | 42 | Phase 2 | United States;Belgium;France;Germany;Spain;Netherlands |
| 78 | EUCTR2020-003376-40-IT (EUCTR) | 28/09/2021 | 19/10/2021 | A study to investigate the efficacy and safety of FAB122 in patients with Amyotrophic Lateral Sclerosis | A multicenter, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of FAB122 in patients with Amyotrophic Lateral Sclerosis - - | Amyotrophic Lateral Sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Edaravone Product Code: [FAB122] INN or Proposed INN: Edaravone Other descriptive name: Norphenazone; methylphenylpyrazolone; norantipyrine; 3-methyl-1-phenyl-4, 5-dihydro-1H-pyrazol-5-one. | Ferrer Internacional S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | France;Spain;Poland;Belgium;Ireland;Russian Federation;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 79 | NCT04948645 (ClinicalTrials.gov) | September 22, 2021 | 23/6/2021 | A Phase 1 Study to Investigate the Safety and Pharmacokinetics of ABBV-CLS-7262 in Patients With Amyotrophic Lateral Sclerosis | A Randomized, Double-Blind, Placebo-Controlled Study to Assess Safety, Tolerability, and Pharmacokinetics Following Multiple Doses of ABBV-CLS-7262 in Subjects With Amyotrophic Lateral Sclerosis Followed by an Active Treatment Extension | ALS;Amyotrophic Lateral Sclerosis | Drug: ABBV-CLS-7262;Drug: Placebo | Calico Life Sciences LLC | AbbVie | Active, not recruiting | 18 Years | 80 Years | All | 31 | Phase 1 | United States;Canada |
| 80 | EUCTR2019-001862-13-DK (EUCTR) | 21/09/2021 | 30/06/2020 | Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS) | A prospective, multicenter, randomised, double-blind, placebo-controlled, parallel groups, phase 3 study to compare the efficacy and safety of masitinib in combination with Riluzole versus placebo in combination with Riluzole in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - not applicable | patients suffering from Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: na Product Name: masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: na | AB Science | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 495 | Phase 3 | United States;Portugal;Slovenia;Spain;Ukraine;Ireland;Israel;Russian Federation;United Kingdom;Italy;France;Canada;Argentina;Belgium;Poland;Denmark;Norway;Sweden | ||
| 81 | EUCTR2020-004040-29-IT (EUCTR) | 20/09/2021 | 30/08/2021 | A Clinical Study in which patients diagnosed with Amyotrophic Lateral Sclerosis (ALS) will receive Reldesemtiv (study drug). The safety and efficacy of the drug will be tested | A Phase 3, Multi-center, Double Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Reldesemtiv in Patients with Amyotrophic Lateral Sclerosis (ALS) - COURAGE-ALS | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: reldesemtiv Product Code: [CK-2127107] INN or Proposed INN: reldesemtiv | CYTOKINETICS, INC. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 555 | Phase 3 | United States;Portugal;Spain;Ireland;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Poland;Australia;Germany;Netherlands;Sweden | ||
| 82 | EUCTR2020-004590-51-DE (EUCTR) | 15/09/2021 | 19/03/2021 | A Study of BIIB067 When Initiated in Clinically Presymptomatic Adults With a Confirmed Superoxide Dismutase 1 Mutation | A Phase 3 Randomized, Placebo-Controlled Trial With a Longitudinal Natural History Run-In and Open-Label Extension to Evaluate BIIB067 Initiated in Clinically Presymptomatic Adults With a Confirmed Superoxide Dismutase 1 Mutation - ATLAS | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 20.0;Level: PT;Classification code 10077024;Term: Familial amyotrophic lateral sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 21.1;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10052653;Term: Amyotrophic lateral sclerosis gene carrier;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: BIIB067 (ISIS666853) INN or Proposed INN: tofersen Other descriptive name: BIIB067 | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | United States;Spain;Russian Federation;United Kingdom;Italy;France;Canada;Brazil;Belgium;Poland;Australia;Germany;Japan;Sweden;Korea, Republic of | ||
| 83 | EUCTR2020-004040-29-SE (EUCTR) | 07/09/2021 | 01/06/2021 | A Clinical Study in which patients diagnosed with Amyotrophic Lateral Sclerosis (ALS) will receive Reldesemtiv (study drug). The safety and efficacy of the drug will be tested. | A Phase 3, Multi-center, Double Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Reldesemtiv in Patients with Amyotrophic Lateral Sclerosis (ALS). - COURAGE-ALS | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: reldesemtiv Product Code: CK-2127107 INN or Proposed INN: reldesemtiv Other descriptive name: RELDESEMTIV | Cytokinetics Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 555 | Phase 3 | United States;Portugal;Spain;Ireland;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Poland;Australia;Germany;Netherlands;Sweden | ||
| 84 | EUCTR2021-000250-26-NL (EUCTR) | 03/09/2021 | 06/07/2021 | A study to investigate the safety and efficacy of AMX0035 in patients with Amyotrophic Lateral Sclerosis | A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of AMX0035 Versus Placebo for 48-week Treatment of Adult Patients with Amyotrophic Lateral Sclerosis (ALS) - Phoenix | ALS (amyotrophic lateral sclerosis) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: AMX0035 INN or Proposed INN: phenylbutyrate INN or Proposed INN: Ursodoxicoltaurine Other descriptive name: taurursodiol Product Code: AMX0035 INN or Proposed INN: PHENYLBUTYRATE INN or Proposed INN: Ursodoxicoltaurine Other descriptive name: taurursodiol | Amylyx Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | Portugal;France;United States;Spain;Poland;Belgium;Ireland;Germany;Netherlands;United Kingdom;Italy;Sweden | ||
| 85 | NCT05053035 (ClinicalTrials.gov) | September 2, 2021 | 1/9/2021 | A Phase 2 Study to Evaluate AL001 in C9orf72-Associated ALS | A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AL001 in C9orf72-Associated Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis | Drug: AL001;Drug: Placebo | Alector Inc. | NULL | Active, not recruiting | 18 Years | N/A | All | 45 | Phase 2 | United States |
| 86 | EUCTR2021-000250-26-SE (EUCTR) | 26/08/2021 | 28/06/2021 | A study to investigate the safety and efficacy of AMX0035 in patients with Amyotrophic Lateral Sclerosis | A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of AMX0035 Versus Placebo for 48-week Treatment of Adult Patients with Amyotrophic Lateral Sclerosis (ALS) - Phoenix | ALS (amyotrophic lateral sclerosis) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: AMX0035 INN or Proposed INN: phenylbutyrate INN or Proposed INN: Ursodoxicoltaurine Other descriptive name: taurursodiol Product Code: AMX0035 INN or Proposed INN: PHENYLBUTYRATE INN or Proposed INN: Ursodoxicoltaurine Other descriptive name: taurursodiol | Amylyx Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | Portugal;France;United States;Spain;Poland;Belgium;Ireland;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 87 | EUCTR2020-003962-38-SE (EUCTR) | 21/08/2021 | 05/11/2020 | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE 2 STUDY TO ASSESS EFFICACY, LONG TERM SAFETY AND TOLERABILITY OF RT001 IN SUBJECTS WITH AMYOTROPHIC LATERAL SCLEROSIS | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE 2 STUDY TO ASSESS EFFICACY, LONG TERM SAFETY AND TOLERABILITY OF RT001 IN SUBJECTS WITH AMYOTROPHIC LATERAL SCLEROSIS | Amyotrophic Lateral Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: RT001 Product Code: RT001 INN or Proposed INN: Not assigned Other descriptive name: 9-CIS, 12-CIS-11,11-D2-LINOLEIC ACID ETHYL ESTER | Retrotope, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 44 | Phase 2 | Estonia;Netherlands;Sweden | ||
| 88 | EUCTR2020-003376-40-PL (EUCTR) | 18/08/2021 | 09/07/2021 | A study to investigate the efficacy and safety of FAB122 in patients with Amyotrophic Lateral Sclerosis | A multicenter, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of FAB122 in patients with Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Edaravone Product Code: FAB122 INN or Proposed INN: EDARAVONE | Ferrer Internacional, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | Portugal;France;Spain;Belgium;Poland;Ireland;Russian Federation;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 89 | NCT04944784 (ClinicalTrials.gov) | August 16, 2021 | 16/6/2021 | A Study to Evaluate the Efficacy and Safety of Reldesemtiv in Patients With Amyotrophic Lateral Sclerosis (ALS) | A Phase 3, Multi-Center, Double-Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Reldesemtiv in Patients With Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis | Drug: Reldesemtiv;Drug: Placebo | Cytokinetics | NULL | Recruiting | 18 Years | 80 Years | All | 555 | Phase 3 | United States;Australia;Belgium;Canada;Denmark;France;Germany;Ireland;Italy;Netherlands;Poland;Portugal;Spain;Sweden;Switzerland;United Kingdom |
| 90 | NCT05006352 (ClinicalTrials.gov) | August 11, 2021 | 7/8/2021 | A Study to Determine the Safety, Pharmacokinetics, and Pharmacodynamics of DNL343 in Participants With Amyotrophic Lateral Sclerosis | A Phase 1b, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study, Followed by an Open-Label Extension, to Determine the Safety, Pharmacokinetics, and Pharmacodynamics of DNL343 in Participants With Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis | Drug: DNL343;Drug: Placebo | Denali Therapeutics Inc. | NULL | Active, not recruiting | 18 Years | 80 Years | All | 30 | Phase 1 | United States;Netherlands |
| 91 | EUCTR2020-003376-40-BE (EUCTR) | 10/08/2021 | 08/06/2021 | A multicenter, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of FAB122 in patients with Amyotrophic Lateral Sclerosis | A multicenter, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of FAB122 in patients with Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Edaravone Product Code: FAB122 INN or Proposed INN: EDARAVONE | Ferrer Internacional, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | France;Portugal;Spain;Poland;Belgium;Ireland;Russian Federation;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 92 | EUCTR2019-003797-10-NL (EUCTR) | 23/07/2021 | 09/11/2020 | A Study to Evaluate the Safety and Efficacy of Pegcetacoplan in Subjects with ALS | A Phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of pegcetacoplan in subjects with amyotrophic lateral sclerosis (ALS) | Amyotrophic Lateral Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Pegcetacoplan Product Code: APL-2 INN or Proposed INN: PEGCETACOPLAN | Apellis Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 228 | Phase 2 | United States;Czechia;Spain;Ukraine;Ireland;United Kingdom;Italy;France;Czech Republic;Argentina;Brazil;Belgium;Poland;Australia;Netherlands;Germany;Japan | ||
| 93 | EUCTR2021-001989-38-ES (EUCTR) | 08/07/2021 | 14/06/2021 | COMPARISON OF THE COMBINED TREATMENT OF THE LIPOSOMATED POLYPHENOLS CÚRCULA AND RESVERATROL® WITH DUTASTERIDE, IN THE IMPROVEMENT OF PATIENTS WITH ELA WHO ARE BEING TREATED WITH RILUZOLE | IMPACT OF THE COMBINED TREATMENT OF THE LIPOSOMATED POLYPHENOLS CÚRCULA AND RESVERATROL® WITH DUTASTERIDE, IN THE CLINICAL IMPROVEMENT OF PATIENTS WITH ALS TREATED WITH RILUZOLE - IMCRELA | Amyotrophic Lateral Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Dutasterida Product Name: Dutasterida INN or Proposed INN: DUTASTERIDE Other descriptive name: DUTASTERIDE | Facultad de medicina y ciencias de la salud de la Universidad Católica de Valencia | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 2 | Spain | ||
| 94 | EUCTR2020-000376-38-DE (EUCTR) | 06/07/2021 | 19/01/2021 | A Safety Extension Study of Oral Edaravone in Subjects with Amyotrophic Lateral Sclerosis (ALS) | A Phase 3, Multi-center, Open-label, Safety Extension Study of Oral Edaravone Administered over 96 Weeks in Subjects with Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Edaravone Product Code: MT-1186 INN or Proposed INN: EDARAVONE | Mitsubishi Tanabe Pharma Development America, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 140 | Phase 3 | France;United States;Canada;Germany;Italy;Japan | ||
| 95 | EUCTR2020-004040-29-IE (EUCTR) | 02/07/2021 | 09/04/2021 | A Clinical Study in which patients diagnosed with Amyotrophic Lateral Sclerosis (ALS) will receive Reldesemtiv (study drug). The safety and efficacy of the drug will be tested. | A Phase 3, Multi-center, Double Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Reldesemtiv in Patients with Amyotrophic Lateral Sclerosis (ALS). - COURAGE-ALS | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: reldesemtiv Product Code: CK-2127107 INN or Proposed INN: reldesemtiv Other descriptive name: RELDESEMTIV | Cytokinetics Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 555 | Phase 3 | United States;Portugal;Spain;Ireland;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Poland;Australia;Germany;Netherlands;Sweden | ||
| 96 | NCT04788745 (ClinicalTrials.gov) | June 29, 2021 | 2/3/2021 | Targeting Metabolic Flexibility in Amyotrophic Lateral Sclerosis (ALS) | Targeting Metabolic Flexibility in ALS (MetFlex); Safety and Tolerability of Trimetazidine for the Treatment of ALS | Amyotrophic Lateral Sclerosis;Motor Neuron Disease | Drug: Trimetazidine Dihydrochloride | The University of Queensland | FightMND;UMC Utrecht;King's College London;Julius Clinical, The Netherlands | Recruiting | 18 Years | 75 Years | All | 36 | Phase 2 | Australia;Netherlands;United Kingdom |
| 97 | EUCTR2016-003225-41-ES (EUCTR) | 28/06/2021 | 14/06/2021 | Long-Term Evaluation of BIIB067 | An Extension Study to Assess the Long-Term Safety, Tolerability, Pharmacokinetics, and Effect on Disease Progression of BIIB067 Administered to Previously Treated Adults with Amyotrophic Lateral Sclerosis Caused by Superoxide Dismutase 1 Mutation | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 20.0;Level: PT;Classification code 10077024;Term: Familial amyotrophic lateral sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 21.1;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: BIIB067 (ISIS666853) INN or Proposed INN: Tofersen Other descriptive name: BIIB067 | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 183 | Phase 3 | United States;Spain;Israel;United Kingdom;European Union;Canada;Belgium;Poland;Australia;Denmark;Germany;Japan;New Zealand | ||
| 98 | NCT04931862 (ClinicalTrials.gov) | June 28, 2021 | 11/6/2021 | Study of WVE-004 in Patients With C9orf72-associated Amyotrophic Lateral Sclerosis (ALS) or Frontotemporal Dementia (FTD) | A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 1b/2a Study of WVE-004 Administered Intrathecally to Patients With C9orf72-associated Amyotrophic Lateral Sclerosis (ALS) or Frontotemporal Dementia (FTD) | ALS;FTD | Drug: WVE-004;Drug: Placebo | Wave Life Sciences Ltd. | NULL | Active, not recruiting | 18 Years | 80 Years | All | 35 | Phase 1/Phase 2 | Australia;Belgium;Canada;Ireland;Netherlands;New Zealand;Sweden;United Kingdom |
| 99 | EUCTR2020-000579-19-NL (EUCTR) | 25/06/2021 | 29/03/2021 | An international multi-center clinical trial to investigate the efficacy of multiple drug compounds in patients with Amyotrophic Lateral Sclrerosis (ALS). | A Multi-arm, Adaptive, Group-sequential trial NETwork to evaluate drug efficacy in patients with Amyotrophic Lateral Sclerosis (ALS) - MAGNET | Amyotrophic Lateral Sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Lithium Carbonate INN or Proposed INN: Lithium carbonate Other descriptive name: LITHIUM CARBONATE | Stichting TRICALS Foundation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 171 | Phase 3 | Spain;Belgium;Ireland;Australia;Netherlands;United Kingdom;Sweden | ||
| 100 | EUCTR2020-005069-15-NL (EUCTR) | 23/06/2021 | 14/04/2021 | LIGHTHOUSE 2 | RANDOMISED DOUBLE-BLIND PLACEBO-CONTROLLED PHASE 3 TRIAL OF TRIUMEQ IN AMYOTROPHIC LATERAL SCLEROSIS - Lighthouse 2 | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Triumeq Product Name: Triumeq INN or Proposed INN: Dolutegravir INN or Proposed INN: Abacavir INN or Proposed INN: Lamivudine | Stichting TRICALS Foundation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 390 | Phase 3 | Australia;Netherlands;United Kingdom | ||
| 101 | NCT04768972 (ClinicalTrials.gov) | June 14, 2021 | 22/2/2021 | A Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of ION363 in Amyotrophic Lateral Sclerosis Participants With Fused in Sarcoma Mutations (FUS-ALS) | A Phase 1-3 Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Intrathecally Administered ION363 in Amyotrophic Lateral Sclerosis Patients With Fused in Sarcoma Mutations (FUS-ALS) | Amyotrophic Lateral Sclerosis | Drug: ION363;Drug: Placebo | Ionis Pharmaceuticals, Inc. | NULL | Recruiting | 12 Years | N/A | All | 77 | Phase 3 | United States;Belgium;Canada;Korea, Republic of;Netherlands;United Kingdom;Australia |
| 102 | EUCTR2020-004590-51-FR (EUCTR) | 03/06/2021 | 01/04/2021 | A Study of BIIB067 When Initiated in Clinically Presymptomatic Adults With a Confirmed Superoxide Dismutase 1 Mutation | A Phase 3 Randomized, Placebo-Controlled Trial With a Longitudinal Natural History Run-In and Open-Label Extension to Evaluate BIIB067 Initiated in Clinically Presymptomatic Adults With a Confirmed Superoxide Dismutase 1 Mutation - ATLAS | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 20.0;Level: PT;Classification code 10077024;Term: Familial amyotrophic lateral sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 21.1;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10052653;Term: Amyotrophic lateral sclerosis gene carrier;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: BIIB067 (ISIS666853) INN or Proposed INN: tofersen Other descriptive name: BIIB067 | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | United States;Spain;Russian Federation;United Kingdom;Italy;France;Canada;Brazil;Belgium;Poland;Australia;Bulgaria;Germany;Japan;Sweden;Korea, Republic of | ||
| 103 | NCT04856982 (ClinicalTrials.gov) | May 17, 2021 | 20/4/2021 | A Study of BIIB067 When Initiated in Clinically Presymptomatic Adults With a Confirmed Superoxide Dismutase 1 Mutation | A Phase 3 Randomized, Placebo-Controlled Trial With a Longitudinal Natural History Run-In and Open-Label Extension to Evaluate BIIB067 Initiated in Clinically Presymptomatic Adults With a Confirmed Superoxide Dismutase 1 Mutation | Amyotrophic Lateral Sclerosis Associated With a SOD1 Gene Mutation | Drug: BIIB067 (Tofersen);Drug: Placebo | Biogen | NULL | Recruiting | 18 Years | N/A | All | 150 | Phase 3 | United States;Australia;Belgium;Brazil;Canada;France;Germany;Italy;Japan;Korea, Republic of;Poland;Spain;Sweden;United Kingdom;Russian Federation |
| 104 | JPRN-jRCT2071210023 | 17/05/2021 | 17/05/2021 | Clinical Pharmacology Study of EPI-589 | Clinical Pharmacology Study of EPI-589 (DA350101) | Amyotrophic lateral sclerosis | Cohort 1 : multiple oral administration, 750 mg, three times a day, EPI-589 or placebo Cohort 2 : multiple oral administration, 1000 mg, three times a day, EPI-589 or placebo Cohort 3 : multiple oral administration, 1250 mg, three times a day, EPI-589 or placebo Cohort 4 : multiple oral administration, 1500 mg, three times a day, EPI-589 or placebo Cohort 5 : multiple oral administration, 1500 mg, three times a day, EPI-589 or placebo | Hamatani Tatsuto | NULL | Recruiting | >= 20age old | <= 55age old | Male | 40 | Phase 1 | Japan |
| 105 | EUCTR2020-004590-51-ES (EUCTR) | 17/05/2021 | 01/09/2021 | A Study of BIIB067 When Initiated in Clinically Presymptomatic Adults With a Confirmed Superoxide Dismutase 1 Mutation | A Phase 3 Randomized, Placebo-Controlled Trial With a Longitudinal Natural History Run-In and Open-Label Extension to Evaluate BIIB067 Initiated in Clinically Presymptomatic Adults With a Confirmed Superoxide Dismutase 1 Mutation - ATLAS | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 20.0;Level: PT;Classification code 10077024;Term: Familial amyotrophic lateral sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 21.1;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10052653;Term: Amyotrophic lateral sclerosis gene carrier;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: BIIB067 (ISIS666853) INN or Proposed INN: Tofersen Other descriptive name: BIIB067 | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | United States;Spain;Russian Federation;United Kingdom;Italy;France;Canada;Poland;Brazil;Belgium;Australia;Bulgaria;Germany;Japan;Sweden;Korea, Republic of | ||
| 106 | EUCTR2020-005018-17-NL (EUCTR) | 14/05/2021 | 08/04/2021 | Safety and tolerability of Trimetazidine in amyotrophic lateral sclerosis (ALS) | Targeting metabolic flexibility in ALS (MetFlex); Safety and tolerability of Trimetazidine for the treatment of ALS - MetFlex | Patients suffering from amyotrophic lateral sclerosis (ALS);Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Vastarel Product Name: Trimetazidine Product Code: 201600930 | The University of Queensland | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 36 | Phase 2 | Australia;Netherlands | ||
| 107 | EUCTR2019-003797-10-CZ (EUCTR) | 13/05/2021 | 27/10/2020 | A Study to Evaluate the Safety and Efficacy of Pegcetacoplan in Subjects with ALS | A Phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of pegcetacoplan in subjects with amyotrophic lateral sclerosis (ALS) | Amyotrophic Lateral Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Pegcetacoplan Product Code: APL-2 INN or Proposed INN: PEGCETACOPLAN | Apellis Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 228 | Phase 2 | United States;Czechia;Spain;Ukraine;Ireland;United Kingdom;Italy;France;Czech Republic;Argentina;Brazil;Belgium;Poland;Australia;Germany;Netherlands;Japan | ||
| 108 | EUCTR2019-004256-11-DE (EUCTR) | 11/05/2021 | 17/11/2020 | An Efficacy and Safety Study of Oral Edaravone in Subjects with Amyotrophic Lateral Sclerosis (ALS) | A Phase 3b, Multicenter, Randomized, Double-Blind Study to Evaluate Efficacy and Safety of Oral Edaravone Administered for a Period of 48 Weeks in Subjects with Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Edaravone Product Code: MT-1186 INN or Proposed INN: EDARAVONE | Mitsubishi Tanabe Pharma Development America, Inc. (MTDA) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 380 | Phase 3 | France;United States;Canada;Germany;Switzerland;Japan;Italy;Korea, Republic of | ||
| 109 | NCT04849065 (ClinicalTrials.gov) | May 1, 2021 | 15/4/2021 | Clinical Trial on the Use of Cell Therapy in the Treatment of Patients With Amyotrophic Lateral Sclerosis | Clinical Trial in Phase II of Intramuscular Infusion of Autologous Bone Marrow Stem Cells in Patients With Amyotrophic Lateral Sclerosis. | ALS (Amyotrophic Lateral Sclerosis) | Drug: MNC (Mononuclear cells);Drug: Placebo / Saline | Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia | NULL | Not yet recruiting | 18 Years | 70 Years | All | 100 | Phase 2 | Spain |
| 110 | NCT03843710 (ClinicalTrials.gov) | April 30, 2021 | 14/2/2019 | 31P-MRS Imaging to Assess the Effects of CNM-Au8 on Impaired Neuronal Redox State in Amyotrophic Lateral Sclerosis (REPAIR-ALS) | A Phase 2, Pilot Open Label, Sequential Group, Investigator Blinded Study of Magnetic Resonance Spectroscopy (31P-MRS) to Assess the Effects of CNM-Au8 for the Bioenergetic Improvement of Impaired Neuronal Redox State in Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis | Drug: Gold Nanocrystals | Clene Nanomedicine | University of Texas Southwestern Medical Center | Not yet recruiting | 35 Years | 75 Years | All | 24 | Phase 2 | United States |
| 111 | EUCTR2021-000325-26-FR (EUCTR) | 29/04/2021 | 19/02/2021 | Phase 2 safety and tolerability study using ANX005 for ALS | Phase 2a Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of Intravenous ANX005 in Subjects with Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Scelrosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: ANX005 INN or Proposed INN: ANX005 Other descriptive name: IMMUNOGLOBULIN G | Annexon Biosciences | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 25 | Phase 2 | United States;France;Canada | ||
| 112 | EUCTR2019-003797-10-IE (EUCTR) | 06/04/2021 | 03/09/2020 | A Study to Evaluate the Safety and Efficacy of Pegcetacoplan in Subjects with ALS | A Phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of pegcetacoplan in subjects with amyotrophic lateral sclerosis (ALS) | Amyotrophic Lateral Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Aspaveli Product Name: Pegcetacoplan Product Code: APL-2 INN or Proposed INN: PEGCETACOPLAN | Apellis Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 228 | Phase 2 | United States;Czechia;Spain;Ukraine;Ireland;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Belgium;Brazil;Poland;Australia;Netherlands;Germany;Japan | ||
| 113 | NCT04681118 (ClinicalTrials.gov) | March 24, 2021 | 18/12/2020 | Expanded Access Protocol: Repeated Administration of Nurown® (Autologous MSC-NTF Cells) for the Treatment of ALS | Intermediate-size Patient Population Expanded Access Protocol: Repeated Administration of Nurown® (Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors) for the Treatment of Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis | Biological: NurOwn (MSC-NTF cells) | Brainstorm-Cell Therapeutics | NULL | No longer available | 18 Years | 63 Years | All | United States | ||
| 114 | NCT04745299 (ClinicalTrials.gov) | March 23, 2021 | 27/1/2021 | Evaluation the Efficacy and Safety of Mutiple Lenzumestrocel (Neuronata-R® Inj.) Treatment in Patients With ALS | A Double-blind, Randomized, Multicenter, Placebo-Controlled, Parallel, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Lenzumestrocel(Neuronata-R® Inj.) in Patients With Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis | Biological: Lenzumestrocel;Drug: Riluzole;Drug: Placebo Comparator | Corestem, Inc. | NULL | Recruiting | 25 Years | 75 Years | All | 115 | Phase 3 | Korea, Republic of |
| 115 | EUCTR2019-004256-11-IT (EUCTR) | 22/03/2021 | 24/05/2021 | An Efficacy and Safety Study of Oral Edaravone in Subjects with Amyotrophic Lateral Sclerosis (ALS) | A Phase 3b, Multicenter, Randomized, Double-Blind Study to Evaluate Efficacy and Safety of Oral Edaravone Administered for a Period of 48 Weeks in Subjects with Amyotrophic Lateral Sclerosis (ALS) - N/A | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Edaravone Product Code: [MT-1186] | Mitsubishi Tanabe Development America Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 380 | Phase 3 | France;United States;Canada;Germany;Switzerland;Japan;Italy;Korea, Republic of | ||
| 116 | EUCTR2020-000376-38-IT (EUCTR) | 22/03/2021 | 24/05/2021 | A Safety Extension Study of Oral Edaravone in Subjects with Amyotrophic Lateral Sclerosis (ALS) | A Phase 3, Multi-center, Open-label, Safety Extension Study of Oral Edaravone Administered over 96 Weeks in Subjects with Amyotrophic Lateral Sclerosis (ALS) - MT-1186-A03 | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Edaravone Product Code: [MT-1186] INN or Proposed INN: EDARAVONE | Mitsubishi Tanabe Development America Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 3 | France;United States;Canada;Germany;Japan;Italy | ||
| 117 | NCT04762589 (ClinicalTrials.gov) | March 10, 2021 | 17/2/2021 | RT001 in Amyotrophic Lateral Sclerosis | A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Assess Efficacy, Long Term Safety and Tolerability of RT001 in Subjects With Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis | Drug: RT001;Drug: Placebo | Retrotope, Inc. | NULL | Recruiting | 20 Years | 75 Years | All | 40 | Phase 2 | Estonia;Latvia;Netherlands;Sweden |
| 118 | ITMCTR2100004558 | 2021-03-01 | 2021-03-09 | A multicenter, randomized, double-blind, positive drug parallel controlled clinical trial to evaluate the efficacy and safety of Huolingshengji Keli granules for the treatment of amyotrophic lateral sclerosis (ALS). | A multicenter, randomized, double-blind, positive drug parallel controlled clinical trial to evaluate the efficacy and safety of Huolingshengji Keli granules for the treatment of amyotrophic lateral sclerosis (ALS). | Amyotrophic lateral sclerosis | experimental group:Huoling Shengji Keli granules 1 bag + riluzole tablets simulant 1 tablet each time, Bid, oral;control group:Huoling Shengji Keli granules simulant 1 bag + riluzole tablets 1 tablet each time, Bid, oral; | Peking University Third Hospital | NULL | Recruiting | 45 | 70 | Both | experimental group:72;control group:72; | Phase 2 | China |
| 119 | ChiCTR2100044085 | 2021-03-01 | 2021-03-09 | A multicenter, randomized, double-blind, positive drug parallel controlled clinical trial to evaluate the efficacy and safety of Huolingshengji Keli granules for the treatment of amyotrophic lateral sclerosis (ALS). | A multicenter, randomized, double-blind, positive drug parallel controlled clinical trial to evaluate the efficacy and safety of Huolingshengji Keli granules for the treatment of amyotrophic lateral sclerosis (ALS). | Amyotrophic lateral sclerosis | experimental group:Huoling Shengji Keli granules 1 bag + riluzole tablets simulant 1 tablet each time, Bid, oral;control group:Huoling Shengji Keli granules simulant 1 bag + riluzole tablets 1 tablet each time, Bid, oral; | Peking University Third Hospital | NULL | Recruiting | 45 | 70 | Both | experimental group:72;control group:72; | Phase 2 | China |
| 120 | JPRN-jRCT2031200361 | 26/02/2021 | 15/02/2021 | Comparative Bioavailability study of Oral Edaravone Administered orally and via a Nasogastric Tube | A Phase I, Randomized, Open-Label, Crossover-Design, Single-Dose Study to Investigate the Safety, Tolerability and Comparative Bioavailability of Oral Edaravone Administered orally and via a Nasogastric Tube (NGT) in Healthy Adult Subjects | Amyotrophic Lateral Sclerosis | Subjects will receive the edaravone oral suspension orally. And, subjects will receive the edaravone oral suspension via a NGT. | Kondo Kazuoki | NULL | Complete | >= 20age old | <= 45age old | Both | 36 | Phase 1 | Japan |
| 121 | EUCTR2020-003962-38-NL (EUCTR) | 18/02/2021 | 18/01/2021 | A DOUBLE BLIND, PLACEBO-CONTROLLED, STUDY OF RT001 TREATMENT, FOR PATIENTS WITH AMYOTROPHIC LATERAL SCLEROSIS | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE 2 STUDY TO ASSESS EFFICACY, LONG TERM SAFETY AND TOLERABILITY OF RT001 IN SUBJECTS WITH AMYOTROPHIC LATERAL SCLEROSIS | Amyotrophic Lateral Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: RT001 Product Code: RT001 INN or Proposed INN: Not assigned Other descriptive name: 9-CIS, 12-CIS-11,11-D2-LINOLEIC ACID ETHYL ESTER | Retrotope, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 44 | Phase 2 | Estonia;Netherlands;Sweden | ||
| 122 | EUCTR2019-003797-10-DE (EUCTR) | 18/02/2021 | 12/10/2020 | A Study to Evaluate the Safety and Efficacy of Pegcetacoplan in Subjects with ALS | A Phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of pegcetacoplan in subjects with amyotrophic lateral sclerosis (ALS) | Amyotrophic Lateral Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Aspaveli Product Name: Pegcetacoplan Product Code: APL-2 INN or Proposed INN: PEGCETACOPLAN | Apellis Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 228 | Phase 2 | United States;Czechia;Spain;Ukraine;Ireland;United Kingdom;Italy;France;Czech Republic;Argentina;Brazil;Poland;Belgium;Australia;Germany;Netherlands;Japan | ||
| 123 | NCT04632225 (ClinicalTrials.gov) | February 9, 2021 | 29/10/2020 | Safety of Engensis in Participants With Amyotrophic Lateral Sclerosis | A Phase 2a, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Safety of Engensis in Participants With Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis | Biological: Engensis;Other: Placebo | Helixmith Co., Ltd. | NULL | Completed | 18 Years | 80 Years | All | 18 | Phase 2 | United States;Korea, Republic of |
| 124 | EUCTR2019-001862-13-IT (EUCTR) | 03/02/2021 | 06/11/2020 | Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS) | A prospective, multicenter, randomised, double-blind, placebo-controlled, parallel groups, phase 3 study to compare the efficacy and safety of masitinib in combination with Riluzole versus placebo in combination with Riluzole in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - non applicable | Patients suffering from Amyotrophic Lateral Sclerosis (ALS);Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Masitinib mesilate Product Code: [AB1010] INN or Proposed INN: Masitinib mesilate Other descriptive name: 4-[(4-methyl-1-piperazinyl)methyl]-N-[4-methyl-3-[[4-(3-pyridinyl)-2-thiazolyl]amino]phenyl]-benzamide, methane sulphonic acid salt. AB1010base; AB 1003 Product Name: Masitinib mesilate Product Code: [AB1010] INN or Proposed INN: Masitinib mesilate Other descriptive name: 4-[(4-methyl-1-piperazinyl)methyl]-N-[4-methyl-3-[[4-(3-pyridinyl)-2-thiazolyl]amino]phenyl]-benzamide, methane sulphonic acid salt. AB1010base; AB 1003 | AB SCIENCE | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 495 | Phase 3 | United States;Portugal;Slovenia;Spain;Ukraine;Ireland;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Canada;Argentina;Belgium;Poland;Denmark;Norway;Germany;Netherlands;Sweden | ||
| 125 | EUCTR2019-003797-10-IT (EUCTR) | 03/02/2021 | 28/07/2021 | A Study to Evaluate the Safety and Efficacy of Pegcetacoplan in Subjects with ALS | A Phase 2, randomized, double-blind, placebo-controlled, multicenter studyto evaluate the efficacy and safety of pegcetacoplan in subjects with amyotrophic lateral sclerosis (ALS) - MERIDIAN | Amyotrophic Lateral Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Pegcetacoplam Product Code: [APL-2] Other descriptive name: N/A | APELLIS PHARMACEUTCIALS, INC. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 228 | Phase 2 | United States;Czechia;Spain;Ukraine;Ireland;United Kingdom;Italy;France;Czech Republic;Argentina;Brazil;Belgium;Poland;Australia;Germany;Netherlands;Japan | ||
| 126 | EUCTR2019-001862-13-NO (EUCTR) | 03/02/2021 | 20/11/2020 | Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS) | A prospective, multicenter, randomised, double-blind, placebo-controlled, parallel groups, phase 3 study to compare the efficacy and safety of masitinib in combination with Riluzole versus placebo in combination with Riluzole in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - not applicable | patients suffering from Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: na Product Name: masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: na | ABScience | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 495 | Phase 3 | Portugal;United States;Slovenia;Spain;Ukraine;Ireland;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Canada;Argentina;Poland;Belgium;Denmark;Netherlands;Norway;Germany;Sweden | ||
| 127 | EUCTR2020-003962-38-EE (EUCTR) | 02/02/2021 | 03/11/2020 | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE 2 STUDY TO ASSESS EFFICACY, LONG TERM SAFETY AND TOLERABILITY OF RT001 IN SUBJECTS WITH AMYOTROPHIC LATERAL SCLEROSIS | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE 2 STUDY TO ASSESS EFFICACY, LONG TERM SAFETY AND TOLERABILITY OF RT001 IN SUBJECTS WITH AMYOTROPHIC LATERAL SCLEROSIS | Amyotrophic Lateral Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: RT001 Product Code: RT001 INN or Proposed INN: Not assigned Other descriptive name: 9-CIS, 12-CIS-11,11-D2-LINOLEIC ACID ETHYL ESTER | Retrotope, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 44 | Phase 2 | Estonia;Netherlands;Sweden | ||
| 128 | NCT03651349 (ClinicalTrials.gov) | February 1, 2021 | 26/8/2018 | To Determine the Maximum Tolerated Dose (MTD) of HK-001 in Healthy Volunteers | A Phase I Study to Determine the Maximum Tolerated Dose (MTD) of HK-001 and to Evaluate Its Pharmacokinetic Profile in Healthy Volunteers | Amyotrophic Lateral Sclerosis | Drug: HK-001;Drug: Placebo control | Everfront Biotech Co., Ltd. | NULL | Active, not recruiting | 20 Years | N/A | All | 56 | Phase 1 | Taiwan |
| 129 | JPRN-jRCT2031200301 | 25/01/2021 | 15/01/2021 | Efficacy and Safety Study of Oral Edaravone Administered in Subjects With ALS | A Phase 3b, Multicenter, Randomized, Double-Blind Study to Evaluate Efficacy and Safety of Oral Edaravone Administered for a Period of 48 Weeks in Subjects With Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis | Group 1: Oral edaravone administered once daily for 28 days, in Cycles 1 through 12 Group 2: Oral edaravone administered for 14 days, followed by placebo for 14 days in Cycle 1. Subsequently, repeat oral edaravone administered for 10 days followed by placebo for 18 days (regimen denoted as on/off) in Cycles 2 through 12 | Kondo Kazuoki | NULL | Recruiting | >= 18age old | <= 75age old | Both | 380 | Phase 3 | Korea;Germany;United States of America;Canada;France;Switzerland;Italy;Japan |
| 130 | NCT04575727 (ClinicalTrials.gov) | January 8, 2021 | 29/9/2020 | Exploratory Evaluation of [11C]MPC6827 | Exploratory Evaluation of [11C]MPC6827 Pharmacokinetics With Positron Emission Tomography (PET) | Neurodegenerative Diseases;Alzheimer Disease;Amyotrophic Lateral Sclerosis | Drug: [11C]MPC6827 | Columbia University | NULL | Recruiting | 18 Years | N/A | All | 40 | Early Phase 1 | United States |
| 131 | NCT04390386 (ClinicalTrials.gov) | January 1, 2021 | 13/5/2020 | Controlled Study of IC14 for Treatment of ALS | Amyotrophic Lateral Sclerosis Trial: A Randomized, Double-Blind, Placebo-Controlled Study: IC14, a Monoclonal Antibody Against CD14 | Amyotrophic Lateral Sclerosis | Biological: IC14;Other: Placebo | Implicit Bioscience | NULL | Withdrawn | 18 Years | 70 Years | All | 0 | Phase 2 | United States |
| 132 | ChiCTR2000028960 | 2021-01-01 | 2020-01-09 | Exploratory study of low-intensity ultrasound in the disease progression of amyotrophic lateral sclerosis | Exploratory study of low-intensity ultrasound in the disease progression of amyotrophic lateral sclerosis | Amyotrophic lateral sclerosis | experimental group:wearable low-intensity ultrasound and Riluzole;control group:ineffective ultrasound and Riluzole; | University Affiliated Sixth People's Hospital | NULL | Pending | 18 | 70 | Both | experimental group:20;control group:20; | China | |
| 133 | JPRN-jRCT2041200084 | 23/12/2020 | 24/12/2020 | Safety Extension Study of Oral Edaravone Administered in Subjects With Amyotrophic Lateral Sclerosis (ALS) | A Phase 3, Multi-center, Open-label, Safety Extension Study of Oral Edaravone Administered Over 96 Weeks in Subjects With Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis | Oral Edaravone administered once daily for 10 days out of 14, followed by a 14-day drug- free period | Kondo Kazuoki | NULL | Not Recruiting | >= 18age old | Not applicable | Both | 140 | Phase 3 | United States of America;Canada;Germany;France;Italy;Japan |
| 134 | NCT04615923 (ClinicalTrials.gov) | December 18, 2020 | 29/10/2020 | HEALEY ALS Platform Trial - Regimen D Pridopidine | HEALEY ALS Platform Trial - Regimen D Pridopidine | Amyotrophic Lateral Sclerosis | Drug: Pridopidine;Drug: Matching Placebo | Merit E. Cudkowicz, MD | Prilenia Therapeutics | Active, not recruiting | 18 Years | N/A | All | 163 | Phase 2/Phase 3 | United States |
| 135 | EUCTR2016-003225-41-DK (EUCTR) | 16/12/2020 | 09/06/2020 | Long-Term Evaluation of BIIB067 | An Extension Study to Assess the Long-Term Safety, Tolerability, Pharmacokinetics, and Effect on Disease Progression of BIIB067 Administered to Previously Treated Adults with Amyotrophic Lateral Sclerosis Caused by Superoxide Dismutase 1 Mutation | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 20.0;Level: PT;Classification code 10077024;Term: Familial amyotrophic lateral sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 21.1;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: BIIB067 (ISIS666853) INN or Proposed INN: Tofersen Other descriptive name: BIIB067 | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 183 | Phase 3 | United States;Spain;Israel;Italy;United Kingdom;European Union;Canada;Belgium;Poland;Denmark;Australia;Germany;Japan;New Zealand | ||
| 136 | NCT04220190 (ClinicalTrials.gov) | December 15, 2020 | 3/1/2020 | RAPA-501 Therapy for ALS | Phase I Trial of Autologous Hybrid TREG/Th2 Cell (RAPA-501) Therapy for Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis | Biological: RAPA-501 Autologous T cells | Rapa Therapeutics LLC | Massachusetts General Hospital;Hackensack Meridian Health | Recruiting | 18 Years | N/A | All | 18 | Phase 1/Phase 2 | United States |
| 137 | NCT04651855 (ClinicalTrials.gov) | December 2, 2020 | 30/9/2020 | The Evaluation of the Effect of Mesenchymal Stem Cells on the Immune System of Patients With ALS | The Evaluation of the Effect of Wharton's Jelly Mesenchymal Stem Cells (WJMSCs) on the Immune System of Patients With Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis | Drug: Mesenchymal stem cells isolated from Wharton's jelly | Polski Bank Komorek Macierzystych JSC (PBKM) | National Center for Research and Development, Poland | Active, not recruiting | 18 Years | N/A | All | 20 | Phase 1/Phase 2 | Poland |
| 138 | EUCTR2019-001862-13-PL (EUCTR) | 01/12/2020 | 09/07/2020 | Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS) | A prospective, multicenter, randomised, double-blind, placebo-controlled, parallel groups, phase 3 study to compare the efficacy and safety of masitinib in combination with Riluzole versus placebo in combination with Riluzole in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - not applicable | patients suffering from Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: na Product Name: masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: na | AB Science | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 495 | Phase 3 | United States;Portugal;Slovenia;Spain;Ukraine;Ireland;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Canada;Argentina;Poland;Belgium;Denmark;Norway;Germany;Netherlands;Sweden | ||
| 139 | EUCTR2016-003225-41-PL (EUCTR) | 01/12/2020 | 22/07/2020 | Long-Term Evaluation of BIIB067 | An Extension Study to Assess the Long-Term Safety, Tolerability, Pharmacokinetics, and Effect on Disease Progression of BIIB067 Administered to Previously Treated Adults with Amyotrophic Lateral Sclerosis Caused by Superoxide Dismutase 1 Mutation | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 20.0;Level: PT;Classification code 10077024;Term: Familial amyotrophic lateral sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 21.1;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: BIIB067 (ISIS666853) INN or Proposed INN: - Other descriptive name: BIIB067 | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 183 | Phase 3 | United States;European Union;Canada;Argentina;Belgium;Poland;Denmark;Australia;Germany;United Kingdom;Japan;Korea, Republic of | ||
| 140 | NCT04514952 (ClinicalTrials.gov) | November 23, 2020 | 12/8/2020 | Individual Patient Expanded Access IND of Autologous HBadMSCs for the Treatment of Amyotrophic Lateral Sclerosis | Individual Patient Expanded Access IND of Autologous HBadMSCs for the Treatment of Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis | Biological: HB-adMSCs | Hope Biosciences Stem Cell Research Foundation | Hope Biosciences | No longer available | N/A | N/A | All | United States | ||
| 141 | NCT04516096 (ClinicalTrials.gov) | November 22, 2020 | 9/8/2020 | A Compassionate Use Protocol of AMX0035 for Treatment of Patients With Amyotrophic Lateral Sclerosis (ALS) | AMX0035 for Amyotrophic Lateral Sclerosis - Compassionate Use Protocol | Amyotrophic Lateral Sclerosis | Drug: AMX0035 | Amylyx Pharmaceuticals Inc. | NULL | Active, not recruiting | 18 Years | N/A | All | 40 | Phase 2/Phase 3 | United States |
| 142 | EUCTR2015-004098-33-PL (EUCTR) | 18/11/2020 | 10/07/2020 | An Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of BIIB067 in Adults With Inherited Amyotrophic Lateral Sclerosis (ALS) | A Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BIIB067 Administered to Adult Subjects with Amyotrophic Lateral Sclerosis and Confirmed Superoxide Dismutase 1 Mutation - VALOR (Part C) | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 20.0;Level: PT;Classification code 10077024;Term: Familial amyotrophic lateral sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 21.1;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: BIIB067 (ISIS666853) Other descriptive name: BIIB067 | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 183 | Phase 3 | United States;Italy;United Kingdom;France;Canada;Argentina;Poland;Belgium;Australia;Denmark;Germany;Japan;Korea, Republic of;Sweden | ||
| 143 | NCT04569084 (ClinicalTrials.gov) | November 13, 2020 | 23/9/2020 | Efficacy and Safety Study of Oral Edaravone Administered in Subjects With ALS | A Phase 3b, Multicenter, Randomized, Double-Blind Study to Evaluate Efficacy and Safety of Oral Edaravone Administered for a Period of 48 Weeks in Subjects With Amyotrophic Lateral Sclerosis (ALS) | ALS | Drug: MT-1186;Drug: Placebo | Mitsubishi Tanabe Pharma Development America, Inc. | NULL | Active, not recruiting | 18 Years | 75 Years | All | 380 | Phase 3 | United States;Canada;Germany;Italy;Japan;Korea, Republic of;Switzerland |
| 144 | NCT04391361 (ClinicalTrials.gov) | November 1, 2020 | 13/5/2020 | The Safety and Effectiveness of Cholinergic Receptor Block Therapy in the Treatment of ALS | The Safety and Effectiveness of Cholinergic Receptor Block Therapy in the Treatment of Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis;Respiratory Function;Scopolamine | Drug: Scopolamine, atropine, edaravone and dexmedetomidine;Drug: Edaravone | Ruijin Hospital | NULL | Not yet recruiting | 30 Years | 65 Years | All | 30 | Phase 2 | China |
| 145 | NCT04577404 (ClinicalTrials.gov) | October 29, 2020 | 30/9/2020 | Safety Extension Study of Oral Edaravone Administered in Subjects With Amyotrophic Lateral Sclerosis (ALS) | A Phase 3, Multi-center, Open-label, Safety Extension Study of Oral Edaravone Administered Over 96 Weeks in Subjects With Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis (ALS) | Drug: MT-1186 | Mitsubishi Tanabe Pharma Development America, Inc. | NULL | Active, not recruiting | 18 Years | N/A | All | 140 | Phase 3 | United States;Canada;France;Germany;Italy;Japan |
| 146 | EUCTR2019-001862-13-SE (EUCTR) | 14/10/2020 | 23/03/2020 | Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS) | A prospective, multicenter, randomised, double-blind, placebo-controlled, parallel groups, phase 3 study to compare the efficacy and safety of masitinib in combination with Riluzole versus placebo in combination with Riluzole in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - not applicable | patients suffering from Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: na Product Name: masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: na | ABScience | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 495 | Phase 3 | Portugal;United States;Slovenia;Spain;Ireland;Israel;Russian Federation;United Kingdom;Italy;France;Canada;Argentina;Belgium;Poland;Denmark;Norway;Germany;Netherlands;Sweden | ||
| 147 | NCT04562831 (ClinicalTrials.gov) | October 7, 2020 | 10/9/2020 | The NO-ALS Study: A Trial of Nicotinamide/Pterostilbene Supplement in ALS. | A Randomized Placebo-controlled Trial of Nicotinamide/Pterostilbene Supplement in ALS: The NO-ALS Study | Amyotrophic Lateral Sclerosis | Dietary Supplement: EH301 (Nicotinamide Riboside/Pterostilbene) | Haukeland University Hospital | Elysium Health | Recruiting | 35 Years | N/A | All | 380 | N/A | Norway |
| 148 | ChiCTR2000035988 | 2020-10-01 | 2020-08-21 | Exploratory study of wearable low-intensity ultrasound in the disease progression of Amyotrophic lateral sclerosis | Exploratory study of wearable low-intensity ultrasound in the disease progression of Amyotrophic lateral sclerosis | Amyotrophic lateral sclerosis | experimental group:wearable low-intenstiy ultrasound + riluzole;control group:invalid ultrasound + riluzole; | Shanghai Sixth People's Hospital | NULL | Pending | 18 | 70 | Both | experimental group:25;control group:25; | China | |
| 149 | NCT03127267 (ClinicalTrials.gov) | October 1, 2020 | 13/4/2017 | Efficacy and Safety of Masitinib Versus Placebo in the Treatment of ALS Patients | A Prospective, Multicenter, Randomised, Double-blind, Placebo-controlled, Parallel Groups, Phase 3 Study to Compare the Efficacy and Safety of Masitinib in Combination With Riluzole Versus Placebo in Combination With Riluzole in the Treatment of Patients Suffering From Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis | Drug: Masitinib (6.0);Drug: Riluzole;Drug: Placebo;Drug: Masitinib (4.5) | AB Science | NULL | Recruiting | 18 Years | 81 Years | All | 495 | Phase 3 | United States;Germany;Canada |
| 150 | NCT04579666 (ClinicalTrials.gov) | September 30, 2020 | 22/9/2020 | MERIDIAN: A Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Adults With Amyotrophic Lateral Sclerosis (ALS) | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Subjects With Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis;Motor Neuron Disease | Drug: Pegcetacoplan (APL-2);Other: Placebo | Apellis Pharmaceuticals, Inc. | NULL | Active, not recruiting | 18 Years | N/A | All | 249 | Phase 2 | United States;Australia;Belgium;Czechia;France;Germany;Ireland;Italy;Japan;Netherlands;Poland;Spain;Ukraine;United Kingdom |
| 151 | NCT04494256 (ClinicalTrials.gov) | September 28, 2020 | 30/7/2020 | A Study to Assess the Safety, Tolerability, and Effect on Disease Progression of BIIB105 in Participants With Amyotrophic Lateral Sclerosis (ALS) and Participants With the ALS Ataxin-2 (ATXN2) Genetic Mutation | A Phase 1/2 Multiple-Ascending-Dose Study With a Long-Term Open-Label Extension to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Effect on Disease Progression of BIIB105 Administered Intrathecally to Adults With Amyotrophic Lateral Sclerosis With or Without Poly-CAG Expansion in the Ataxin-2 Gene | Amyotrophic Lateral Sclerosis | Drug: BIIB105;Drug: Placebo | Biogen | NULL | Recruiting | 18 Years | N/A | All | 98 | Phase 1/Phase 2 | United States;Canada;Italy;Netherlands |
| 152 | NCT04557410 (ClinicalTrials.gov) | September 23, 2020 | 31/5/2020 | Open Label Study: Treatment of ALS Fatigue With PolyMVA | Open Label Study: Treatment of ALS Fatigue With PolyMVA | Amyotrophic Lateral Sclerosis | Drug: PolyMVA | University of Missouri-Columbia | Band of Hope Foundation | Completed | N/A | N/A | All | 12 | Phase 1 | United States |
| 153 | EUCTR2019-001862-13-ES (EUCTR) | 15/09/2020 | 12/06/2020 | Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS) | A prospective, multicenter, randomised, double-blind, placebo-controlled, parallel groups, phase 3 study to compare the efficacy and safety of masitinib in combination with Riluzole versus placebo in combination with Riluzole in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - not applicable | patients suffering from Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: na Product Name: masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: na | ABScience | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 495 | Phase 3 | United States;Portugal;Slovenia;Spain;Ireland;Russian Federation;Israel;United Kingdom;Italy;France;Canada;Argentina;Belgium;Poland;Denmark;Norway;Germany;Netherlands;Sweden | ||
| 154 | EUCTR2019-004619-30-IE (EUCTR) | 14/09/2020 | 03/02/2020 | An Efficacy and Safety Study of Ravulizumab in ALS Patients | A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter Study With an Open-Label Extension to Evaluate the Efficacy and Safety of Ravulizumab in Patients With Amyotrophic Lateral Sclerosis (ALS) - An Efficacy and Safety Study of Ravulizumab in ALS Patients | Amyotrophic Lateral Sclerosis (ALS), motor neuron disease MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Trade Name: Ultomiris Product Name: ravulizumab Product Code: ALXN1210 INN or Proposed INN: RAVULIZUMAB | Alexion Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 354 | Phase 3 | United States;Spain;Ireland;Israel;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Poland;Australia;Denmark;Germany;Netherlands;Japan;Sweden;Korea, Republic of | ||
| 155 | NCT04428775 (ClinicalTrials.gov) | September 8, 2020 | 3/6/2020 | A Safety and Biomarker Study of ALZT-OP1a in Subjects With Mild-Moderate ALS Disease | A Phase IIa, Randomized, Open-label, Multi-Center, Multi-Dose Study to Evaluate the Effects of ALZT-OP1a in Subjects With Mild-Moderate Stage Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis | Drug: ALZT-OP1a (cromolyn) | AZTherapies, Inc. | NULL | Terminated | 18 Years | 75 Years | All | 12 | Phase 2 | United States |
| 156 | NCT04518540 (ClinicalTrials.gov) | September 1, 2020 | 5/8/2020 | Explore Neuroprotective Effect of Lipoic Acid in Amyotrophic Lateral Sclerosis | Randomized, Parallel Safety and Efficacy Study of Lipoic Acid in Patients With Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis | Drug: lipoic acid group;Drug: control group | Second Affiliated Hospital, School of Medicine, Zhejiang University | NULL | Recruiting | 20 Years | 75 Years | All | 150 | N/A | China |
| 157 | NCT04499963 (ClinicalTrials.gov) | August 28, 2020 | 31/7/2020 | Trial of Theracurmin for Patients With Amyotrophic Lateral Sclerosis (ALS) | An Open-label, Single-center, 6-month Trial of Theracurmin for Patients With Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis | Drug: Theracurmin HP | Richard Bedlack, M.D., Ph.D. | NULL | Completed | 18 Years | N/A | All | 68 | Phase 2 | United States |
| 158 | EUCTR2019-004619-30-DK (EUCTR) | 12/08/2020 | 03/03/2020 | An Efficacy and Safety Study of Ravulizumab in ALS Patients | A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter Study With an Open-Label Extension to Evaluate the Efficacy and Safety of Ravulizumab in Patients With Amyotrophic Lateral Sclerosis (ALS) - An Efficacy and Safety Study of Ravulizumab in ALS Patients | Amyotrophic Lateral Sclerosis (ALS), motor neuron disease MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Trade Name: Ultomiris Product Name: ravulizumab Product Code: ALXN1210 INN or Proposed INN: RAVULIZUMAB | Alexion Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 354 | Phase 3 | France;Canada;Belgium;Poland;Denmark;Australia;Germany;Netherlands;Japan;Sweden;United States;Spain;Ireland;Israel;United Kingdom;Switzerland;Italy | ||
| 159 | EUCTR2019-004619-30-DE (EUCTR) | 07/08/2020 | 11/02/2020 | An Efficacy and Safety Study of Ravulizumab in ALS Patients | A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter Study With an Open-Label Extension to Evaluate the Efficacy and Safety of Ravulizumab in Patients With Amyotrophic Lateral Sclerosis (ALS) - An Efficacy and Safety Study of Ravulizumab in ALS Patients | Amyotrophic Lateral Sclerosis (ALS), motor neuron disease MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Trade Name: Ultomiris Product Name: ravulizumab Product Code: ALXN1210 INN or Proposed INN: RAVULIZUMAB | Alexion Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 354 | Phase 3 | United States;Spain;Ireland;Israel;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Poland;Australia;Denmark;Germany;Netherlands;Japan;Sweden | ||
| 160 | EUCTR2018-004171-12-PL (EUCTR) | 22/07/2020 | 05/09/2019 | The evaluation of the effect of Wharton’s Jelly Mesenchymal Stem Cells (WJMSCs) on the immune system of patients with Amyotrophic Lateral Sclerosis (ALS) | The evaluation of the effect of Wharton’s Jelly Mesenchymal Stem Cells (WJMSCs) on the immune system of patients with Amyotrophic Lateral Sclerosis (ALS) - ALSTEM | Amyotrophic Lateral Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: FamC-1 INN or Proposed INN: WHARTON’S JELLY-DERIVED MESENCHYMAL STEM CELLS Other descriptive name: WHARTON’S JELLY-DERIVED MESENCHYMAL STEM CELLS | Polski Bank Komórek Macierzystych JSC (PBKM) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Phase 1;Phase 2 | Poland | ||
| 161 | NCT04297683 (ClinicalTrials.gov) | July 14, 2020 | 3/3/2020 | HEALEY ALS Platform Trial - Master Protocol | HEALEY ALS Platform Trial | Amyotrophic Lateral Sclerosis | Drug: Zilucoplan;Drug: Verdiperstat;Drug: CNM-Au8;Drug: Pridopidine;Drug: SLS-005 Trehalose | Merit E. Cudkowicz, MD | Massachusetts General Hospital | Recruiting | 18 Years | N/A | All | 800 | Phase 2/Phase 3 | United States |
| 162 | EUCTR2019-004619-30-IT (EUCTR) | 03/07/2020 | 17/01/2022 | An Efficacy and Safety Study of Ravulizumab in ALS Patients | A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter Study With an Open-Label Extension to Evaluate the Efficacy and Safety of Ravulizumab in Patients With Amyotrophic Lateral Sclerosis (ALS) - An Efficacy and Safety Study of Ravulizumab in ALS Patients | Amyotrophic Lateral Sclerosis (ALS), motor neuron disease MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Trade Name: Ultomiris Product Name: ravulizumab Product Code: [ALXN1210] INN or Proposed INN: RAVULIZUMAB Other descriptive name: RAVULIZUMAB | ALEXION PHARMACEUTICALS INCORPORATED | NULL | Not Recruiting | Female: yes Male: yes | 354 | Phase 3 | United States;Spain;Ireland;Israel;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Poland;Australia;Denmark;Germany;Netherlands;Japan;Sweden;Korea, Republic of | ||
| 163 | NCT03766321 (ClinicalTrials.gov) | July 1, 2020 | 30/11/2018 | Fecal Microbiota Transplantation Effect on Amyotrophic Lateral Sclerosis Patients | Interplay Between Gut Microbiota and Adaptive Immunity in Amyotrophic Lateral Sclerosis: a Clinical Trial | Amyotrophic Lateral Sclerosis | Biological: Fecal microbiota transplantation;Biological: Placebo | Azienda Ospedaliero-Universitaria di Modena | University of Modena and Reggio Emilia;Catholic University of the Sacred Heart;Campus Bio-Medico University;Azienda Ospedaliero-Universitaria Careggi;Azienda Ospedaliera di Perugia;University of Chieti;University of Florence | Active, not recruiting | 18 Years | 70 Years | All | 42 | N/A | Italy |
| 164 | EUCTR2019-004619-30-SE (EUCTR) | 22/06/2020 | 04/02/2020 | An Efficacy and Safety Study of Ravulizumab in ALS Patients | A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter Study With an Open-Label Extension to Evaluate the Efficacy and Safety of Ravulizumab in Patients With Amyotrophic Lateral Sclerosis (ALS) - An Efficacy and Safety Study of Ravulizumab in ALS Patients | Amyotrophic Lateral Sclerosis (ALS), motor neuron disease MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Trade Name: Ultomiris Product Name: ravulizumab Product Code: ALXN1210 INN or Proposed INN: RAVULIZUMAB | Alexion Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 354 | Phase 3 | United States;Spain;Ireland;Israel;United Kingdom;Switzerland;Italy;France;Canada;Poland;Belgium;Australia;Denmark;Germany;Netherlands;Japan;Sweden | ||
| 165 | NCT04950933 (ClinicalTrials.gov) | June 1, 2020 | 27/6/2021 | The Treatment of Amyotrophic Lateral Sclerosis With Huollingshengji Granules | A Multi-center, Randomized, Double-blind, Positives Parallel Controlled, Phase ? Clinical Trial to Evaluate the Efficacy and Safety of Huollingshengji Granules in the Treatment of Amyotrophic Lateral Sclerosis (Spleen qi Deficiency, Kidney Yang Deficiency Syndrome) | Amyotrophic Lateral Sclerosis | Drug: Huolingshengji Granules;Drug: Riluzole tablet | Peking University Third Hospital | The Second Hospital of Hebei Medical University | Recruiting | 45 Years | 70 Years | All | 144 | Phase 2/Phase 3 | China |
| 166 | NCT04057898 (ClinicalTrials.gov) | May 28, 2020 | 6/8/2019 | Evaluation of MN-166 (Ibudilast) for 12 Months Followed by an Open-label Extension for 6 Months in Patients With ALS | A Phase 2b/3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 12 Month Clinical Trial to Evaluate the Efficacy and Safety of MN-166 (Ibudilast) Followed by Open-Label Extension Phase in Subjects With Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis | Drug: MN-166;Drug: placebo | MediciNova | NULL | Recruiting | 18 Years | 80 Years | All | 230 | Phase 2/Phase 3 | United States;Canada |
| 167 | EUCTR2019-004619-30-GB (EUCTR) | 26/05/2020 | 07/02/2020 | An Efficacy and Safety Study of Ravulizumab in ALS Patients | A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter Study With an Open-Label Extension to Evaluate the Efficacy and Safety of Ravulizumab in Patients With Amyotrophic Lateral Sclerosis (ALS) - An Efficacy and Safety Study of Ravulizumab in ALS Patients | Amyotrophic Lateral Sclerosis (ALS), motor neuron disease MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Trade Name: Ultomiris Product Name: Ultomiris Product Code: ALXN1210 INN or Proposed INN: RAVULIZUMAB | Alexion Pharmaceuticals | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 354 | Phase 3 | United States;Spain;Ireland;Israel;Switzerland;United Kingdom;Italy;France;Canada;Poland;Belgium;Australia;Denmark;Germany;Netherlands;Japan;Sweden;Korea, Republic of | ||
| 168 | EUCTR2019-004619-30-FR (EUCTR) | 20/05/2020 | 20/08/2020 | An Efficacy and Safety Study of Ravulizumab in ALS Patients | A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter Study With an Open-Label Extension to Evaluate the Efficacy and Safety of Ravulizumab in Patients With Amyotrophic Lateral Sclerosis (ALS) - An Efficacy and Safety Study of Ravulizumab in ALS Patients | Amyotrophic Lateral Sclerosis (ALS), motor neuron disease MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Trade Name: Ultomiris Product Name: ravulizumab Product Code: ALXN1210 INN or Proposed INN: RAVULIZUMAB | Alexion Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 354 | Phase 3 | United States;Spain;Ireland;Israel;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Poland;Australia;Denmark;Germany;Netherlands;Japan;Sweden;Korea, Republic of | ||
| 169 | EUCTR2019-004619-30-ES (EUCTR) | 14/05/2020 | 06/03/2020 | An Efficacy and Safety Study of Ravulizumab in ALS Patients | A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter Study With an Open-Label Extension to Evaluate the Efficacy and Safety of Ravulizumab in Patients With Amyotrophic Lateral Sclerosis (ALS) - An Efficacy and Safety Study of Ravulizumab in ALS Patients | Amyotrophic Lateral Sclerosis (ALS), motor neuron disease MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Trade Name: Ultomiris Product Name: ravulizumab Product Code: ALXN1210 INN or Proposed INN: RAVULIZUMAB | Alexion Pharmaceuticals | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 354 | Phase 3 | France;Canada;Poland;Belgium;Australia;Denmark;Germany;Netherlands;United States;Spain;Ireland;Israel;United Kingdom;Switzerland;Italy;Japan;Sweden;Korea, Republic of | ||
| 170 | EUCTR2019-002108-41-DE (EUCTR) | 06/05/2020 | 17/01/2020 | A Safety Study of Oral Edaravone in Subjects with Amyotrophic Lateral Sclerosis (ALS) | A Phase 3, Multi-center, Open-label, Safety Study of Oral Edaravone Administered over 48 Weeks in Subjects with Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Edaravone Product Code: MT-1186 INN or Proposed INN: EDARAVONE | Mitsubishi Tanabe Pharma Development America, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | France;United States;Canada;Germany;Italy;Japan | ||
| 171 | NCT04288856 (ClinicalTrials.gov) | April 28, 2020 | 26/2/2020 | Study to Assess the Safety, Tolerability, Pharmacokinetics, and Effect on Disease Progression of BIIB078 Administered to Previously Treated Adults C9ORF72-Associated Amyotrophic Lateral Sclerosis (ALS) | An Extension Study to Assess the Long-Term Safety, Tolerability, Pharmacokinetics, and Effect on Disease Progression of BIIB078 Administered to Previously Treated Adults With C9ORF72-Associated Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis | Drug: BIIB078 | Biogen | NULL | Terminated | 18 Years | N/A | All | 75 | Phase 1 | United States;Canada;Netherlands;Switzerland;United Kingdom |
| 172 | EUCTR2020-000352-36-DK (EUCTR) | 27/04/2020 | 13/02/2020 | Metabolic MRI of amyotrophic lateral sclerosis and mini strokes | MRI of neurometabolic impairment in ALS and TIA using hyperpolarized pyruvate | Amyotrophic lateral sclerosisTransient ischemic attack MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05] | Product Name: Hyperpolarized [1-13C]pyruvate INN or Proposed INN: SODIUM PYRUVATE Other descriptive name: SODIUM PYRUVATE | Christoffer Laustsen | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 46 | Phase 2 | Denmark | ||
| 173 | EUCTR2019-002108-41-IT (EUCTR) | 24/04/2020 | 17/06/2021 | A Safety Study of Oral Edaravone in Subjects with Amyotrophic Lateral Sclerosis (ALS) | A Phase 3, Multi-center, Open-label, Safety Study of Oral Edaravone Administered over 48 Weeks in Subjects with Amyotrophic Lateral Sclerosis (ALS) - n/a | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Edaravone Product Code: [MT-1186] | Mitsubishi Tanabe Development America Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | France;United States;Canada;Germany;Japan;Italy | ||
| 174 | EUCTR2019-004619-30-NL (EUCTR) | 23/04/2020 | 09/03/2020 | An Efficacy and Safety Study of Ravulizumab in ALS Patients | A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter Study With an Open-Label Extension to Evaluate the Efficacy and Safety of Ravulizumab in Patients With Amyotrophic Lateral Sclerosis (ALS) - An Efficacy and Safety Study of Ravulizumab in ALS Patients | Amyotrophic Lateral Sclerosis (ALS), motor neuron disease MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Trade Name: Ultomiris Product Name: ravulizumab Product Code: ALXN1210 INN or Proposed INN: RAVULIZUMAB | Alexion Pharmaceuticals | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 354 | Phase 3 | United States;Spain;Ireland;Israel;United Kingdom;Switzerland;Italy;France;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Japan;Sweden;Korea, Republic of | ||
| 175 | NCT04326283 (ClinicalTrials.gov) | April 2, 2020 | 24/3/2020 | Trial of Safety, Tolerability and Efficacy of Trametinib (SNR1611) in Patients With Amyotrophic Lateral Sclerosis (ALS) | A Sequential Dose-Escalation, Randomized, Active-Controlled, Multi-Center, Phase 1/2a Clinical Trial to Evaluate the Safety, Tolerability and Efficacy of SNR1611 in Patients With Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis | Drug: Trametinib (0.5 mg);Drug: Trametinib (1 mg);Drug: Riluzole (100 mg) | Genuv Inc. | NULL | Recruiting | 19 Years | 75 Years | All | 30 | Phase 1/Phase 2 | Korea, Republic of |
| 176 | NCT04248465 (ClinicalTrials.gov) | March 30, 2020 | 27/1/2020 | An Efficacy and Safety Study of Ravulizumab in ALS Participants | A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter Study With an Open-Label Extension to Evaluate the Efficacy and Safety of Ravulizumab in Patients With Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis;ALS | Drug: Placebo;Biological: Ravulizumab | Alexion Pharmaceuticals | NULL | Active, not recruiting | 18 Years | N/A | All | 382 | Phase 3 | United States;Australia;Belgium;Canada;Denmark;France;Germany;Ireland;Israel;Italy;Japan;Netherlands;Poland;Spain;Sweden;Switzerland;United Kingdom |
| 177 | EUCTR2015-004098-33-DK (EUCTR) | 23/03/2020 | 02/03/2020 | An Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of BIIB067 in Adults With Inherited Amyotrophic Lateral Sclerosis (ALS) | A Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BIIB067 Administered to Adult Subjects with Amyotrophic Lateral Sclerosis and Confirmed Superoxide Dismutase 1 Mutation - VALOR (Part C) | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 20.0;Level: PT;Classification code 10077024;Term: Familial amyotrophic lateral sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 21.1;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: BIIB067 (ISIS666853) INN or Proposed INN: Tofersen Other descriptive name: BIIB067 | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 183 | Phase 1;Phase 2;Phase 3 | France;United States;Canada;Poland;Belgium;Australia;Denmark;Germany;United Kingdom;Italy;Japan;Sweden | ||
| 178 | NCT04313166 (ClinicalTrials.gov) | March 19, 2020 | 15/3/2020 | Treatment Continuation Study for Patients With ALS/MND Who Completed Study CMD-2019-001 | A Treatment Continuation Study for Patients With Amyotrophic Lateral Sclerosis/Motor Neuron Disease Who Have Successfully Complete Study CMD-2019-001 | Amyotrophic Lateral Sclerosis | Drug: Cu(II)ATSM | Collaborative Medicinal Development Pty Limited | NULL | Completed | 18 Years | 75 Years | All | 55 | Phase 2 | Australia |
| 179 | EUCTR2019-001862-13-SI (EUCTR) | 12/03/2020 | 19/02/2020 | Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS) | A prospective, multicenter, randomised, double-blind, placebo-controlled, parallel groups, phase 3 study to compare the efficacy and safety of masitinib in combination with Riluzole versus placebo in combination with Riluzole in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - not applicable | patients suffering from Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: na Product Name: masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: na | ABScience | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 495 | Phase 3 | United States;Portugal;Slovenia;Spain;Ukraine;Ireland;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Canada;Argentina;Belgium;Poland;Denmark;Germany;Netherlands;Sweden | ||
| 180 | EUCTR2019-003549-14-HU (EUCTR) | 11/03/2020 | 13/01/2020 | A Clinical Trial To Evaluate The Efficacy And Safety Of Mn-166 (Ibudilast) In Subjects With Amyotrophic Lateral Sclerosis(Lou Gehrig's disease) | A PHASE 2B/3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 12 MONTH CLINICAL TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF MN-166 (IBUDILAST) FOLLOWED BY AN OPEN-LABEL EXTENSION IN SUBJECTS WITH AMYOTROPHIC LATERAL SCLEROSIS - COMBAT-ALS | Amyotrophic Lateral Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ibudilast Product Code: MN-166 INN or Proposed INN: IBUDILAST | MediciNova, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 230 | Phase 2;Phase 3 | United States;Hungary;Greece;Poland;Spain;Germany;Italy | ||
| 181 | NCT04302870 (ClinicalTrials.gov) | February 27, 2020 | 4/3/2020 | Motor Neurone Disease - Systematic Multi-Arm Adaptive Randomised Trial | Motor Neurone Disease - Systematic Multi-Arm Adaptive Randomised Trial | Motor Neuron Disease, Amyotrophic Lateral Sclerosis | Drug: Memantine Hydrochloride Oral Solution;Drug: Trazodone Hydrochloride oral solution;Drug: Placebo oral solution | University of Edinburgh | University College, London;University of Warwick;NHS Lothian | Recruiting | 18 Years | N/A | All | 750 | Phase 2/Phase 3 | United Kingdom |
| 182 | EUCTR2016-003225-41-IT (EUCTR) | 10/02/2020 | 15/06/2021 | Long-Term Evaluation of BIIB067 | An Extension Study to Assess the Long-Term Safety, Tolerability, Pharmacokinetics, and Effect on Disease Progression of BIIB067 Administered to Previously Treated Adults with Amyotrophic Lateral Sclerosis Caused by Superoxide Dismutase 1 Mutation - na | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 20.0;Level: PT;Classification code 10077024;Term: Familial amyotrophic lateral sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 21.1;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: nd Product Code: [BIIB067 (ISIS666853)] | BIOGEN IDEC RESEARCH LIMITED | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 182 | Phase 3 | United States;European Union;Canada;Spain;Poland;Belgium;Denmark;Australia;Germany;United Kingdom;Japan;Italy | ||
| 183 | NCT04245709 (ClinicalTrials.gov) | February 10, 2020 | 26/1/2020 | Clenbuterol on Motor Function in Individuals With Amyotrophic Lateral Sclerosis | A Clinical Investigation of the Safety and Efficacy of Clenbuterol on Motor Function in Individuals With Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis | Drug: Clenbuterol | Dwight Koeberl, M.D., Ph.D. | NULL | Completed | 18 Years | N/A | All | 25 | Phase 2 | United States |
| 184 | EUCTR2018-004180-31-FR (EUCTR) | 31/01/2020 | 07/11/2019 | An open label extension for patients completing study 3119002 to study the effects of oral Levosimendan on breathing function in patients with the disease Amyotrophic Lateral Sclerosis (ALS) | Effects of oral Levosimendan (ODM-109) on respiratory function in patients with ALS: open label extension for patients completing study 3119002 - REFALS-ES | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Oral LEVOSIMENDAN Product Code: ODM-109 INN or Proposed INN: LEVOSIMENDAN | Orion Corporation | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | United States;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Canada;Belgium;Australia;Germany;Netherlands;Sweden | ||
| 185 | NCT04254913 (ClinicalTrials.gov) | January 24, 2020 | 23/1/2020 | Clinical Pharmacology Study of Oral Edaravone in Amyotrophic Lateral Sclerosis Patients With Gastrostomy | Clinical Pharmacology Study of Oral Edaravone in Amyotrophic Lateral Sclerosis Patients With Gastrostomy | Japanese Patients With ALS | Drug: MT-1186 | Mitsubishi Tanabe Pharma Corporation | NULL | Completed | 20 Years | 80 Years | All | 6 | Phase 1 | Japan |
| 186 | NCT04220021 (ClinicalTrials.gov) | January 10, 2020 | 3/1/2020 | Safety and Therapeutic Potential of the FDA-approved Drug Metformin for C9orf72 ALS/FTD | A Single-Center, Open Label Study to Assess the Safety and Tolerability of Metformin in Subjects With C9orf72 Amyotrophic Lateral Sclerosis Over 24 Weeks of Treatment | C9orf72 Amyotrophic Lateral Sclerosis (ALS);Frontotemporal Dementia | Drug: Metformin | University of Florida | NULL | Recruiting | 18 Years | 80 Years | All | 18 | Phase 2 | United States |
| 187 | NCT04952155 (ClinicalTrials.gov) | January 1, 2020 | 27/6/2021 | Low Dose IL-2 in the Treatment of Immune-associated ALS Syndrome | A Single-center, Open-label Clinical Study to Evaluate the Efficacy and Safety of Low-dose IL-2 in the Treatment of Immune-associated ALS Syndrome | Amyotrophic Lateral Sclerosis | Drug: IL-2 | Peking University Third Hospital | NULL | Recruiting | 18 Years | 70 Years | All | 13 | Phase 2 | China |
| 188 | EUCTR2017-003676-31-FR (EUCTR) | 31/12/2019 | 25/04/2018 | Inhibition of Rho Kinase (ROCK) with Fasudil as disease-modifying treatment for ALS | Inhibition of Rho Kinase (ROCK) with Fasudil as disease-modifying treatment for ALS | Amyotrophic lateral sclerosis MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Eril® INN or Proposed INN: FASUDIL HYDROCHLORIDE Other descriptive name: FASUDIL HYDROCHLORIDE | Georg-August-Universität Göttingen | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 2 | France;Germany;Switzerland | ||
| 189 | NCT04066244 (ClinicalTrials.gov) | December 30, 2019 | 21/8/2019 | Study of Safety and of the Mechanism of BLZ945 in ALS Patients | An Open-label, Adaptive Design Study in Patients With Amyotrophic Lateral Sclerosis (ALS) to Characterize Safety, Tolerability and Brain Microglia Response, as Measured by TSPO Binding, Following Multiple Doses of BLZ945 Using Positron Emission Tomography (PET) With the Radioligand [11C]-PBR28 | Amyotrophic Lateral Sclerosis | Drug: BLZ945 | Novartis Pharmaceuticals | NULL | Recruiting | 18 Years | N/A | All | 56 | Phase 2 | United States;Finland;Sweden |
| 190 | NCT04098406 (ClinicalTrials.gov) | December 19, 2019 | 19/9/2019 | Therapeutic Nanocatalysis to Slow Disease Progression of Amyotrophic Lateral Sclerosis (ALS) | A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study in Early Symptomatic Amyotrophic Lateral Sclerosis Patients on Stable Background Therapy to Assess Bioenergetic Catalysis With CNM-Au8 to Slow Disease Progression in ALS. | Amyotrophic Lateral Sclerosis | Drug: CNM-Au8;Drug: Placebo | Clene Nanomedicine | Clene Australia Pty Ltd | Completed | 30 Years | 80 Years | All | 45 | Phase 2 | Australia |
| 191 | EUCTR2018-004180-31-IE (EUCTR) | 16/12/2019 | 02/08/2019 | An open label extension for patients completing study 3119002 to study the effects of oral Levosimendan on breathing function in patients with the disease Amyotrophic Lateral Sclerosis (ALS) | Effects of oral Levosimendan (ODM-109) on respiratory function in patients with ALS: open label extension for patients completing study 3119002 - REFALS-ES | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Oral LEVOSIMENDAN Product Code: ODM-109 INN or Proposed INN: LEVOSIMENDAN | Orion Corporation | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | United States;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Canada;Belgium;Australia;Germany;Netherlands;Sweden | ||
| 192 | NCT04090684 (ClinicalTrials.gov) | December 9, 2019 | 29/8/2019 | Ciprofloxacin/Celecoxib Combination in Patients With ALS | Open Label, Off Label Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of Ciprofloxacin/Celecoxib Combination in Patients With ALS | ALS (Amyotrophic Lateral Sclerosis) | Drug: Fixed dose combination Ciprofloxacin/Celecoxib | NeuroSense Therapeutics Ltd. | NULL | Completed | 18 Years | 75 Years | All | 10 | Phase 1 | United States |
| 193 | NCT03377309 (ClinicalTrials.gov) | December 1, 2019 | 14/12/2017 | Safety and Tolerability of Perampanel in Amyotrophic Lateral Sclerosis Patients | Safety and Tolerability of Perampanel in Amyotrophic Lateral Sclerosis Patients | Amyotrophic Lateral Sclerosis | Drug: Fycompa | American University of Beirut Medical Center | NULL | Terminated | 18 Years | 80 Years | All | 6 | Phase 2 | Lebanon |
| 194 | NCT04172792 (ClinicalTrials.gov) | November 26, 2019 | 19/11/2019 | Safety and Tolerability Ultra-high-caloric Food Supplements in Amyotrophic Lateral Sclerosis (ALS) | Safety and Tolerability of Fat-rich vs. Carbohydrate-rich High-caloric Food Supplements in Patients With Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis | Dietary Supplement: high-caloric fatty diet;Dietary Supplement: ultra-high-caloric fatty diet;Dietary Supplement: ultra-high-caloric carbohydrate-rich diet | Albert Christian Ludolph, Prof. | Nutritia GmbH, 91052 Erlangen, Germany | Completed | 18 Years | N/A | All | 64 | Phase 1 | Germany |
| 195 | NCT04165850 (ClinicalTrials.gov) | November 25, 2019 | 13/11/2019 | Open Label Study to Evaluate Ciprofloxacin/Celecoxib Combination in Patients With ALS | Open Label Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of Ciprofloxacin/Celecoxib Combination in Patients With ALS | Amyotrophic Lateral Sclerosis;ALS | Drug: Fixed dose combination Ciprofloxacin/Celecoxib | NeuroSense Therapeutics Ltd. | NULL | Completed | 18 Years | 75 Years | All | 16 | Phase 2 | Israel |
| 196 | EUCTR2018-002722-22-NL (EUCTR) | 21/11/2019 | 06/06/2019 | Safety and efficacy of tauroursodeoxycholic acid (TUDCA) as add-ontreatment in patients affected by amyotrophic lateral sclerosis (ALS) | Safety and efficacy of tauroursodeoxycholic acid (TUDCA) as add-on treatment in patients affected by amyotrophic lateral sclerosis (ALS) - TUDCA-ALS | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: TUDCABIL INN or Proposed INN: tauroursodeoxycholic acid Other descriptive name: TAUROURSODEOXYCHOLIC ACID | Humanitas Mirasole SpA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 440 | Phase 3 | Belgium;Germany;Netherlands;Italy;United Kingdom | ||
| 197 | EUCTR2019-000826-22-FI (EUCTR) | 05/11/2019 | 18/09/2019 | Study of safety and of the mechanism of BLZ945 in amyotrophic lateral sclerosis (ALS) patients. | An open-label, adaptive design study in patients with amyotrophic lateral sclerosis (ALS) to characterize safety, tolerability and brain microglia response, as measured by TSPO binding, following multiple doses of BLZ945 using positron emission tomography (PET) with the radioligand [11C]-PBR28 | Amyotrophic lateral sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: BLZ945 INN or Proposed INN: Not yet defined Other descriptive name: BLZ945 Product Code: BLZ945 INN or Proposed INN: Not yet defined Other descriptive name: BLZ945 | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Phase 2 | United States;Finland;Sweden | ||
| 198 | EUCTR2019-002302-46-ES (EUCTR) | 23/10/2019 | 09/08/2019 | Phase II clinical trial of intramuscular infusion of autologous bone marrow stem cells in patients with amyotrophic lateral sclerosis | Phase II clinical trial of intramuscular infusion of autologous bone marrow stem cells in patients with amyotrophic lateral sclerosis | Amyotrophic Lateral Sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: autologous adult bone marrow mononuclear cells (BM-MNC) unexpanded INN or Proposed INN: autologous adult bone marrow mononuclear cells unexpanded Other descriptive name: autologous adult bone marrow mononuclear cells unexpanded | Fundación para la Formación e Investigación Sanitarias de la Región de Murcia | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Spain | ||
| 199 | NCT04259255 (ClinicalTrials.gov) | October 21, 2019 | 27/1/2020 | Radicava® (Edaravone) Findings in Biomarkers From ALS (REFINE-ALS) | Radicava® (Edaravone) Findings in Biomarkers From ALS (REFINE-ALS) | Amyotrophic Lateral Sclerosis;ALS | Drug: Edaravone (Radicava®/Radicava ORS®) | Mitsubishi Tanabe Pharma America Inc. | Massachusetts General Hospital | Recruiting | 18 Years | N/A | All | 300 | United States;Canada | |
| 200 | NCT04309604 (ClinicalTrials.gov) | October 18, 2019 | 12/3/2020 | IC14 for ALS Patients Expanded Access | IC14 for ALS Patients Expanded Access | Amyotrophic Lateral Sclerosis | Biological: IC14 | Implicit Bioscience | Massachusetts General Hospital | No longer available | 18 Years | N/A | All | United States | ||
| 201 | NCT03981536 (ClinicalTrials.gov) | October 10, 2019 | 30/5/2019 | A Study to Evaluate AP-101 in Familial and Sporadic Amyotrophic Lateral Sclerosis (ALS) | A Multicenter, Open Label, Single-Ascending Dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of AP-101 in Familial and Sporadic Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis | Drug: AP-101 | AL-S Pharma | NULL | Active, not recruiting | 18 Years | N/A | All | 18 | Phase 1 | Canada |
| 202 | ChiCTR2000035966 | 2019-10-10 | 2020-08-20 | Clinical efficacy of expanded autologous regulatory T cells infusion in amyotrophic lateral sclerosis | Clinical efficacy and safety of expanded autologous peripheral blood mononuclear cells in amyotrophic lateral sclerosis | Amyotrophic lateral sclerosis | Case series:T cell therapy + Herb Qu + Interleukin-2; | Nanjing Hospital Affiliated to Nanjing University of traditional Chinese Medicine | NULL | Recruiting | Both | Case series:30; | China | |||
| 203 | EUCTR2019-000374-39-DE (EUCTR) | 04/10/2019 | 28/05/2019 | Extension study of Arimoclomol in patients with amyotrophic lateral sclerosis. | Open-label, Non-randomised Extension Trial to Assess the Long-Term Safety and Efficacy of 1200 mg/day Arimoclomol 400 mg Three Times a Day (t.i.d.) in Subjects with Amyotrophic Lateral Sclerosis (ALS) who have Completed the ORARIALS-01 Trial | Amyotrophic Lateral Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Arimoclomol Product Code: BRX-345 INN or Proposed INN: ARIMOCLOMOL | Orphazyme A/S | NULL | Not Recruiting | Female: yes Male: yes | 231 | Phase 3 | United States;Spain;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Poland;Denmark;Germany;Netherlands;Sweden | ||
| 204 | EUCTR2018-004180-31-NL (EUCTR) | 02/10/2019 | 23/07/2019 | An open label extension for patients completing study 3119002 to study the effects of oral Levosimendan on breathing function in patients with the disease Amyotrophic Lateral Sclerosis (ALS) | Effects of oral Levosimendan (ODM-109) on respiratory function in patients with ALS: open label extension for patients completing study 3119002 - REFALS-ES | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Oral LEVOSIMENDAN Product Code: ODM-109 INN or Proposed INN: LEVOSIMENDAN | Orion Corporation | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | United States;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Canada;Belgium;Australia;Netherlands;Germany;Sweden | ||
| 205 | NCT04082832 (ClinicalTrials.gov) | September 30, 2019 | 2/9/2019 | CuATSM Compared With Placebo for Treatment of ALS/MND | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Study of Cu(II)ATSM in Patients With Amyotrophic Lateral Sclerosis/Motor Neuron Disease | Amyotrophic Lateral Sclerosis | Drug: Cu(II)ATSM;Drug: Placebos | Collaborative Medicinal Development Pty Limited | NULL | Recruiting | 18 Years | 75 Years | All | 80 | Phase 2/Phase 3 | Australia |
| 206 | EUCTR2019-000374-39-SE (EUCTR) | 26/09/2019 | 16/05/2019 | Extension study of Arimoclomol in patients with amyotrophic lateral sclerosis. | Open-label, Non-randomised Extension Trial to Assess the Long-Term Safety and Efficacy of 1200 mg/day Arimoclomol 400 mg Three Times a Day (t.i.d.) in Subjects with Amyotrophic Lateral Sclerosis (ALS) who have Completed the ORARIALS-01 Trial | Amyotrophic Lateral Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Arimoclomol Product Code: BRX-345 INN or Proposed INN: ARIMOCLOMOL | Orphazyme A/S | NULL | Not Recruiting | Female: yes Male: yes | 231 | Phase 3 | United States;Spain;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Poland;Denmark;Germany;Netherlands;Sweden | ||
| 207 | NCT03836716 (ClinicalTrials.gov) | September 19, 2019 | 7/2/2019 | Arimoclomol in Amyotropic Lateral Sclerosis - Open Label Extension Trial | Open Label, Non-randomized Extension Trial to Assess Long Term Safety and Efficacy of Arimoclomol in Subjects With Amyotropic Lateral Sclerosis Who Have Completed the ORARIALS-01 Trial | Amyotrophic Lateral Sclerosis | Drug: Arimoclomol | Orphazyme | NULL | Terminated | 18 Years | N/A | All | 120 | Phase 3 | United States;Belgium;Canada;France;Germany;Italy;Netherlands;Poland;Spain;Sweden;United Kingdom;Switzerland |
| 208 | EUCTR2019-000826-22-SE (EUCTR) | 17/09/2019 | 02/08/2019 | Study of safety and of the mechanism of BLZ945 in amyotrophic lateral sclerosis (ALS) patients. | An open-label, adaptive design study in patients with amyotrophic lateral sclerosis (ALS) to characterize safety, tolerability and brain microglia response, as measured by TSPO binding, following multiple doses of BLZ945 using positron emission tomography (PET) with the radioligand [11C]-PBR28 | Amyotrophic lateral sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: BLZ945 INN or Proposed INN: Not yet defined Other descriptive name: BLZ945 Product Code: BLZ945 INN or Proposed INN: Not yet defined Other descriptive name: BLZ945 | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Phase 2 | United States;Finland;Sweden | ||
| 209 | EUCTR2019-000374-39-PL (EUCTR) | 05/09/2019 | 22/05/2019 | Extension study of Arimoclomol in patients with amyotrophic lateral sclerosis. | Open-label, Non-randomised Extension Trial to Assess the Long-Term Safety and Efficacy of 1200 mg/day Arimoclomol 400 mg Three Times a Day (t.i.d.) in Subjects with Amyotrophic Lateral Sclerosis (ALS) who have Completed the ORARIALS-01 Trial | Amyotrophic Lateral Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Arimoclomol Product Code: BRX-345 INN or Proposed INN: ARIMOCLOMOL | Orphazyme A/S | NULL | Not Recruiting | Female: yes Male: yes | 231 | Phase 3 | United States;Spain;Italy;Switzerland;United Kingdom;France;Canada;Poland;Belgium;Denmark;Germany;Netherlands;Sweden | ||
| 210 | EUCTR2018-004180-31-GB (EUCTR) | 05/09/2019 | 01/11/2019 | An open label extension for patients completing study 3119002 to studythe effects of oral Levosimendan on breathing function in patients with thedisease Amyotrophic Lateral Sclerosis (ALS) | Effects of oral levosimendan (ODM-109) on respiratory function in patients with ALS: open label extension for patients completing study 3119002 - REFALS-ES | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Oral LEVOSIMENDAN Product Code: ODM-109 INN or Proposed INN: LEVOSIMENDAN | Orion Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | United States;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Canada;Belgium;Australia;Netherlands;Germany;Sweden | ||
| 211 | NCT03474263 (ClinicalTrials.gov) | September 1, 2019 | 9/3/2018 | IC14 for Rapidly Progressive Amyotrophic Lateral Sclerosis (ALS) | A Phase 2a, Open-Label Biomarker Study of IC14 for the Treatment of Patients With | Amyotrophic Lateral Sclerosis | Biological: Biologic: IC14 (monoclonal antibody against human CD14) | Implicit Bioscience | NULL | Withdrawn | 18 Years | 80 Years | All | 0 | Phase 2 | Australia;United States |
| 212 | NCT04081714 (ClinicalTrials.gov) | August 31, 2019 | 5/9/2019 | Intermediate Expanded Access Protocol for ALS | An Intermediate Expanded Access Protocol for Amyotrophic Lateral Sclerosis With CNM-Au8 | Amyotrophic Lateral Sclerosis | Drug: CNM-Au8 | Clene Nanomedicine | Massachusetts General Hospital | Available | 18 Years | N/A | All | United States | ||
| 213 | EUCTR2019-000374-39-NL (EUCTR) | 27/08/2019 | 29/05/2019 | Extension study of Arimoclomol in patients with amyotrophic lateral sclerosis. | Open-label, Non-randomised Extension Trial to Assess the Long-Term Safety and Efficacy of 1200 mg/day Arimoclomol 400 mg Three Times a Day (t.i.d.) in Subjects with Amyotrophic Lateral Sclerosis (ALS) who have Completed the ORARIALS-01 Trial | Amyotrophic Lateral Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Arimoclomol Product Code: BRX-345 INN or Proposed INN: ARIMOCLOMOL | Orphazyme A/S | NULL | Not Recruiting | Female: yes Male: yes | 231 | Phase 3 | United States;Spain;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Poland;Denmark;Netherlands;Germany;Sweden | ||
| 214 | EUCTR2018-004180-31-AT (EUCTR) | 22/08/2019 | 03/05/2019 | An open label extension for patients completing study 3119002 to study the effects of oral Levosimendan on breathing function in patients with the disease Amyotrophic Lateral Sclerosis (ALS) | Effects of oral Levosimendan (ODM-109) on respiratory function in patients with ALS: open label extension for patients completing study 3119002 - REFALS-ES | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Oral LEVOSIMENDAN Product Code: ODM-109 INN or Proposed INN: LEVOSIMENDAN | Orion Corporation | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | United States;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Canada;Belgium;Australia;Germany;Netherlands;Sweden | ||
| 215 | NCT03508453 (ClinicalTrials.gov) | August 15, 2019 | 16/4/2018 | IC14 for Treatment of Amyotrophic Lateral Sclerosis | A Phase 2, Randomised, Double-Blind, Placebo-Controlled Study of IC14 for Treatment of Patients With Rapidly Progressive Motor Neuron Disease | Amyotrophic Lateral Sclerosis;Motor Neuron Disease | Biological: IC14;Other: Placebo | Implicit Bioscience | NULL | Withdrawn | 18 Years | 75 Years | All | 0 | Phase 2 | Australia |
| 216 | EUCTR2018-004180-31-FI (EUCTR) | 15/08/2019 | 25/04/2019 | An open label extension for patients completing study 3119002 to study the effects of oral Levosimendan on breathing function in patients with the disease Amyotrophic Lateral Sclerosis (ALS) | Effects of oral Levosimendan (ODM-109) on respiratory function in patients with ALS: open label extension for patients completing study 3119002 - REFALS-ES | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Oral LEVOSIMENDAN Product Code: ODM-109 INN or Proposed INN: LEVOSIMENDAN | Orion Corporation | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | United States;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Canada;Belgium;Australia;Germany;Netherlands;Sweden | ||
| 217 | EUCTR2019-000374-39-ES (EUCTR) | 07/08/2019 | 11/06/2019 | Extension study of Arimoclomol in patients with amyotrophic lateral sclerosis. | Open-label, Non-randomised Extension Trial to Assess the Long-Term Safety and Efficacy of 1200 mg/day Arimoclomol 400 mg Three Times a Day (t.i.d.) in Subjects with Amyotrophic Lateral Sclerosis (ALS) who have Completed the ORARIALS-01 Trial | Amyotrophic Lateral Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Arimoclomol Product Code: BRX-345 INN or Proposed INN: ARIMOCLOMOL | Orphazyme A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 231 | Phase 3 | United States;Spain;Switzerland;United Kingdom;Italy;France;Canada;Belgium;Poland;Denmark;Germany;Netherlands;Sweden | ||
| 218 | NCT04055623 (ClinicalTrials.gov) | August 7, 2019 | 12/8/2019 | T-regulatory Cells in ALS | Phase 2a Study of the Expansion and Infusion of Autologous T-Regulatory Cells in Amyotrophic Lateral Sclerosis | ALS (Amyotrophic Lateral Sclerosis) | Biological: Monthly autologous Treg cells infusions + 3 times per week Interleukin-2 injections;Other: Monthly placebo infusions + 3 times per week placebo injections | The Methodist Hospital Research Institute | Massachusetts General Hospital;The Center for Clinical and Translational Sciences (CCTS) Clinical Research Unit at The University of Texas Health Science Center at Houston;North East Amyotrophic Lateral Sclerosis Consortium | Active, not recruiting | 18 Years | N/A | All | 12 | Phase 2 | United States |
| 219 | NCT03883581 (ClinicalTrials.gov) | July 25, 2019 | 12/3/2019 | Impact of Nuedexta on Bulbar Physiology and Function in ALS | Impact of Nuedexta on Bulbar Physiology and Function in ALS | Amyotrophic Lateral Sclerosis | Drug: dextromethorphan HBr and quinidine sulfate | University of Florida | Holy Cross Hospital, Florida;ALS Association | Completed | 18 Years | 90 Years | All | 28 | Phase 1/Phase 2 | United States |
| 220 | EUCTR2018-004180-31-IT (EUCTR) | 24/07/2019 | 18/01/2021 | An open label extension for patients completing study 3119002 to study the effects of oral Levosimendan on breathing function in patients with the disease Amyotrophic Lateral Sclerosis (ALS) | Effects of oral Levosimendan (ODM-109) on respiratory function in patients with ALS: open label extension for patients completing study 3119002 - REFALS-ES | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Oral LEVOSIMENDAN Product Code: [ODM-109] INN or Proposed INN: LEVOSIMENDAN | ORION CORPORATION ORION PHARMA | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | United States;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Canada;Belgium;Australia;Germany;Netherlands;Sweden | ||
| 221 | ChiCTR1900024520 | 2019-07-22 | 2019-07-13 | Split-hand index calculated by F-wave test apply to the diagnosis of amyotrophic lateral sclerosis | Split-hand index calculated by F-wave test apply to the diagnosis of amyotrophic lateral sclerosis | Amyotrophic lateral sclerosis | Gold Standard:Clinical outcome meet the Awaji-Shima Criteria 2008;Index test:Split-hand index calculated by F-wave test; | Peking Union Medical College Hospita | NULL | Recruiting | 18 | 80 | Both | Target condition:300;Difficult condition:50 | N/A | China |
| 222 | EUCTR2019-000374-39-GB (EUCTR) | 15/07/2019 | 09/05/2019 | Extension study of Arimoclomol in patients with amyotrophic lateral sclerosis. | Open-label, Non-randomised Extension Trial to Assess the Long-Term Safety and Efficacy of 1200 mg/day Arimoclomol 400 mg Three Times a Day (t.i.d.) in Subjects with Amyotrophic Lateral Sclerosis (ALS) who have Completed the ORARIALS-01 Trial | Amyotrophic Lateral Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Arimoclomol Product Code: BRX-345 INN or Proposed INN: ARIMOCLOMOL | Orphazyme A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 231 | Phase 3 | United States;Spain;United Kingdom;Italy;Switzerland;France;Canada;Belgium;Poland;Denmark;Germany;Netherlands;Sweden | ||
| 223 | EUCTR2019-000374-39-IT (EUCTR) | 15/07/2019 | 27/01/2021 | Extension study of Arimoclomol in patients with amyotrophic lateral sclerosis. | Open-label, Non-randomised Extension Trial to Assess the Long-Term Safety and Efficacy of 1200 mg/day Arimoclomol 400 mg Three Times a Day (t.i.d.) in Subjects with Amyotrophic Lateral Sclerosis (ALS) who have Completed the ORARIALS-01 Trial - na | Amyotrophic Lateral Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Arimoclomol Product Code: [BRX-345] INN or Proposed INN: ARIMOCLOMOL | ORPHAZYME APS | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 231 | Phase 3 | United States;Spain;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Poland;Denmark;Germany;Netherlands;Sweden | ||
| 224 | NCT03948178 (ClinicalTrials.gov) | June 26, 2019 | 7/5/2019 | Effects of Oral Levosimendan on Respiratory Function in Patients With ALS: Open-Label Extension | Effects of Oral Levosimendan (ODM-109) on Respiratory Function in Patients With ALS: Open-Label Extension for Patients Completing Study 3119002 | Amyotrophic Lateral Sclerosis | Drug: Levosimendan | Orion Corporation, Orion Pharma | NULL | Completed | 18 Years | 120 Years | All | 227 | Phase 3 | Spain |
| 225 | EUCTR2018-004180-31-DE (EUCTR) | 17/06/2019 | 12/04/2019 | An open label extension for patients completing study 3119002 to study the effects of oral Levosimendan on breathing function in patients with the disease Amyotrophic Lateral Sclerosis (ALS) | Effects of oral Levosimendan (ODM-109) on respiratory function in patients with ALS: open label extension for patients completing study 3119002 - REFALS-ES | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Oral LEVOSIMENDAN Product Code: ODM-109 INN or Proposed INN: LEVOSIMENDAN | Orion Corporation | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | United States;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Canada;Belgium;Australia;Germany;Netherlands;Sweden | ||
| 226 | NCT04140136 (ClinicalTrials.gov) | June 17, 2019 | 21/10/2019 | The Efficacy and Safety of Vitamin E Mixed Tocotrienols In Patients With Amyotrophic Lateral Sclerosis (ALS) | The Efficacy and Safety of Vitamin E Mixed Tocotrienols In Patients With Amyotrophic Lateral Sclerosis (ALS) : A Pilot Exploratory Study | Amyotrophic Lateral Sclerosis | Dietary Supplement: Tocotrienols;Dietary Supplement: Placebo | University of Malaya | NULL | Recruiting | N/A | N/A | All | 20 | Phase 2 | Malaysia |
| 227 | EUCTR2018-002722-22-BE (EUCTR) | 06/06/2019 | 19/02/2019 | Safety and efficacy of tauroursodeoxycholic acid (TUDCA) as add-ontreatment in patients affected by amyotrophic lateral sclerosis (ALS) | Safety and efficacy of tauroursodeoxycholic acid (TUDCA) as add-ontreatment in patients affected by amyotrophic lateral sclerosis (ALS) - TUDCA-ALS | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: TUDCABIL INN or Proposed INN: tauroursodeoxycholic acid Other descriptive name: TAUROURSODEOXYCHOLIC ACID | Humanitas Mirasole SpA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 320 | Phase 3 | Belgium;Netherlands;Germany;Italy;United Kingdom | ||
| 228 | EUCTR2018-002722-22-DE (EUCTR) | 03/06/2019 | 05/02/2019 | Safety and efficacy of a treatment with tauroursodeoxycholic acid (TUDCA) on top of riluzole in patients affected by amyotrophic lateral sclerosis (ALS) | Safety and efficacy of tauroursodeoxycholic acid (TUDCA) as add-on treatment in patients affected by amyotrophic lateral sclerosis (ALS) - TUDCA-ALS | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: TUDCABIL INN or Proposed INN: tauroursodeoxycholic acid Other descriptive name: TAUROURSODEOXYCHOLIC ACID | Humanitas Mirasole SpA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 320 | Phase 3 | Belgium;Netherlands;Germany;Italy;United Kingdom | ||
| 229 | NCT03945279 (ClinicalTrials.gov) | May 30, 2019 | 8/5/2019 | A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB100 Administered Orally to Adults With Amyotrophic Lateral Sclerosis | A Phase 1, Double-Blind, Placebo-Controlled, Single-Ascending-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB100 Administered Orally to Adult Participants With Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis | Drug: BIIB100;Drug: Placebo | Biogen | NULL | Completed | 18 Years | N/A | All | 49 | Phase 1 | United States |
| 230 | EUCTR2018-002722-22-GB (EUCTR) | 20/05/2019 | 28/02/2019 | Safety and efficacy of tauroursodeoxycholic acid (TUDCA) as add-on treatment in patients affected by amyotrophic lateral sclerosis (ALS) | Safety and efficacy of tauroursodeoxycholic acid (TUDCA) as add-on treatment in patients affected by amyotrophic lateral sclerosis (ALS) - TUDCA-ALS | amyotrophic lateral sclerosis MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Taurolite Product Name: Taurolite INN or Proposed INN: Tauroursodeoxycholic acid | IRCCS ISTITUTO CLINICO HUMANITAS | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 440 | Phase 3 | Netherlands;United Kingdom | ||
| 231 | EUCTR2018-004180-31-ES (EUCTR) | 16/05/2019 | 12/04/2019 | An open label extension for patients completing study 3119002 to study the effects of oral Levosimendan on breathing function in patients with the disease Amyotrophic Lateral Sclerosis (ALS) | Effects of oral Levosimendan (ODM-109) on respiratory function in patients with ALS: open label extension for patients completing study 3119002 - REFALS-ES | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 20.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Oral LEVOSIMENDAN Product Code: ODM-109 INN or Proposed INN: LEVOSIMENDAN | Orion Corporation | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | United States;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Canada;Belgium;Australia;Germany;Netherlands;Sweden | ||
| 232 | EUCTR2018-004180-31-BE (EUCTR) | 29/04/2019 | 15/03/2019 | An open label extension for patients completing study 3119002 to study the effects of oral Levosimendan on breathing function in patients with the disease Amyotrophic Lateral Sclerosis (ALS) | Effects of oral Levosimendan (ODM-109) on respiratory function in patients with ALS: open label extension for patients completing study 3119002 - REFALS-ES | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Oral LEVOSIMENDAN Product Code: ODM-109 INN or Proposed INN: LEVOSIMENDAN | Orion Corporation | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | United States;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Canada;Belgium;Australia;Germany;Netherlands;Sweden | ||
| 233 | NCT04176224 (ClinicalTrials.gov) | April 17, 2019 | 22/11/2019 | Clinical Pharmacology Study of Oral Edaravone in Patients With Amyotrophic Lateral Sclerosis | Clinical Pharmacology Study of Oral Edaravone in Patients With Amyotrophic Lateral Sclerosis (ALS) | Japanese Patients With ALS | Drug: MT-1186 | Mitsubishi Tanabe Pharma Corporation | NULL | Completed | 20 Years | 75 Years | All | 9 | Phase 1 | Japan |
| 234 | NCT03693781 (ClinicalTrials.gov) | April 10, 2019 | 30/9/2018 | Colchicine for Amyotrophic Lateral Sclerosis | Colchicine for Amyotrophic Lateral Sclerosis: a Phase II, Randomized, Double Blind, Placebo Controlled, Multicenter Clinical Trial | Amyotrophic Lateral Sclerosis | Drug: Colchicine 1 MG Oral Tablet;Drug: Placebo Oral Tablet | Azienda Ospedaliero-Universitaria di Modena | University of Modena and Reggio Emilia;University of Turin, Italy;Istituto Auxologico Italiano;IRCCS National Neurological Institute C. Mondino Foundation;University of Bari;IRCCS San Raffaele;University of Padova;University of Milan;Istituto Di Ricerche Farmacologiche Mario Negri;University of Campania Luigi Vanvitelli;Catholic University of the Sacred Heart | Completed | 18 Years | 80 Years | All | 54 | Phase 2 | Italy |
| 235 | NCT02437110 (ClinicalTrials.gov) | April 1, 2019 | 5/5/2015 | HERV-K Suppression Using Antiretroviral Therapy in Volunteers With Amyotrophic Lateral Sclerosis (ALS) | HERV-K Suppression Using Antiretroviral Therapy in Volunteers With Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis | Drug: Darunavir;Drug: Ritonavir;Drug: Dolutegravir;Drug: Tenofovir alafenamide (TAF) | National Institute of Neurological Disorders and Stroke (NINDS) | NULL | Active, not recruiting | 18 Years | N/A | All | 122 | Phase 1 | United States |
| 236 | JPRN-jRCT2051190001 | 29/03/2019 | 01/04/2019 | Phase 1 Dose Escalation Study of Bosutinib in Patients with Amyotrophic Lateral Sclerosis (ALS) | Phase 1 Dose Escalation Study of Bosutinib in Patients with Amyotrophic Lateral Sclerosis (ALS) - Phase 1 Dose Escalation Study of Bosutinib in Patients with Amyotrophic Lateral Sclerosis (ALS) | amyotrophic lateral sclerosis ALS | The study consists of a 12-week observation period, a 1-week (5- to 9-day) transitional period, a 12-week study treatment period, and a 4-week follow-up period. 3 to 6 ALS patients will be enrolled in each of the 4 bosutinib dose levels [100 mg/day (dose level 1), 200 mg/day (dose level 2), 300 mg/day (dose level 3), or 400mg/day (dose level 4)] to evaluate the safety and tolerability of the investigational drug (bosutinib) under a 3+3 dose escalation study design. | Inoue Haruhisa | NULL | Recruiting | 20age | 79age | Both | 24 | Phase 1 | Japan |
| 237 | NCT03705390 (ClinicalTrials.gov) | March 29, 2019 | 11/9/2018 | A Safety and Tolerability Study of ILB in Patients With Amyothrophic Lateral Sclerosis (ALS) | A Phase II Pilot Single-arm Safety and Tolerability Study of ILB in Patients With Motor Neurone Disease (MND)/ Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis;Motor Neuron Disease | Drug: ILB | University of Birmingham | TikoMed AB;University Hospital Birmingham;Neuregenix | Completed | 18 Years | N/A | All | 11 | Phase 2 | United Kingdom |
| 238 | JPRN-UMIN000036295 | 2019/03/29 | 26/03/2019 | Phase 1 Dose Escalation Study of Bosutinib in Patients with Amyotrophic Lateral Sclerosis (ALS) | Phase 1 Dose Escalation Study of Bosutinib in Patients with Amyotrophic Lateral Sclerosis (ALS) - Phase 1 Dose Escalation Study of Bosutinib in Patients with Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis | The study consists of a 12-week observation period, a 1-week (5- to 9-day) transitional period, a 12-week study treatment period, and a 4-week follow-up period. 3 to 6 ALS patients will be enrolled in each of the 4 bosutinib dose levels [100 mg/day (dose level 1), 200 mg/day (dose level 2), 300 mg/day (dose level 3), or 400mg/day (dose level 4)] to evaluate the safety and tolerability of the investigational drug (bosutinib) under a 3+3 dose escalation study design. | Center for iPS Cell Research and Application, Kyoto University | Provider of the investigational product: Pfizer Japan Inc. | Complete: follow-up complete | 20years-old | 80years-old | Male and Female | 24 | Phase 1 | Japan |
| 239 | JPRN-JMA-IIA00419 | 29/03/2019 | 29/03/2019 | Phase 1 dose-escalation study of bosutinib in patients with amyotrophic lateral sclerosis (ALS) | Phase 1 dose-escalation study of bosutinib in patients with amyotrophic lateral sclerosis (ALS) | Amyotrophic Lateral Sclerosis | Intervention type:DRUG. Intervention1:Medicine, Dose form:TABLET, Route of administration:ORAL, intended dose regimen:The study consists of a 12-week observation period, a 1-week (5- to 9-day) transitional period, a 12-week study treatment period, and a 4-week follow-up period. . | Center for iPS Cell Research and Application (CiRA), Kyoto University | NULL | Recruiting | >=20 YEARS | <80 YEARS | BOTH | 24 | Phase 1 | Japan |
| 240 | EUCTR2017-002754-36-FR (EUCTR) | 27/03/2019 | 27/11/2018 | Effects of oral levosimendan on breathing function in patients with the disease Amyotrophic Lateral Sclerosis (ALS) | Effects of oral levosimendan (ODM-109) on respiratory function in patients with ALS - REFALS | Amyotrophic lateral sclerosis (ALS) MedDRA version: 20.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Oral LEVOSIMENDAN Product Code: ODM-109 INN or Proposed INN: LEVOSIMENDAN | Orion Corporation | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | United States;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Canada;Belgium;Australia;Germany;Netherlands;Sweden | ||
| 241 | NCT04744532 (ClinicalTrials.gov) | March 19, 2019 | 9/1/2021 | iPSC-based Drug Repurposing for ALS Medicine (iDReAM) Study | Phase 1/2 Study of Bosutinib in Patients With Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis | Drug: Bosutinib (Phase 1 part);Drug: Bosutinib (Phase 2 part) | Kyoto University | Tokushima University;Kitasato University;Tottori University;Nara Medical University;Toho University;Hiroshima University;Pfizer | Recruiting | 20 Years | 75 Years | All | 49 | Phase 1/Phase 2 | Japan |
| 242 | NCT03800524 (ClinicalTrials.gov) | February 22, 2019 | 4/1/2019 | Safety and Efficacy of TUDCA as add-on Treatment in Patients Affected by ALS | Safety and Efficacy of Tauroursodeoxycholic (TUDCA) as add-on Treatment in Patients Affected by Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis (ALS) | Drug: Tauroursodeoxycholic Acid;Drug: Placebo | Humanitas Mirasole SpA | University of Ulm;University of Sheffield;University Hospital, Tours;KU Leuven;UMC Utrecht;University of Dublin, Trinity College;Bruschettini S.r.l.;Istituto Superiore di Sanità;Motor Neurone Disease Association;European Commission | Active, not recruiting | 18 Years | 80 Years | All | 337 | Phase 3 | Belgium;France;Germany;Ireland;Italy;Netherlands;United Kingdom |
| 243 | NCT03792490 (ClinicalTrials.gov) | February 20, 2019 | 28/12/2018 | Inhibition of Rho Kinase (ROCK) With Fasudil as Disease-modifying Treatment for ALS | Inhibition of Rho Kinase (ROCK) With Fasudil as Disease-modifying Treatment for ALS | Amyotrophic Lateral Sclerosis | Drug: Fasudil;Drug: Placebo | University Medical Center Goettingen | NULL | Active, not recruiting | 18 Years | N/A | All | 120 | Phase 2 | France;Germany;Switzerland |
| 244 | NCT03690791 (ClinicalTrials.gov) | January 9, 2019 | 13/9/2018 | Efficacy of Cannabinoids in Amyotrophic Lateral Sclerosis or Motor Neurone Disease | A Randomised, Double-blind, Single-centre Study on the Safety, Tolerability and Efficacy of Cannabis Based Medicine Extract (MediCabilis CBD Oil) in Slowing the Disease Progression in Amyotrophic Lateral Sclerosis or Motor Neurone Disease Patients | Amyotrophic Lateral Sclerosis;Motor Neuron Disease | Drug: MediCabilis CBD Oil;Drug: Placebo Oil | Gold Coast Hospital and Health Service | BOD Australia | Recruiting | 25 Years | 80 Years | All | 30 | Phase 3 | Australia |
| 245 | NCT03293069 (ClinicalTrials.gov) | January 1, 2019 | 21/9/2017 | Conservative Iron Chelation as a Disease-modifying Strategy in Amyotrophic Lateral Sclerosis | Conservative Iron Chelation as a Disease-modifying Strategy in Amyotrophic Lateral Sclerosis: Multicentre, Parallel-group, Placebo-controlled, Randomized Clinical Trial of Deferiprone | Amyotrophic Lateral Sclerosis | Drug: Deferiprone;Drug: Placebo Oral Tablet | University Hospital, Lille | Ministry of Health, France | Active, not recruiting | 18 Years | 75 Years | All | 372 | Phase 2/Phase 3 | France |
| 246 | EUCTR2018-002722-22-IT (EUCTR) | 18/12/2018 | 18/01/2021 | Safety and efficacy of tauroursodeoxycholic acid (TUDCA) as add-on treatment in patients affected by amyotrophic lateral sclerosis (ALS) | Safety and efficacy of tauroursodeoxycholic acid (TUDCA) as add-on treatment in patients affected by amyotrophic lateral sclerosis (ALS) - TUDCA-ALS | amyotrophic lateral sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: TUDCABIL Product Name: TUDCABIL Product Code: [TUDCA] INN or Proposed INN: ACIDO TAUROURSODESOSSICOLICO | IRCCS ISTITUTO CLINICO HUMANITAS | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 440 | Phase 3 | France;Belgium;Ireland;Netherlands;Germany;United Kingdom;Italy | ||
| 247 | NCT03757351 (ClinicalTrials.gov) | December 14, 2018 | 27/11/2018 | Study to Evaluate DNL747 in Subjects With Amyotrophic Lateral Sclerosis | A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Phase 1b Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL747 in Subjects With Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis | Drug: DNL747;Drug: Placebo | Sanofi | Denali Therapeutics Inc. | Terminated | 21 Years | 80 Years | All | 15 | Phase 1 | United States;Netherlands |
| 248 | NCT03755167 (ClinicalTrials.gov) | December 9, 2018 | 21/11/2018 | A Follow up Study to Protocol 101/2 - Continued Treatment by IPL344 IV | An Open-Label, Multi-Center, Follow up Study to Protocol 101/2 - Continued Treatment by Intravenously Administered IPL344 to Amyotrophic Lateral Sclerosis (ALS) Patients | Amyotrophic Lateral Sclerosis (ALS) | Drug: IPL344 | Immunity Pharma Ltd. | NULL | Recruiting | 18 Years | 75 Years | All | 15 | Phase 2 | Israel |
| 249 | JPRN-JMA-IIA00397 | 05/12/2018 | 26/11/2018 | Phase 1/2a Study of Ropinirole Hydrochloride Extended-Release Tablets in Patients with Amyotrophic Lateral Sclerosis (ALS) | Phase 1/2a, Double-blind, Placebo-controlled Study with an Open-label Extension of Ropinirole Hydrochloride Extended-Release Tablets-Explorative Assessment of the Safety, Tolerability, and Efficacy after Oral Treatment in Patients with Amyotrophic Lateral Sclerosis (ALS)- | amyotrophic lateral sclerosis (ALS) | Intervention type:DRUG. Intervention1:Requip CR tablets, Dose form:SUSTAINED-RELEASE TABLET, Route of administration:ORAL, intended dose regimen:Once daily ropinirole hydrochloride extended-release tablet with dose-escalation tolerable from 2mg to 16mg for 24 weeks (Interventions). Control intervention1:Placebo, Dose form:SUSTAINED-RELEASE TABLET, Route of administration:ORAL, Intended dose regimen:Once daily placebo tablet with dose-escalation tolerable from 2mg to 16mg for 24 weeks (Interventions). | none | NULL | Completed | >=20 YEARS | <=80 YEARS | BOTH | 20 | Phase 1-2 | Japan |
| 250 | NCT03793868 (ClinicalTrials.gov) | December 4, 2018 | 28/12/2018 | Perampanel Single Ascending Dose Transcranial Magnetic Stimulation Biomarker Study in Amyotrophic Lateral Sclerosis | Perampanel Single Ascending Dose Transcranial Magnetic Stimulation Biomarker Study in Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis | Drug: Perampanel;Other: Placebo | Mayo Clinic | NULL | Completed | 18 Years | 70 Years | All | 22 | Early Phase 1 | United States |
| 251 | EUCTR2018-000137-13-BE (EUCTR) | 04/12/2018 | 13/09/2018 | A study to compare the use of Arimoclomol with placebo in patients with Amyotrophic Lateral Sclerosis | A Phase 3, Randomised, Placebo-Controlled Trial of Arimoclomol in Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Arimoclomol Product Code: BRX-345 INN or Proposed INN: ARIMOCLOMOL | Orphazyme A/S | NULL | Not Recruiting | Female: yes Male: yes | 231 | Phase 3 | United States;France;Canada;Spain;Poland;Belgium;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden | ||
| 252 | NCT03944447 (ClinicalTrials.gov) | December 1, 2018 | 3/5/2019 | Outcomes Mandate National Integration With Cannabis as Medicine | Outcomes Mandate National Integration With Cannabis as Medicine | Chronic Pain;Chronic Pain Syndrome;Chronic Pain Due to Injury;Chronic Pain Due to Trauma;Fibromyalgia;Seizures;Hepatitis C;Cancer;Crohn Disease;HIV/AIDS;Multiple Sclerosis;Traumatic Brain Injury;Sickle Cell Disease;Post Traumatic Stress Disorder;Tourette Syndrome;Ulcerative Colitis;Glaucoma;Epilepsy;Inflammatory Bowel Diseases;Parkinson Disease;Amyotrophic Lateral Sclerosis;Chronic Traumatic Encephalopathy;Anxiety;Depression;Insomnia;Autism;Opioid-use Disorder;Bipolar Disorder;Covid19;SARS-CoV Infection;COVID-19;Corona Virus Infection;Coronavirus | Drug: Cannabis, Medical;Device: RYAH-Medtech Inhaler | OMNI Medical Services, LLC | OMNI Medical Services Inc | Recruiting | 7 Years | N/A | All | 200000 | Phase 2 | United States |
| 253 | EUCTR2018-000137-13-NL (EUCTR) | 21/11/2018 | 18/09/2018 | A study to compare the use of Arimoclomol with placebo in patients with Amyotrophic Lateral Sclerosis | A Phase 3, Randomised, Placebo-Controlled Trial of Arimoclomol in Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Arimoclomol Product Code: BRX-345 INN or Proposed INN: ARIMOCLOMOL | Orphazyme A/S | NULL | Not Recruiting | Female: yes Male: yes | 231 | Phase 3 | France;United States;Canada;Spain;Poland;Belgium;Germany;Netherlands;United Kingdom;Switzerland;Italy;Sweden | ||
| 254 | EUCTR2018-000137-13-GB (EUCTR) | 19/11/2018 | 07/09/2018 | A study to compare the use of Arimoclomol with placebo in patients with Amyotrophic Lateral Sclerosis | A Phase 3, Randomised, Placebo-Controlled Trial of Arimoclomol in Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Arimoclomol Product Code: BRX-345 INN or Proposed INN: ARIMOCLOMOL | Orphazyme A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 231 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;United States;Canada;Poland;Belgium;Spain;Netherlands;Germany;Italy;Switzerland;United Kingdom;Sweden | ||
| 255 | NCT02118727 (ClinicalTrials.gov) | November 7, 2018 | 15/4/2014 | Therapy in Amyotrophic Lateral Sclerosis (TAME) | Multi-centered Double Blind, Placebo Controlled Study Evaluating the Safety and Efficacy of Memantine at 20 mg BID in Patients With ALS | Amyotrophic Lateral Sclerosis;Frontal Temporal Dementia | Drug: Memantine;Drug: Placebo (for Memantine) | University of Kansas Medical Center | University of Missouri-Columbia | Completed | 18 Years | 85 Years | All | 90 | Phase 2 | United States |
| 256 | NCT03580616 (ClinicalTrials.gov) | October 24, 2018 | 26/6/2018 | Tolerability and Efficacy of L-Serine in Patients With Amyotrophic Lateral Sclerosis (ALS) | Tolerability and Efficacy of L-Serine in Patients With Amyotrophic Lateral Sclerosis: A Phase IIa Study | Amyotrophic Lateral Sclerosis (ALS) | Drug: L-Serine | Elijah W. Stommel | Brain Chemistry Labs, Institute for Ethnomedicine | Suspended | 18 Years | N/A | All | 50 | Phase 2 | United States |
| 257 | EUCTR2018-000137-13-SE (EUCTR) | 22/10/2018 | 07/09/2018 | A study to compare the use of Arimoclomol with placebo in patients with Amyotrophic Lateral Sclerosis | A Phase 3, Randomised, Placebo-Controlled Trial of Arimoclomol in Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Arimoclomol Product Code: BRX-345 INN or Proposed INN: ARIMOCLOMOL | Orphazyme A/S | NULL | Not Recruiting | Female: yes Male: yes | 231 | Phase 3 | United States;France;Canada;Spain;Poland;Belgium;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden | ||
| 258 | EUCTR2018-000137-13-ES (EUCTR) | 19/10/2018 | 09/10/2018 | A study to compare the use of Arimoclomol with placebo in patients with Amyotrophic Lateral Sclerosis | A Phase 3, Randomised, Placebo-Controlled Trial of Arimoclomol in Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Arimoclomol Product Code: BRX-345 INN or Proposed INN: ARIMOCLOMOL | Orphazyme A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 231 | Phase 3 | France;United States;Canada;Poland;Belgium;Spain;Netherlands;Germany;Italy;United Kingdom;Switzerland;Sweden | ||
| 259 | EUCTR2018-000137-13-PL (EUCTR) | 18/10/2018 | 02/10/2018 | A study to compare the use of Arimoclomol with placebo in patients with Amyotrophic Lateral Sclerosis | A Phase 3, Randomised, Placebo-Controlled Trial of Arimoclomol in Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Arimoclomol Product Code: BRX-345 INN or Proposed INN: ARIMOCLOMOL | Orphazyme A/S | NULL | Not Recruiting | Female: yes Male: yes | 231 | Phase 3 | United States;France;Canada;Spain;Belgium;Poland;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden | ||
| 260 | EUCTR2018-000137-13-IT (EUCTR) | 08/10/2018 | 22/01/2021 | A study to compare the use of Arimoclomol with placebo in patients withAmyotrophic Lateral Sclerosis | A Phase 3, Randomised, Placebo-Controlled Trial of Arimoclomol in Amyotrophic Lateral Sclerosis - na | Amyotrophic Lateral Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Arimoclomol Product Code: [BRX-345] INN or Proposed INN: ARIMOCLOMOL | ORPHAZYME APS | NULL | Not Recruiting | Female: yes Male: yes | 231 | Phase 3 | France;United States;Canada;Spain;Poland;Belgium;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden | ||
| 261 | EUCTR2018-000137-13-FR (EUCTR) | 05/10/2018 | 06/09/2018 | A study to compare the use of Arimoclomol with placebo in patients with Amyotrophic Lateral Sclerosis | A Phase 3, Randomised, Placebo-Controlled Trial of Arimoclomol in Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Arimoclomol Product Code: BRX-345 INN or Proposed INN: ARIMOCLOMOL | Orphazyme A/S | NULL | Not Recruiting | Female: yes Male: yes | 231 | Phase 3 | United States;France;Canada;Spain;Poland;Belgium;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden | ||
| 262 | EUCTR2018-000586-37-IE (EUCTR) | 13/09/2018 | 08/05/2018 | A Study to Evaluate the Efficacy, Safety and Tolerability of CK-2127107 In Patients with Amyotrophic Lateral Sclerosis (ALS) | A Phase 2, Multi-Center, Double-Blind, Randomized, Dose-Ranging, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability Of CK-2127107 In Patients with Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 20.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Reldesemtiv Product Code: CK-2127107 INN or Proposed INN: Reldesemtiv Other descriptive name: Reldesemtiv | Cytokinetics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 445 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Canada;Spain;Ireland;Australia;Netherlands | ||
| 263 | EUCTR2017-004459-21-IT (EUCTR) | 11/09/2018 | 07/11/2018 | Study evaluating the treatment with colchicine for the amyotrophic lateral sclerosis | Colchicine for Amyotrophic Lateral Sclerosis: a phase II, randomized, double blind, placebo controlled, multicenter clinical trial - Co-ALS | Definite or probable amyotrophic lateral sclerosis MedDRA version: 20.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: LLT;Classification code 10052889;Term: ALS;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: COLCHICINA LIRCA - 1 MG COMPRESSE 60 COMPRESSE Product Name: Colchicina Product Code: Colchicina INN or Proposed INN: COLCHICINA Other descriptive name: COLCHICINA | AZIENDA OSPEDALIERO-UNIVERSITARIA POLICLINICO DI MODENA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 54 | Phase 2 | Italy | ||
| 264 | NCT03626012 (ClinicalTrials.gov) | September 10, 2018 | 7/8/2018 | A Study to Assess the Safety, Tolerability, and Pharmacokinetics of BIIB078 in Adults With C9ORF72-Associated Amyotrophic Lateral Sclerosis | A Phase 1 Multiple-Ascending-Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of BIIB078 Administered Intrathecally to Adults With C9ORF72-Associated Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis | Drug: BIIB078;Drug: Placebo | Biogen | NULL | Completed | 18 Years | N/A | All | 106 | Phase 1 | United States;Canada;Ireland;Netherlands;Switzerland;United Kingdom |
| 265 | EUCTR2016-003225-41-DE (EUCTR) | 06/09/2018 | 15/09/2017 | Long-Term Evaluation of BIIB067 | An Extension Study to Assess the Long-Term Safety, Tolerability, Pharmacokinetics, and Effect on Disease Progression of BIIB067 Administered to Previously Treated Adults with Amyotrophic Lateral Sclerosis Caused by Superoxide Dismutase 1 Mutation | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 20.0;Level: PT;Classification code 10077024;Term: Familial amyotrophic lateral sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 21.1;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: BIIB067 (ISIS666853) INN or Proposed INN: Tofersen Other descriptive name: BIIB067 | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 183 | Phase 3 | United States;Spain;Israel;Italy;United Kingdom;European Union;Canada;Belgium;Poland;Australia;Denmark;Germany;Japan;New Zealand | ||
| 266 | EUCTR2017-002754-36-NL (EUCTR) | 30/08/2018 | 22/05/2018 | Effects of oral Levosimendan on breathing function in patients with the disease Amyotrophic Lateral Sclerosis (ALS) | Effects of oral Levosimendan (ODM-109) on respiratory function in patients with ALS - REFALS | Amyotrophic lateral sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Oral LEVOSIMENDAN Product Code: ODM-109 INN or Proposed INN: LEVOSIMENDAN | Orion Corporation | NULL | Not Recruiting | Female: yes Male: yes | 496 | Phase 3 | United States;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Canada;Belgium;Australia;Netherlands;Germany;Sweden | ||
| 267 | NCT03613571 (ClinicalTrials.gov) | August 15, 2018 | 15/6/2018 | A Study to Evaluate the Safety, Tolerability and Efficacy of ILB in Patients With Amyotrophic Lateral Sclerosis | A Single-centre, Open Single-arm Study Where the Safety, Tolerability and Efficacy of Subcutaneously Administered ILB Will be Evaluated in Patients With Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis | Drug: ILB | TikoMed AB | NULL | Terminated | 18 Years | 80 Years | All | 13 | Phase 2 | Sweden |
| 268 | EUCTR2018-000586-37-NL (EUCTR) | 15/08/2018 | 04/06/2018 | A Study to Evaluate the Efficacy, Safety and Tolerability of CK-2127107 In Patients with Amyotrophic Lateral Sclerosis (ALS) | A Phase 2, Multi-Center, Double-Blind, Randomized, Dose-Ranging, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability Of CK-2127107 In Patients with Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 20.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Reldesemtiv Product Code: CK-2127107 INN or Proposed INN: Reldesemtiv Other descriptive name: Reldesemtiv | Cytokinetics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 445 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Canada;Spain;Ireland;Australia;Netherlands | ||
| 269 | EUCTR2018-000668-28-GB (EUCTR) | 09/08/2018 | 25/06/2018 | A study to assess safety and acceptability of a treatment in patients with ALS | A Phase II pilot safety and tolerability study of ILB in patients with Motor Neurone Disease (MND)/Amyotrophic Lateral Sclerosis (ALS) - The ALS Study | Motor Neurone Disease (MND)/Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 20.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ILB: 100mg/ml solution for injection and infusion INN or Proposed INN: Dextran Sodium Sulfur Salt 5, Mw 5 kDa. a type of Low Molecular Weight Dextran Sulfate (LMW-DS) Other descriptive name: ILB | University of Birmingham | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 15 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United Kingdom | ||
| 270 | NCT03652805 (ClinicalTrials.gov) | August 1, 2018 | 13/8/2018 | A Study of IPL344 in the Treatment of ALS Patients | Phase 1/2a, Multi-center, Open-Label, Dose-escalating Study to Assess Safety, Tolerability, and Pharmacokinetics of Intravenously Administered IPL344 for The Treatment of Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis | Drug: IPL344 | Immunity Pharma Ltd. | NULL | Recruiting | 18 Years | 80 Years | All | 15 | Phase 1/Phase 2 | Israel |
| 271 | NCT03491462 (ClinicalTrials.gov) | July 31, 2018 | 27/3/2018 | Arimoclomol in Amyotropic Lateral Sclerosis | A Phase 3, Randomised, Placebo-Controlled Trial of Arimoclomol in Amyotropic Lateral Sclerosis | Amyotrophic Lateral Sclerosis | Drug: Arimoclomol;Drug: Placebo oral capsule | Orphazyme | NULL | Completed | 18 Years | N/A | All | 245 | Phase 3 | United States;Belgium;Canada;France;Germany;Italy;Netherlands;Poland;Spain;Sweden;Switzerland;United Kingdom;Denmark |
| 272 | EUCTR2018-000586-37-ES (EUCTR) | 19/07/2018 | 23/05/2018 | A Study to Evaluate the Efficacy, Safety and Tolerability of CK-2127107 In Patients with Amyotrophic Lateral Sclerosis (ALS) | A Phase 2, Multi-Center, Double-Blind, Randomized, Dose-Ranging, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability Of CK-2127107 In Patients with Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 20.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Reldesemtiv Product Code: CK-2127107 INN or Proposed INN: Reldesemtiv Other descriptive name: Reldesemtiv | Cytokinetics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 445 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Canada;Spain;Ireland;Australia;Netherlands | ||
| 273 | EUCTR2017-002754-36-IT (EUCTR) | 05/07/2018 | 01/10/2021 | Effects of oral Levosimendan on breathing function in patients with the disease Amyotrophic Lateral Sclerosis (ALS) | Effects of oral Levosimendan (ODM-109) on respiratory function in patients with ALS - REFALS | Amyotrophic lateral sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Oral LEVOSIMENDAN Product Code: [ODM-109] INN or Proposed INN: LEVOSIMENDAN | ORION CORPORATION ORION PHARMA | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | United States;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Canada;Belgium;Australia;Germany;Netherlands;Sweden | ||
| 274 | JPRN-jRCT2071210022 | 03/07/2018 | 12/05/2021 | Clinical Pharmacology Study of EPI-589 | Clinical Pharmacology Study of EPI-589 (DA301006) | Amyotrophic lateral sclerosis | Part A : Single oral administration (EPI-589 250, 500, 1000 mg/day or placebo) Part B : Single oral administration (EPI-589 500 mg/day or placebo) Part C : Multiple oral administration (EPI-589 1000, 1500 mg/day or placebo) Part D : Single oral administration (EPI-589 500 mg/day) | Hamatani Tatsuto | NULL | Complete | >= 20age old | <= 55age old | Male | 68 | Phase 1 | Japan |
| 275 | NCT03506425 (ClinicalTrials.gov) | June 21, 2018 | 13/4/2018 | A Pilot Trial of Triheptanoin for People With Amyotrophic Lateral Sclerosis (PALS) | A Pilot Trial of Triheptanoin for People With Amyotrophic Lateral Sclerosis (PALS) | ALS | Drug: Triheptanoin | Richard Bedlack, M.D., Ph.D. | Ultragenyx Pharmaceutical Inc | Completed | 18 Years | N/A | All | 15 | Phase 1/Phase 2 | United States |
| 276 | NCT03505021 (ClinicalTrials.gov) | June 21, 2018 | 16/4/2018 | Effects of Oral Levosimendan (ODM-109) on Respiratory Function in Patients With ALS | Effects of Oral Levosimendan (ODM-109) on Respiratory Function in Patients With ALS | Amyotrophic Lateral Sclerosis | Drug: Levosimendan;Drug: Placebo for levosimendan | Orion Corporation, Orion Pharma | NULL | Completed | 18 Years | 120 Years | All | 496 | Phase 3 | United States;Australia;Austria;Belgium;Canada;Finland;France;Germany;Ireland;Italy;Netherlands;Spain;Sweden;United Kingdom |
| 277 | NCT03472950 (ClinicalTrials.gov) | June 11, 2018 | 1/3/2018 | Safety and Efficacy of Ranolazine for the Treatment of Amyotrophic Lateral Sclerosis | Safety and Efficacy of Ranolazine for the Treatment of Amyotrophic Lateral Sclerosis | ALS | Drug: Ranolazine 500 MG;Drug: Ranolazine 1000 MG | University of Kansas Medical Center | Gilead Sciences | Recruiting | 18 Years | N/A | All | 20 | Phase 2 | United States |
| 278 | NCT03537807 (ClinicalTrials.gov) | June 2018 | 9/5/2018 | Expanded Access Protocol of BHV-0223 for Patients With Amyotrophic Lateral Sclerosis (ALS) | BHV-0223 Expanded Access Protocol in Patients With Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis;ALS;Lou Gehrig Disease;Lou Gehrig's Disease;Lou-Gehrigs Disease;Motor Neuron Disease, Amyotrophic Lateral Sclerosis | Drug: Riluzole | Biohaven Pharmaceuticals, Inc. | NULL | No longer available | 18 Years | N/A | All | NULL | ||
| 279 | EUCTR2017-003763-35-FR (EUCTR) | 17/05/2018 | 05/03/2018 | conservative iron chelation by deferiprone for amyotrophic lateral sclerosis | Conservative Iron Chelation by Deferiprone as a disease-modifying Strategy for Amyotrophic Lateral Sclerosis using a Multicentre Parallel group, placebo controlled, Randomized clinical trial - FAIR ALS II | De novo Amyotrophic Lateral Sclerosis patients;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Deferiprone DR INN or Proposed INN: DEFERIPRONE | centre hospitalier universitaire de Lille | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 3 | France | ||
| 280 | EUCTR2017-002754-36-BE (EUCTR) | 15/05/2018 | 28/02/2018 | Effects of oral Levosimendan on breathing function in patients with the disease Amyotrophic Lateral Sclerosis (ALS) | Effects of oral Levosimendan (ODM-109) on respiratory function in patients with ALS - REFALS | Amyotrophic lateral sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Oral LEVOSIMENDAN Product Code: ODM-109 INN or Proposed INN: LEVOSIMENDAN | Orion Corporation | NULL | Not Recruiting | Female: yes Male: yes | 496 | Phase 3 | United States;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Canada;Belgium;Australia;Netherlands;Germany;Sweden | ||
| 281 | EUCTR2017-005065-47-SE (EUCTR) | 15/05/2018 | 19/03/2018 | A single-center, open single-arm study where the safety, tolerability and efficacy of subcutaneously administered ILB will be evaluated in patients with Amyotrophic Lateral Sclerosis. | A single-centre, open single-arm study where the safety, tolerability and efficacy of subcutaneously administered ILB will be evaluated in patients with Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis (ALS);Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: ILB Product Code: ILB INN or Proposed INN: ILB Other descriptive name: DEXTRAN SULFATE SODIUM | TikoMed AB | NULL | Not Recruiting | Female: yes Male: yes | 15 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Sweden | ||
| 282 | EUCTR2018-000142-18-FI (EUCTR) | 09/05/2018 | 08/05/2018 | Feasibility and effects of subcutaneously given combination of dexmedetomidine and ketamine in ALS patients receiving palliative care | Feasibility and pharmacodynamics of subcutaneously given combination of dexmedetomidine and ketamine infusion in ALS patients receiving palliative care | Amyotrophic lateral sclerosis (ALS) MedDRA version: 20.1;Level: LLT;Classification code 10036704;Term: Primary lateral sclerosis;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Dexdor INN or Proposed INN: DEXMEDETOMIDINE Trade Name: Ketanest-S INN or Proposed INN: ESKETAMINE | Turku University Hospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Phase 4 | Finland | ||
| 283 | EUCTR2017-002754-36-IE (EUCTR) | 08/05/2018 | 25/01/2018 | Effects of oral Levosimendan on breathing function in patients with the disease Amyotrophic Lateral Sclerosis (ALS) | Effects of oral Levosimendan (ODM-109) on respiratory function in patients with ALS - REFALS | Amyotrophic lateral sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Oral LEVOSIMENDAN Product Code: ODM-109 INN or Proposed INN: LEVOSIMENDAN | Orion Corporation | NULL | Not Recruiting | Female: yes Male: yes | 496 | Phase 3 | United States;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Canada;Belgium;Australia;Germany;Netherlands;Sweden | ||
| 284 | EUCTR2017-002754-36-GB (EUCTR) | 04/05/2018 | 30/01/2018 | Effects of oral Levosimendan on breathing function in patients with the disease Amyotrophic Lateral Sclerosis (ALS) | Effects of oral Levosimendan (ODM-109) on respiratory function in patients with ALS - REFALS | Amyotrophic lateral sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Oral LEVOSIMENDAN Product Code: ODM-109 INN or Proposed INN: LEVOSIMENDAN | Orion Corporation | NULL | Not Recruiting | Female: yes Male: yes | 496 | Phase 3 | Germany;Netherlands;Sweden;United States;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Canada;Belgium;Australia | ||
| 285 | EUCTR2017-002754-36-ES (EUCTR) | 29/04/2018 | 14/03/2018 | Effects of oral Levosimendan on breathing function in patients with the disease Amyotrophic Lateral Sclerosis (ALS) | Effects of oral Levosimendan (ODM-109) on respiratory function in patients with ALS - REFALS | Amyotrophic lateral sclerosis (ALS) MedDRA version: 20.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Oral LEVOSIMENDAN Product Code: ODM-109 INN or Proposed INN: LEVOSIMENDAN | Orion Corporation | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | United States;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Canada;Belgium;Australia;Germany;Netherlands;Sweden | ||
| 286 | EUCTR2017-002754-36-FI (EUCTR) | 19/04/2018 | 28/02/2018 | Effects of oral Levosimendan on breathing function in patients with the disease Amyotrophic Lateral Sclerosis (ALS) | Effects of oral Levosimendan (ODM-109) on respiratory function in patients with ALS - REFALS | Amyotrophic lateral sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Oral LEVOSIMENDAN Product Code: ODM-109 INN or Proposed INN: LEVOSIMENDAN | Orion Corporation | NULL | Not Recruiting | Female: yes Male: yes | 496 | Phase 3 | United States;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Canada;Belgium;Australia;Netherlands;Germany;Sweden | ||
| 287 | EUCTR2017-002754-36-AT (EUCTR) | 17/04/2018 | 08/03/2018 | Effects of oral Levosimendan on breathing function in patients with the disease Amyotrophic Lateral Sclerosis (ALS) | Effects of oral Levosimendan (ODM-109) on respiratory function in patients with ALS - REFALS | Amyotrophic lateral sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Oral LEVOSIMENDAN Product Code: ODM-109 INN or Proposed INN: LEVOSIMENDAN | Orion Corporation | NULL | Not Recruiting | Female: yes Male: yes | 496 | Phase 3 | United States;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Canada;Belgium;Australia;Germany;Netherlands;Sweden | ||
| 288 | NCT03482050 (ClinicalTrials.gov) | April 12, 2018 | 14/3/2018 | A Study to Evaluate Transplantation of Astrocytes Derived From Human Embryonic Stem Cells, in Patients With Amyotrophic Lateral Sclerosis (ALS) | A Phase I/IIa, Open Label, Dose-escalating Clinical Study to Evaluate the Safety, Tolerability and Theraputic Effects of Transplantation of Astrocytes Derived From Human Embryonic Stem Cells (hESC), in Patients With Amyotrophic Lateral Sclerosis (ALS) | ALS (Amyotrophic Lateral Sclerosis) | Biological: AstroRx | Kadimastem | NULL | Completed | 18 Years | 70 Years | All | 16 | Phase 1/Phase 2 | Israel |
| 289 | NCT03334786 (ClinicalTrials.gov) | April 5, 2018 | 26/10/2017 | Study to Evaluate Safety & Efficacy of FLX-787-ODT to Treat Fasciculations in Tongue and Appendicular Muscle in Adult Subjects With ALS | An Open Label Study to Evaluate the Safety and Efficacy of FLX-787-ODT for Treatment of Fasciculations in the Tongue and One Appendicular Muscle in Adult Subjects With Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis;Fasciculation | Drug: FLX-787-ODT | Flex Pharma, Inc. | NULL | Terminated | 18 Years | N/A | All | 3 | Phase 1/Phase 2 | United States |
| 290 | NCT03679975 (ClinicalTrials.gov) | April 4, 2018 | 19/9/2018 | Riluzole Oral Soluble Film (ROSF) Swallowing Safety in Amyotrophic Lateral Sclerosis (ALS) | A Single Center Study to Evaluate the Effect of Riluzole Oral Soluble Film on Swallowing Safety in Individuals With Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis | Drug: Riluzole Oral Soluble film (ROSF) 50 mg | Aquestive Therapeutics | inVentiv Health Clinical;Covance | Terminated | 18 Years | 80 Years | All | 9 | Phase 2 | United States |
| 291 | NCT03488524 (ClinicalTrials.gov) | March 29, 2018 | 23/3/2018 | Open Label Extension Study of AMX0035 in Patients With ALS | Open Label Extension Study of AMX0035 in Patients With ALS | Amyotrophic Lateral Sclerosis;ALS | Drug: AMX0035 | Amylyx Pharmaceuticals Inc. | Massachusetts General Hospital Neurology Clinical Research Institute | Completed | N/A | N/A | All | 95 | Phase 2 | United States |
| 292 | NCT03457753 (ClinicalTrials.gov) | March 1, 2018 | 26/2/2018 | Riluzole Oral Soluble Film Safety and Tolerability in Amyotrophic Lateral Sclerosis | A Multi-Center, Open Label Study to Assess the Safety and Tolerability of Riluzole Oral Soluble Film in Subjects With Amyotrophic Lateral Sclerosis Over 12 Weeks of Twice Daily Treatment. | ALS | Drug: Riluzole Oral Soluble Film | Aquestive Therapeutics | Inventiv Health;Covance | Withdrawn | 18 Years | 80 Years | All | 0 | Phase 2 | United States |
| 293 | NCT03520517 (ClinicalTrials.gov) | February 2, 2018 | 17/4/2018 | Open-label Study to Evaluate Safety, Tolerability and PK of BHV-0223 in ALS | Open-Label Study to Evaluate Safety, Tolerability and Pharmacokinetics of Multiple Doses of BHV-0223 in Subjects With Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis;ALS;Lou Gehrig Disease;Lou Gehrig's Disease;Lou-Gehrigs Disease;Motor Neuron Disease, Amyotrophic Lateral Sclerosis | Drug: BHV-0223 | Biohaven Pharmaceuticals, Inc. | Cognitive Research Corporation | Completed | 18 Years | N/A | All | 22 | Phase 1 | United States |
| 294 | NCT03427086 (ClinicalTrials.gov) | January 29, 2018 | 29/1/2018 | Safety and Tolerability of High Dose Biotin in Patients With Amyotrophic Lateral Sclerosis | Safety and Tolerability of High Dose Biotin in Patients With Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis | Drug: Biotin;Drug: Placebo Oral Tablet | American University of Beirut Medical Center | NULL | Completed | 18 Years | 80 Years | All | 12 | Phase 2 | Lebanon |
| 295 | NCT03136809 (ClinicalTrials.gov) | January 18, 2018 | 28/4/2017 | ALS Treatment Extension Study | A Treatment Continuation Study for Patients With Amyotrophic Lateral Sclerosis/Motor Neuron Disease Who Have Successfully Completed Study CMD-2016-001 | Amyotrophic Lateral Sclerosis | Drug: Cu(II)ATSM | Collaborative Medicinal Development Pty Limited | NULL | Active, not recruiting | 18 Years | 75 Years | All | 28 | Phase 1/Phase 2 | Australia |
| 296 | NCT03548311 (ClinicalTrials.gov) | November 1, 2017 | 14/5/2018 | Clinical Trial of Ultra-high Dose Methylcobalamin for ALS | Japanese Early-stage Clinical Trial of Ultra-high Dose Methylcobalamin for Amyotrophic Lateral Sclerosis: a Pivotal Phase 3 Randomized Controlled Study | Amyotrophic Lateral Sclerosis | Drug: methylcobalamin;Drug: saline solution | University of Tokushima | Eisai Co., Ltd. | Unknown status | 20 Years | N/A | All | 128 | Phase 3 | Japan |
| 297 | NCT03338114 (ClinicalTrials.gov) | November 2017 | 6/11/2017 | Study to Evaluate the Safety & Efficacy of FLX-787-ODT to Treat Fasciculations in Tongue and Upper or Lower Extremity Muscles Most Affected in Subjects With ALS | An Open Label Study to Evaluate the Safety and Efficacy of FLX-787-ODT for Treatment of Fasciculations in the Tongue and Upper or Lower Extremity Muscles Most Affected in Subjects With Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis;Fasciculation | Drug: FLX-787-ODT (orally disintigrating tablet) | Flex Pharma, Inc. | NULL | Withdrawn | 18 Years | N/A | All | 0 | Phase 1/Phase 2 | United States |
| 298 | NCT03272503 (ClinicalTrials.gov) | October 27, 2017 | 31/8/2017 | A Clinical Trial of Pimozide in Patients With Amyotrophic Lateral Sclerosis (ALS) | A Phase II Randomized, Placebo-Controlled, Double Blinded, Multi-Centre Clinical Trial of Pimozide in Patients With Amyotrophic Lateral Sclerosis | ALS;Amyotrophic Lateral Sclerosis | Drug: Pimozide 2mg/day (current) or 4 mg/day (study initiation);Drug: Placebo Oral Tablet | University of Calgary | ALS Canada;Brain Canada | Recruiting | 18 Years | N/A | All | 100 | Phase 2 | Canada |
| 299 | NCT03268603 (ClinicalTrials.gov) | October 10, 2017 | 30/8/2017 | Intrathecal Autologous Adipose-derived Mesenchymal Stromal Cells for Amyotrophic Lateral Sclerosis (ALS) | A Phase II Study of Intrathecal Autologous Adipose-derived Mesenchymal Stromal Cells for Amyotrophic Lateral Sclerosis | ALS;Amyotrophic Lateral Sclerosis | Drug: Autologous Adipose-derived Mesenchymal Stromal Cells | Mayo Clinic | State of Minnesota Regenerative Medicine Minnesota | Active, not recruiting | 18 Years | N/A | All | 75 | Phase 2 | United States |
| 300 | NCT03487263 (ClinicalTrials.gov) | October 1, 2017 | 9/3/2018 | Dose-Escalation, Safety and Pharmacokinetic Study of IC14 in Motor Neurone Disease | A Phase 1b, Open-Label, Dose-Escalation, Safety and Pharmacokinetic Study of IC14 in Motor Neurone Disease | Motor Neuron Disease;Amyotrophic Lateral Sclerosis | Biological: IC14 | Implicit Bioscience | Royal Brisbane and Women's Hospital | Completed | 18 Years | 75 Years | All | 10 | Phase 1 | Australia |
| 301 | NCT03168711 (ClinicalTrials.gov) | October 1, 2017 | 24/5/2017 | Safety of Urate Elevation in Amyotrophic Lateral Sclerosis (ALS) | Safety of Urate Elevation in Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis | Drug: Inosine;Drug: Placebo | Massachusetts General Hospital | The Salah Foundation;MGH cure ALS Fund | Completed | 18 Years | 85 Years | All | 23 | Phase 2 | United States |
| 302 | EUCTR2016-003225-41-GB (EUCTR) | 20/09/2017 | 02/06/2017 | Long-Term Evaluation of BIIB067 | An Extension Study to Assess the Long-Term Safety, Tolerability, Pharmacokinetics, and Effect on Disease Progression of BIIB067 Administered to Previously Treated Adults with Amyotrophic Lateral Sclerosis Caused by Superoxide Dismutase 1 Mutation - Biogen 233AS102 Study of BIIB067 in Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 20.0;Level: PT;Classification code 10077024;Term: Familial amyotrophic lateral sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 21.1;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: BIIB067 (ISIS666853) INN or Proposed INN: - Other descriptive name: BIIB067 | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 183 | Phase 1;Phase 3 | United States;Japan;United Kingdom;Spain;Canada;Sweden;Belgium;Denmark;Poland;Italy;Australia;France;Germany | ||
| 303 | EUCTR2016-002629-13-BE (EUCTR) | 04/09/2017 | 21/04/2017 | An Open-Label Extension Study for Patients Who Completed VITALITY-ALS (CY 4031) | A Phase 3, Open-Label Extension Study of Tirasemtiv for Patients with Amyotrophic Lateral Sclerosis (ALS) who Completed VITALITY-ALS (CY 4031) - VIGOR-ALS | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 19.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Tirasemtiv Product Code: CK-2017357 INN or Proposed INN: Tirasemtiv Other descriptive name: 6-ethynyl-1-(pentan-3-yl)-1H-imidazo[4,5-b]pyrazin-2(3H)-one | Cytokinetics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | Portugal;France;United States;Canada;Spain;Belgium;Ireland;Netherlands;Germany;Italy;United Kingdom | ||
| 304 | EUCTR2016-002629-13-PT (EUCTR) | 28/08/2017 | 04/05/2017 | An Open-Label Extension Study for Patients Who Completed VITALITY-ALS (CY 4031) | A Phase 3, Open-Label Extension Study of Tirasemtiv for Patients with Amyotrophic Lateral Sclerosis (ALS) who Completed VITALITY-ALS (CY 4031) - VIGOR-ALS | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 20.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Tirasemtiv Product Code: CK-2017357 INN or Proposed INN: Tirasemtiv Other descriptive name: 6-ethynyl-1-(pentan-3-yl)-1H-imidazo[4,5-b]pyrazin-2(3H)-one | Cytokinetics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 350 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;United States;Portugal;Canada;Belgium;Spain;Ireland;Netherlands;Germany;Italy;United Kingdom | ||
| 305 | NCT03280056 (ClinicalTrials.gov) | August 28, 2017 | 29/8/2017 | Safety and Efficacy of Repeated Administrations of NurOwn® in ALS Patients | A Phase 3, Randomized Double-Blind, Placebo-Controlled Multicenter Study to Evaluate Efficacy and Safety of Repeated Administration of NurOwn® (Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors) in Participants With ALS | Amyotrophic Lateral Sclerosis (ALS) | Biological: NurOwn® (MSC-NTF cells);Other: Placebo;Other: Bone Marrow aspiration | Brainstorm-Cell Therapeutics | California Institute for Regenerative Medicine (CIRM) | Completed | 18 Years | 60 Years | All | 263 | Phase 3 | United States |
| 306 | NCT03707795 (ClinicalTrials.gov) | August 21, 2017 | 14/9/2017 | Treatment of FUS-Related ALS With Betamethasone - The TRANSLATE Study | Treatment of FUS-Related ALS With Betamethasone - The TRANSLATE Study | Familial Amyotrophic Lateral Sclerosis | Drug: Betamethasone sodium phosphate/betamethasone acetate (Celestone® Soluspan®), 30 mg IM once a day for four days | Edward Kasaraskis | NULL | Completed | 20 Years | 80 Years | All | 6 | Early Phase 1 | United States |
| 307 | NCT03237741 (ClinicalTrials.gov) | August 7, 2017 | 31/7/2017 | Bioavailability of GDC-0134 and the Effect of Food and Proton Pump Inhibitor on Pharmacokinetics of GDC-0134 in Healthy Female Participants | A Phase I Open-Label Study to Determine the Relative Bioavailability of GDC-0134 and to Investigate the Effect of Food and Proton Pump Inhibitor on Pharmacokinetics of GDC-0134 in Healthy Female Subjects of Non-childbearing Potential | Amyotrophic Lateral Sclerosis | Drug: Reference capsule GDC-0134;Drug: Prototype capsule GDC-0134;Drug: rabeprazole | Genentech, Inc. | Quotient Clinical | Completed | 30 Years | 65 Years | Female | 24 | Phase 1 | United Kingdom |
| 308 | NCT03160898 (ClinicalTrials.gov) | July 24, 2017 | 12/5/2017 | A Study to Evaluate Efficacy, Safety and Tolerability of CK-2127107 in Patients With Amyotrophic Lateral Sclerosis (ALS) | A Phase 2, Multi-Center, Double-Blind, Randomized, Dose-Ranging, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of CK-2127107 in Patients With Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis | Drug: Reldesemtiv;Drug: Placebo | Cytokinetics | Astellas Pharma Inc | Completed | 18 Years | 80 Years | All | 458 | Phase 2 | United States;Australia;Canada;Ireland;Netherlands;Spain |
| 309 | JPRN-UMIN000029308 | 2017/07/18 | 30/09/2018 | Study on efficacy and safety as well as on the changes in blood purine compounds by the treatment of patients with amyotrophic lateral sclerosis with febuxostat and inosine in combination. | Study on efficacy and safety as well as on the changes in blood purine compounds by the treatment of patients with amyotrophic lateral sclerosis with febuxostat and inosine in combination. - Effect of febuxostat and inosine on amyotrophic lateral sclerosis | Amyotrophic lateral sclerosis | Febuxostat 20 mg, Inosine 500 mg, twice a day for 14 days | Teikyo University | NULL | Complete: follow-up complete | 20years-old | 80years-old | Male and Female | 3 | Not applicable | Japan |
| 310 | EUCTR2016-002399-28-IT (EUCTR) | 14/07/2017 | 23/01/2018 | Rapamycin (Sirolimus) treatment for amyotrophic lateral sclerosis | Rapamycin (Sirolimus) treatment for amyotrophic lateral sclerosis - RAP.ALS | definite or probable ALS MedDRA version: 20.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: RAPAMUNE - 1 MG 100 COMPRESSE RIVESTITE IN BLISTER USO ORALE Product Name: Rapamune | AZIENDA OSPEDALIERO-UNIVERSITARIA POLICLINICO DI MODENA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 63 | Phase 2 | Italy | ||
| 311 | NCT03186040 (ClinicalTrials.gov) | July 13, 2017 | 5/6/2017 | Open-label Clinical Trial of Lacosamide in ALS | Open-label Clinical Trial: Safety of Lacosamide in Patients With Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis | Drug: Lacosamide | Chiba University | NULL | Completed | 20 Years | N/A | All | 7 | Phase 1/Phase 2 | Japan |
| 312 | JPRN-jRCTs031180173 | 07/07/2017 | 01/03/2019 | Open-label clinical trial: safety of lacosamide in patients with amyotrophic lateral sclerosis | Open-label clinical trial: safety of lacosamide in patients with amyotrophic lateral sclerosis | amyotrophic lateral sclerosis amyotrophic lateral sclerosis;G122 | gradual increase of lacosamide from 100mg to 400mg for 4 weeks | Kuwabara Satoshi | NULL | Complete | >= 20age old | Not applicable | Both | 30 | Phase 1-2 | Japan |
| 313 | NCT03068754 (ClinicalTrials.gov) | June 22, 2017 | 23/2/2017 | Study of Acthar® Gel (Acthar) for Amyotrophic Lateral Sclerosis (ALS) | A Multicenter, Double Blind, Placebo Controlled Study to Assess the Efficacy and Safety of H.P. Acthar® Gel in the Treatment of Subjects With Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis | Drug: Acthar;Drug: Placebo | Mallinckrodt | NULL | Terminated | 18 Years | 75 Years | All | 143 | Phase 2/Phase 3 | United States;Argentina;Canada;Chile;Colombia;Mexico;Peru |
| 314 | NCT03127514 (ClinicalTrials.gov) | June 22, 2017 | 12/4/2017 | AMX0035 in Patients With Amyotrophic Lateral Sclerosis (ALS) | Evaluation of the Safety, Tolerability, Efficacy and Activity of AMX0035, a Fixed Combination of Phenylbutyrate (PB) and Tauroursodeoxycholic Acid (TUDCA), for the Treatment of ALS | Amyotrophic Lateral Sclerosis;Motor Neuron Disease;Neuromuscular Diseases;Neurodegenerative Diseases;Spinal Cord Diseases;TDP-43 Proteinopathies;Nervous System Diseases;Central Nervous System Diseases | Drug: AMX0035;Other: Placebo | Amylyx Pharmaceuticals Inc. | ALS Finding a Cure Foundation;ALS Association;Northeast ALS Consortium;Massachusetts General Hospital Neurology Clinical Research Institute;Leandro P. Rizzuto Foundation | Completed | 18 Years | 80 Years | All | 137 | Phase 2/Phase 3 | United States |
| 315 | NCT03039673 (ClinicalTrials.gov) | June 19, 2017 | 31/1/2017 | MIROCALS: Modifying Immune Response and OutComes in ALS | Efficacy and Safety of Low-dose IL-2 (Ld-IL-2) as a Treg Enhancer for Controlling Neuro-inflammation in Newly Diagnosed Amyotrophic Lateral Sclerosis (ALS) Patients: A Randomized, Double-blind, Placebo- Controlled, Phase-II Proof of Concept/ Proof of Mechanism Clinical Trial | Amyotrophic Lateral Sclerosis | Drug: Riluzole;Drug: IL-2;Drug: 5% glucose water solution | Centre Hospitalier Universitaire de Nimes | NULL | Completed | 18 Years | 75 Years | All | 304 | Phase 2 | France;United Kingdom |
| 316 | EUCTR2016-002629-13-NL (EUCTR) | 07/06/2017 | 14/03/2017 | An Open-Label Extension Study for Patients Who Completed VITALITY-ALS (CY 4031) | A Phase 3, Open-Label Extension Study of Tirasemtiv for Patients with Amyotrophic Lateral Sclerosis (ALS) who Completed VITALITY-ALS (CY 4031) - VIGOR-ALS | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 19.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Tirasemtiv Product Code: CK-2017357 INN or Proposed INN: Tirasemtiv Other descriptive name: 6-ethynyl-1-(pentan-3-yl)-1H-imidazo[4,5-b]pyrazin-2(3H)-one | Cytokinetics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | Portugal;France;United States;Canada;Belgium;Spain;Ireland;Germany;Netherlands;Italy;United Kingdom | ||
| 317 | EUCTR2016-002629-13-GB (EUCTR) | 05/06/2017 | 09/02/2018 | An Open-Label Extension Study for Patients Who Completed VITALITY-ALS (CY 4031) | A Phase 3, Open-Label Extension Study of Tirasemtiv for Patients with Amyotrophic Lateral Sclerosis (ALS) who Completed VITALITY-ALS (CY 4031) - VIGOR-ALS | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 20.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Tirasemtiv Product Code: CK-2017357 INN or Proposed INN: Tirasemtiv Other descriptive name: 6-ethynyl-1-(pentan-3-yl)-1H-imidazo[4,5-b]pyrazin-2(3H)-one | Cytokinetics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 350 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;France;United States;Canada;Belgium;Spain;Ireland;Netherlands;Germany;Italy;United Kingdom | ||
| 318 | NCT03324399 (ClinicalTrials.gov) | June 1, 2017 | 5/9/2017 | A Study of Protein Metabolism, Microbiome and Investigational Probiotic Use in Patients With ALS | A Study of Protein Metabolism, Microbiome and Investigational Probiotic Use in Patients With Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis;ALS | Dietary Supplement: probiotic | Avera McKennan Hospital & University Health Center | NULL | Completed | 18 Years | N/A | All | 5 | N/A | United States |
| 319 | JPRN-UMIN000027476 | 2017/06/01 | 01/06/2017 | Open-label clinical trial: safety of lacosamide in patients with amyotrophic lateral sclerosis | Open-label clinical trial: safety of lacosamide in patients with amyotrophic lateral sclerosis - Open-label clinical trial of lacosamide in ALS | amyotrophic lateral sclerosis | gradual increase of lacosamide from 100mg to 400mg for 4 weeks | Department of Neurology Chiba University Hospital | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 30 | Not selected | Japan |
| 320 | EUCTR2016-002629-13-FR (EUCTR) | 22/05/2017 | 16/05/2017 | An Open-Label Extension Study for Patients Who Completed VITALITY-ALS (CY 4031) | A Phase 3, Open-Label Extension Study of Tirasemtiv for Patients with Amyotrophic Lateral Sclerosis (ALS) who Completed VITALITY-ALS (CY 4031) - VIGOR-ALS | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 20.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Tirasemtiv Product Code: CK-2017357 INN or Proposed INN: Tirasemtiv Other descriptive name: 6-ethynyl-1-(pentan-3-yl)-1H-imidazo[4,5-b]pyrazin-2(3H)-one | Cytokinetics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 350 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;United States;France;Canada;Belgium;Spain;Ireland;Netherlands;Germany;Italy;United Kingdom | ||
| 321 | NCT03019419 (ClinicalTrials.gov) | April 24, 2017 | 10/1/2017 | Perampanel for Sporadic Amyotrophic Lateral Sclerosis (ALS) | Perampanel for Sporadic Amyotrophic Lateral Sclerosis (ALS): A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase 2 Trials | ALS | Drug: Perampanel;Drug: placebo | Tokyo Medical University | NULL | Completed | 40 Years | 78 Years | All | 66 | Phase 2 | Japan |
| 322 | JPRN-UMIN000025614 | 2017/04/24 | 01/02/2017 | Perampanel for sporadic amyotrophic lateral sclerosis (ALS): A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase 2 Trial | Perampanel for sporadic amyotrophic lateral sclerosis (ALS): A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase 2 Trial - Perampanel for sporadic amyotrophic lateral sclerosis (ALS) | Sporadic amyotrophic lateral sclerosis | Once daily perampanel with dose-escalation tolerable from 2mg to 4mg for 48 weeks (Interventions) Once daily perampanel with dose-escalation tolerable from 2mg to 8mg for 48 weeks (Interventions). Once daily placebo for 48 weeks (Control) | Department of Neurology, Tokyo Medical University | NULL | Complete: follow-up complete | 40years-old | 78years-old | Male and Female | 60 | Phase 2 | Japan |
| 323 | NCT03103815 (ClinicalTrials.gov) | April 24, 2017 | 1/4/2017 | Trial of Amivita in Amyotrophic Lateral Sclerosis | Trial of Amivita in Amyotrophic Lateral Sclerosis: a Single-center, Single-blind, Self-controlled Clinical Trial | Amyotrophic Lateral Sclerosis | Drug: Amivita | Wujin People's Hospital | Nanjing 1718 Biotech Co. Ltd | Recruiting | 18 Years | 70 Years | All | 30 | N/A | China |
| 324 | EUCTR2016-002629-13-ES (EUCTR) | 12/04/2017 | 10/03/2017 | An Open-Label Extension Study for Patients Who Completed VITALITY-ALS (CY 4031) | A Phase 3, Open-Label Extension Study of Tirasemtiv for Patients with Amyotrophic Lateral Sclerosis (ALS) who Completed VITALITY-ALS (CY 4031) - VIGOR-ALS | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 19.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Tirasemtiv Product Code: CK-2017357 INN or Proposed INN: Tirasemtiv Other descriptive name: 6-ethynyl-1-(pentan-3-yl)-1H-imidazo[4,5-b]pyrazin-2(3H)-one | Cytokinetics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | Portugal;France;United States;Canada;Belgium;Spain;Ireland;Netherlands;Germany;Italy;United Kingdom | ||
| 325 | EUCTR2016-003225-41-BE (EUCTR) | 10/04/2017 | 10/04/2017 | Long-Term Evaluation of BIIB067 | An Extension Study to Assess the Long-Term Safety, Tolerability, Pharmacokinetics, and Effect on Disease Progression of BIIB067 Administered to Previously Treated Adults with Amyotrophic Lateral Sclerosis Caused by Superoxide Dismutase 1 Mutation | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 20.0;Level: PT;Classification code 10077024;Term: Familial amyotrophic lateral sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 21.1;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: BIIB067 (ISIS666853) INN or Proposed INN: Tofersen Other descriptive name: BIIB067 | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 183 | Phase 3 | United States;Spain;Israel;Italy;United Kingdom;European Union;Canada;Belgium;Poland;Australia;Denmark;Germany;Japan;Korea, Republic of | ||
| 326 | NCT03049046 (ClinicalTrials.gov) | April 7, 2017 | 3/2/2017 | CC100: Phase 1 Multiple-Dose Safety and Tolerability in Subjects With ALS | Protocol CC100B. CC100: Phase 1 Multiple-Dose Safety and Tolerability in Subjects With ALS | Amyotrophic Lateral Sclerosis | Drug: CC100;Drug: Placebos | Chemigen, LLC | NULL | Recruiting | 18 Years | 64 Years | All | 21 | Phase 1 | United States |
| 327 | NCT02943850 (ClinicalTrials.gov) | April 1, 2017 | 20/10/2016 | CNS10-NPC-GDNF for the Treatment of ALS | Human Neural Progenitor Cells Secreting Glial Cell Line-Derived Neurotrophic Factor (CNS10-NPC-GDNF) for the Treatment of Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis | Biological: Stem cell (HPC) implantation;Device: Stereotactic surgical device | Cedars-Sinai Medical Center | California Institute for Regenerative Medicine (CIRM) | Completed | 18 Years | N/A | All | 18 | Phase 1 | United States |
| 328 | EUCTR2016-002629-13-IT (EUCTR) | 28/03/2017 | 20/01/2021 | An Open-Label Extension Study for Patients Who Completed VITALITY-ALS (CY 4031) | A Phase 3, Open-Label Extension Study of Tirasemtiv for Patients with Amyotrophic Lateral Sclerosis (ALS) who Completed VITALITY-ALS (CY 4031) - VIGOR-ALS | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Tirasemtiv Product Code: CK-2017357 INN or Proposed INN: Tirasemtiv Other descriptive name: 6-ethynyl-1-(pentan-3-yl)-1H-imidazo[4,5-b]pyrazin-2(3H)-one | CYTOKINETICS, INC. | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | Portugal;France;United States;Canada;Spain;Belgium;Ireland;Netherlands;Germany;United Kingdom;Italy | ||
| 329 | NCT03272802 (ClinicalTrials.gov) | March 16, 2017 | 2/9/2017 | Treatment Effect of Edaravone in Patients With Amyotrophic Lateral Sclerosis (ALS) | Treatment Effect of Edaravone in Patients With Amyotrophic Lateral Sclerosis (ALS) in a Representative Iranian Population | Neuromuscular Diseases | Drug: Edaravone;Drug: Riluzole | Isfahan University of Medical Sciences | NULL | Active, not recruiting | 18 Years | 75 Years | All | 20 | Phase 2/Phase 3 | Iran, Islamic Republic of |
| 330 | NCT03070119 (ClinicalTrials.gov) | March 8, 2017 | 28/2/2017 | Long-Term Evaluation of BIIB067 | An Extension Study to Assess the Long-Term Safety, Tolerability, Pharmacokinetics, and Effect on Disease Progression of BIIB067 Administered to Previously Treated Adults With Amyotrophic Lateral Sclerosis Caused by Superoxide Dismutase 1 Mutation | ALS Caused by Superoxide Dismutase 1 (SOD1) Mutation | Drug: BIIB067 | Biogen | Ionis Pharmaceuticals, Inc. | Active, not recruiting | 18 Years | N/A | All | 138 | Phase 3 | United States;Belgium;Canada;France;Germany;Italy;Japan;New Zealand;United Kingdom |
| 331 | JPRN-UMIN000026221 | 2017/03/02 | 01/03/2017 | Safety of perampanel in patients with motor neuron disease | Safety of perampanel in patients with motor neuron disease - Safety of perampanel in patients with motor neuron disease | amyotrophic lateral sclerosis | Once daily perampanel with dose escalation from 2mg to 8mg. | Department of Neurology, Juntendo University School of Medicine | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 15 | Phase 1 | Japan |
| 332 | EUCTR2016-002629-13-IE (EUCTR) | 28/02/2017 | 25/11/2016 | An Open-Label Extension Study for Patients Who Completed VITALITY-ALS (CY 4031) | A Phase 3, Open-Label Extension Study of Tirasemtiv for Patients with Amyotrophic Lateral Sclerosis (ALS) who Completed VITALITY-ALS (CY 4031) - VIGOR-ALS | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 20.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Tirasemtiv Product Code: CK-2017357 INN or Proposed INN: Tirasemtiv Other descriptive name: 6-ethynyl-1-(pentan-3-yl)-1H-imidazo[4,5-b]pyrazin-2(3H)-one | Cytokinetics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | Portugal;France;United States;Canada;Belgium;Spain;Ireland;Netherlands;Germany;Italy;United Kingdom | ||
| 333 | NCT03214146 (ClinicalTrials.gov) | February 1, 2017 | 9/7/2017 | Safety/Efficacy Study of 2nd Cycle Treatment After 6 Months of 1st Cycle HLA-haplo Matched Allogenic Bone Marrow Derived Stem Cell Treatment in ALS | An Open-label, Phase 1 Trial for Safety and Efficacy Study of 2nd Cycle Treatment After 6 Months of 1st Cycle HLA-haplo Matched Allogenic Bone Marrow Derived Stem Cell(HYNR-CS-Allo Inj) Treatment in Amyotrophic Lateral Sclerosis(ALS) | Amyotrophic Lateral Sclerosis | Biological: HYNRCS-Allo inj | Hanyang University Seoul Hospital | Corestem, Inc. | Active, not recruiting | 25 Years | 80 Years | All | 6 | Phase 1 | Korea, Republic of |
| 334 | EUCTR2016-002382-62-IT (EUCTR) | 13/01/2017 | 22/06/2021 | The effects of RNS60 on ALS biomarkers | The effects of RNS60 on ALS biomarkers - RNS60-ALS | Amyotrophic Lateral Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Level: LLT;Classification code 10052889;Term: ALS;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: RNS60 Product Code: RNS60 Product Name: RNS60 Product Code: RNS60 | IRCCS- ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRI | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 142 | Phase 2 | United States;Italy | ||
| 335 | NCT03020797 (ClinicalTrials.gov) | January 12, 2017 | 15/12/2016 | A Clinical Trial to Evaluate the Safety and Efficacy of Fycompa in Subjects With Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis | Drug: Perampanel;Drug: Placebo Oral Tablet | Stony Brook University | Eisai Inc. | Recruiting | 18 Years | 80 Years | All | 60 | N/A | United States | |
| 336 | NCT03073239 (ClinicalTrials.gov) | December 2016 | 26/3/2016 | Amyotrophic Lateral Sclerosis: a New Paradigm | Amyotrophic Lateral Sclerosis: a New Paradigm | Amyotrophic Lateral Sclerosis | Genetic: ALS patients genetic characterization;Other: ALS patients epidemiological caracterization | Conde, Bebiana, M.D. | NULL | Completed | 18 Years | N/A | All | 30 | Portugal | |
| 337 | EUCTR2014-005413-23-IE (EUCTR) | 30/11/2016 | 10/09/2015 | Ventilatory Investigation of Tirasemtiv and Assessment of Longitudinal Indices After Treatment for a Year (VITALITY-ALS) | A Phase 3, Multi-National, Double-Blind, Randomized, Placebo-Controlled, Stratified, Parallel Group, Study to Evaluate the Safety, Tolerability and Efficacy of Tirasemtiv in Patients with Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 20.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Tirasemtiv Product Code: CK-2017357 INN or Proposed INN: Tirasemtiv Other descriptive name: 6-ethynyl-1-(pentan-3-yl)-1H-imidazo[4,5-b]pyrazin-2(3H)-one | Cytokinetics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Portugal;France;United States;Canada;Belgium;Spain;Ireland;Netherlands;Germany;Italy;United Kingdom | ||
| 338 | NCT03456882 (ClinicalTrials.gov) | November 18, 2016 | 2/2/2018 | The Effect of RNS60 on ALS Biomarkers | The Effect of RNS60 on ALS Biomarkers | Amyotrophic Lateral Sclerosis | Drug: RNS60 | Mario Negri Institute for Pharmacological Research | ALS Association;Get out ONLUS | Completed | 18 Years | 80 Years | All | 142 | Phase 2 | United States;Italy |
| 339 | NCT02870634 (ClinicalTrials.gov) | November 16, 2016 | 10/8/2016 | Phase 1 Dose Escalation and PK Study of Cu(II)ATSM in ALS/MND | A Phase 1 Single and Multiple Dose Escalation and Pharmacokinetic Study of Cu(II)ATSM Administered Orally to Patients With Amyotrophic Lateral Sclerosis/Motor Neuron Disease | Amyotrophic Lateral Sclerosis;Motor Neuron Disease | Drug: Cu(II)ATSM | Collaborative Medicinal Development Pty Limited | NULL | Completed | 18 Years | 75 Years | All | 50 | Phase 1 | Australia |
| 340 | JPRN-UMIN000024854 | 2016/11/16 | 16/11/2016 | Clinical study of the effectiveness of edaravone for the oxidative stress in amyotrophic lateral sclerosis | Clinical study of the effectiveness of edaravone for the oxidative stress in amyotrophic lateral sclerosis - Clinical study for the anti-oxidative stress by edaravone in ALS | Amyotrophic Lateral Sclerosis (ALS) | Edaravone treatment for ALS patients | Okayama university | NULL | Complete: follow-up complete | 20years-old | 75years-old | Male and Female | 20 | Not applicable | Japan |
| 341 | NCT02936635 (ClinicalTrials.gov) | October 17, 2016 | 12/10/2016 | A Study for Patients Who Completed VITALITY-ALS (CY 4031) | A Phase 3, Open-Label Extension Study of Tirasemtiv for Patients With Amyotrophic Lateral Sclerosis (ALS) Who Completed VITALITY-ALS (CY 4031) | Amyotrophic Lateral Sclerosis (ALS) | Drug: tirasemtiv | Cytokinetics | NULL | Completed | 18 Years | N/A | All | 280 | Phase 3 | United States;Belgium;Canada;France;Germany;Ireland;Italy;Netherlands;Portugal;Spain;United Kingdom |
| 342 | NCT02868580 (ClinicalTrials.gov) | October 2016 | 16/6/2016 | Safety and Tolerability of Antiretroviral (Triumeq) in Patients With Amyotrophic Lateral Sclerosis (ALS). | Phase 2a Open Label Study, Safety and Tolerability of Combination Antiretroviral Therapy (Triumeq) in Participants With Amyotrophic Lateral Sclerosis (ALS) - The Lighthouse Project. | Amyotrophic Lateral Sclerosis | Drug: Triumeq | Neuroscience Trials Australia | Macquarie University, Australia;Westmead Hosptial;Calvary Health Care Bethlehem;The University of Sydney - Brain and Mind Centre | Completed | 18 Years | 75 Years | All | 43 | Phase 2 | Australia |
| 343 | NCT02781454 (ClinicalTrials.gov) | October 2016 | 10/5/2016 | Mexiletine in Sporadic Amyotrophic Lateral Sclerosis | Effect of Mexiletine on Cortical Hyperexcitability in Sporadic Amyotrophic Lateral Sclerosis (SALS) | Sporadic Amyotrophic Lateral Sclerosis | Drug: Mexiletine;Drug: Placebo | University of Washington | Massachusetts General Hospital | Completed | 18 Years | N/A | All | 20 | Phase 2 | United States |
| 344 | JPRN-UMIN000024312 | 2016/09/20 | 25/05/2017 | Studies of efficacy and safety of the combined use of febuxostat and inosine for patients with Alzheimer's disease, Parkinson's disease, amyotrophic lateral sclerosis or multiple sclerosis, and changes of blood and urine purine compounds. | Studies of efficacy and safety of the combined use of febuxostat and inosine for patients with Alzheimer's disease, Parkinson's disease, amyotrophic lateral sclerosis or multiple sclerosis, and changes of blood and urine purine compounds. - Effect of febuxostat and inosine on CNS diseases | Alzheimer's disease, Parkinson's disease, amyotrophic lateral sclerosis or multiple sclerosis | Treatment with febuxostat 20 mg and inosine 0.5 g, twice a day for 2 weeks | Tsukuba International Clinical Pharmacology Clinic | NULL | Complete: follow-up complete | 20years-old | 80years-old | Male and Female | 12 | Not selected | Japan |
| 345 | NCT03067857 (ClinicalTrials.gov) | September 2016 | 25/2/2017 | Autologous Bone Marrow-Derived Stem Cell Therapy for Motor Neuron Disease | Autologous Purified Bone-Marrow-Derived Stem Cell Therapy for Motor Neuron Disease | Motor Neuron Disease;Amyotrophic Lateral Sclerosis;Primary Lateral Sclerosis;Progressive Muscular Atrophy;Progressive Bulbar Palsies | Biological: Stem Cells | Stem Cells Arabia | NULL | Unknown status | 24 Years | 70 Years | All | 40 | Phase 1/Phase 2 | NULL |
| 346 | NCT02794857 (ClinicalTrials.gov) | August 29, 2016 | 24/5/2016 | Safety and Efficacy Study of NP001 in Patients With Amyotrophic Lateral Sclerosis (ALS) and Systemic Inflammation | A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of NP001 in Subjects With Amyotrophic Lateral Sclerosis (ALS) and Evidence of Elevated Systemic Inflammation | Amyotrophic Lateral Sclerosis | Drug: NP001;Drug: Placebo | Neuraltus Pharmaceuticals, Inc. | NULL | Completed | 21 Years | 80 Years | All | 138 | Phase 2 | United States;Canada |
| 347 | NCT02872142 (ClinicalTrials.gov) | August 29, 2016 | 11/8/2016 | Efficacy and Safety of Plasma Exchange With Albutein® 5% in Patients With Amyotrophic Lateral Sclerosis | Pilot Study to Evaluate the Efficacy and Safety of Plasma Exchange With Albutein® 5% in Patients With Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis | Biological: Albutein 5% | Grifols Therapeutics LLC | Grifols Biologicals, LLC | Completed | 19 Years | 69 Years | All | 12 | Phase 2 | United States |
| 348 | EUCTR2015-005347-14-GB (EUCTR) | 25/08/2016 | 09/05/2016 | Efficacy and safety of low-dose IL-2 (ld-IL-2) as a Treg enhancer for controlling neuro-inflammation in newly diagnosed Amyotrophic Lateral Sclerosis (ALS) patients | Efficacy and safety of low-dose IL-2 (ld-IL-2) as a Treg enhancer for controlling neuro-inflammation in newly diagnosed Amyotrophic Lateral Sclerosis (ALS) patients:A randomized, double-blind, placebo- controlled, phase-II Proof of Concept/ Proof of Mechanism Clinical Trial - MIROCALS | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 20.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Proleukin 18 MUI Product Name: proleukin | CHU DE NIMES | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 216 | Phase 2 | United Kingdom | ||
| 349 | EUCTR2015-004098-33-DE (EUCTR) | 16/08/2016 | 07/12/2015 | An Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of BIIB067 in Adults With Inherited Amyotrophic Lateral Sclerosis (ALS) | A Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BIIB067 Administered to Adult Subjects with Amyotrophic Lateral Sclerosis and Confirmed Superoxide Dismutase 1 Mutation | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 20.0;Level: PT;Classification code 10077024;Term: Familial amyotrophic lateral sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 21.1;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: BIIB067 (ISIS666853) Other descriptive name: BIIB067 | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 183 | Phase 1;Phase 2;Phase 3 | United States;Japan;United Kingdom;Canada;Sweden;Belgium;Denmark;Korea, Republic of;Poland;Italy;Australia;France;Germany | ||
| 350 | NCT03114215 (ClinicalTrials.gov) | June 29, 2016 | 28/3/2017 | Effect of MD1003 in Amyotrophic Lateral Sclerosis | Effect of MD1003 in Amyotrophic Lateral Sclerosis: a Randomized Double Blind Placebo Controlled Pilot Study | ALS;Amyotrophic Lateral Sclerosis;Motor Neuron Disease | Drug: MD1003;Drug: Placebo oral capsule | MedDay Pharmaceuticals SA | NULL | Completed | 25 Years | 80 Years | All | 30 | Phase 2 | France |
| 351 | EUCTR2015-004098-33-SE (EUCTR) | 29/06/2016 | 27/11/2015 | An Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of BIIB067 in Adults With Inherited Amyotrophic Lateral Sclerosis (ALS) | A Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BIIB067 Administered to Adult Subjects with Amyotrophic Lateral Sclerosis and Confirmed Superoxide Dismutase 1 Mutation | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 20.0;Level: PT;Classification code 10077024;Term: Familial amyotrophic lateral sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 20.0;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: BIIB067 (ISIS666853) Other descriptive name: BIIB067 | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 144 | Phase 1;Phase 2;Phase 3 | Belgium;United States;France;Canada;Denmark;Australia;Germany;United Kingdom;Japan;Italy;Sweden | ||
| 352 | NCT03876002 (ClinicalTrials.gov) | June 28, 2016 | 13/3/2019 | Evaluation of Microglial Activation in ALS With [18F]PBR06 (Peripheral Benzodiazepine Receptor-06) PET | Evaluation of Microglial Activation Using the PET Imaging Ligand [18F]PBR06 in Patients With Amyotrophic Lateral Sclerosis Compared to Healthy Volunteers | Healthy Volunteers;Amyotrophic Lateral Sclerosis | Drug: [18F]PBR06 | Molecular NeuroImaging | NULL | Completed | 18 Years | 80 Years | All | 23 | Phase 1 | United States |
| 353 | NCT03835507 (ClinicalTrials.gov) | June 20, 2016 | 8/8/2018 | Randomized, Double-blind, Safety and Efficacy of Recombinant Human Erythropoietin in Amyotrophic Lateral Sclerosis | Randomized, Double-blind, Safety and Efficacy of Recombinant Human Erythropoietin in Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis | Drug: recombinant human erythropoietin(rhEPO) | Hanyang University Seoul Hospital | NULL | Recruiting | 25 Years | 80 Years | All | 64 | Phase 1/Phase 2 | Korea, Republic of |
| 354 | EUCTR2015-005810-31-FR (EUCTR) | 03/06/2016 | 24/10/2016 | Effect of MD1003 in amyotrophic lateral sclerosis: a randomized, double blind placebo controlled study | Effect of MD1003 in amyotrophic lateral sclerosis: a randomized, double blind placebo controlled study - MD1003-ALS | Amyotrophic lateral sclerosis MedDRA version: 19.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: MD1003 INN or Proposed INN: BIOTIN | MEDDAY PHARMACEUTICALS | NULL | Not Recruiting | Female: yes Male: yes | 30 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France | ||
| 355 | NCT02655614 (ClinicalTrials.gov) | May 31, 2016 | 7/1/2016 | A Study of GDC-0134 to Determine Initial Safety, Tolerability, and Pharmacokinetic Parameters in Participants With Amyotrophic Lateral Sclerosis | A Phase I, Double-Blind, Randomized, Placebo-Controlled, Multicenter, Single- and Multiple-Ascending-Dose Study to Determine Initial Safety, Tolerability, and Pharmacokinetics of GDC-0134 in Patients With Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis | Drug: GDC-0134;Drug: Placebo;Drug: Rabeprazole;Drug: Midazolam;Drug: Caffeine | Genentech, Inc. | NULL | Completed | 18 Years | N/A | All | 54 | Phase 1 | United States;Canada;Netherlands |
| 356 | EUCTR2014-005413-23-IT (EUCTR) | 30/05/2016 | 16/02/2018 | Ventilatory Investigation of Tirasemtiv and Assessment of Longitudinal Indices After Treatment for a Year (VITALITY-ALS) | A Phase 3, Multi-National, Double-Blind, Randomized, Placebo-Controlled, Stratified, Parallel Group, Study to Evaluate the Safety, Tolerability and Efficacy of Tirasemtiv in Patients with Amyotrophic Lateral Sclerosis (ALS) - - | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 20.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Tirasemtiv Product Code: CK-2017357 INN or Proposed INN: Tirasemtiv Other descriptive name: 6-ethynyl-1-(pentan-3-yl)-1H-imidazo[4,5-b]pyrazin-2(3H)-one | CYTOKINETICS, INC. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Portugal;France;United States;Canada;Belgium;Spain;Ireland;Netherlands;Germany;United Kingdom;Italy | ||
| 357 | EUCTR2014-005413-23-DE (EUCTR) | 20/05/2016 | 21/08/2015 | Ventilatory Investigation of Tirasemtiv and Assessment of Longitudinal Indices After Treatment for a Year (VITALITY-ALS) | A Phase 3, Multi-National, Double-Blind, Randomized, Placebo-Controlled, Stratified, Parallel Group, Study to Evaluate the Safety, Tolerability and Efficacy of Tirasemtiv in Patients with Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 20.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Tirasemtiv Product Code: CK-2017357 INN or Proposed INN: Tirasemtiv Other descriptive name: 6-ethynyl-1-(pentan-3-yl)-1H-imidazo[4,5-b]pyrazin-2(3H)-one | Cytokinetics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;France;United States;Canada;Belgium;Spain;Ireland;Netherlands;Germany;Italy;United Kingdom | ||
| 358 | NCT03241784 (ClinicalTrials.gov) | May 16, 2016 | 27/7/2017 | T-Regulatory Cells in Amyotrophic Lateral Sclerosis | Expansion and Infusion of T-Regulatory Cells in Amyotrophic Lateral Sclerosis | ALS (Amyotrophic Lateral Sclerosis) | Biological: Autologous T-regulatory lymphocytes;Biological: Interleukin-2 | Stanley H. Appel, MD | NULL | Unknown status | 18 Years | N/A | All | 4 | Phase 1 | United States |
| 359 | EUCTR2014-005413-23-PT (EUCTR) | 09/05/2016 | 03/02/2016 | Ventilatory Investigation of Tirasemtiv and Assessment of Longitudinal Indices After Treatment for a Year (VITALITY-ALS) | A Phase 3, Multi-National, Double-Blind, Randomized, Placebo-Controlled, Stratified, Parallel Group, Study to Evaluate the Safety, Tolerability and Efficacy of Tirasemtiv in Patients with Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 18.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Tirasemtiv Product Code: CK-2017357 INN or Proposed INN: Tirasemtiv Other descriptive name: 6-ethynyl-1-(pentan-3-yl)-1H-imidazo[4,5-b]pyrazin-2(3H)-one | Cytokinetics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;United States;Portugal;Canada;Belgium;Spain;Ireland;Netherlands;Germany;Italy;United Kingdom | ||
| 360 | NCT02714036 (ClinicalTrials.gov) | May 6, 2016 | 9/3/2016 | A Biomarker Study to Evaluate MN-166 (Ibudilast) in Subjects With Amyotrophic Literal Sclerosis (ALS) | A Multi-Center, Open-Label Biomarker Study to Evaluate MN-166 (Ibudilast) in Subjects With Amyotrophic Literal Sclerosis (ALS) | Amyotrophic Lateral Sclerosis | Drug: ibudilast | MediciNova | Massachusetts General Hospital;South Shore Neurologic Associates | Completed | 18 Years | N/A | All | 35 | Phase 1/Phase 2 | United States |
| 361 | NCT04454840 (ClinicalTrials.gov) | May 1, 2016 | 29/6/2020 | Treatment of Intravenous Infusion Plasma in Amyotrophic Lateral Sclerosis | A Clinical Study on Safety and Effectiveness of Intravenous Infusion Plasma From Healthy Young People to Treat Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis | Biological: Plasma from healthy young people treatment + Riluzole;Drug: Riluzole | Peking University Third Hospital | NULL | Completed | N/A | N/A | All | 20 | Early Phase 1 | China |
| 362 | NCT03204500 (ClinicalTrials.gov) | May 2016 | 28/6/2017 | Dual Treatment With Lithium and Valproate in ALS. | A Randomized Clinical Trial, Double Blind, Placebo-controlled of Lithium and Valproate in Amyotrophic Lateral Sclerosis. | Amyotrophic Lateral Sclerosis;Amyotrophic Lateral Sclerosis, Sporadic | Combination Product: Active treatment with dual therapy;Drug: Placebos | El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez | NULL | Completed | 40 Years | 70 Years | All | 43 | Phase 2 | Mexico |
| 363 | EUCTR2014-005413-23-BE (EUCTR) | 20/04/2016 | 26/02/2016 | Ventilatory Investigation of Tirasemtiv and Assessment of Longitudinal Indices After Treatment for a Year (VITALITY-ALS) | A Phase 3, Multi-National, Double-Blind, Randomized, Placebo-Controlled, Stratified, Parallel Group, Study to Evaluate the Safety, Tolerability and Efficacy of Tirasemtiv in Patients with Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 20.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Tirasemtiv Product Code: CK-2017357 INN or Proposed INN: Tirasemtiv Other descriptive name: 6-ethynyl-1-(pentan-3-yl)-1H-imidazo[4,5-b]pyrazin-2(3H)-one | Cytokinetics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Portugal;France;United States;Canada;Spain;Belgium;Ireland;Netherlands;Germany;Italy;United Kingdom | ||
| 364 | EUCTR2015-004098-33-GB (EUCTR) | 18/04/2016 | 10/12/2015 | An Efficacy, Safety, Tolerability, Pharmacokinetics and PharmacodynamicsStudy of BIIB067 in Adults With Inherited Amyotrophic Lateral Sclerosis (ALS) | A Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics andPharmacodynamics of BIIB067 Administered to Adult Subjects with Amyotrophic Lateral Sclerosis and Confirmed Superoxide Dismutase 1 Mutation - Biogen 233AS101 | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 20.0;Level: PT;Classification code 10077024;Term: Familial amyotrophic lateral sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 21.1;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: BIIB067 (ISIS666853) Other descriptive name: BIIB067 | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 183 | Phase 1;Phase 2;Phase 3 | France;United States;Canada;Belgium;Denmark;Australia;Germany;Japan;Italy;United Kingdom;Korea, Republic of;Sweden | ||
| 365 | EUCTR2014-005413-23-NL (EUCTR) | 06/04/2016 | 30/11/2015 | Ventilatory Investigation of Tirasemtiv and Assessment of Longitudinal Indices After Treatment for a Year (VITALITY-ALS) | A Phase 3, Multi-National, Double-Blind, Randomized, Placebo-Controlled, Stratified, Parallel Group, Study to Evaluate the Safety, Tolerability and Efficacy of Tirasemtiv in Patients with Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 20.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Tirasemtiv Product Code: CK-2017357 INN or Proposed INN: Tirasemtiv Other descriptive name: 6-ethynyl-1-(pentan-3-yl)-1H-imidazo[4,5-b]pyrazin-2(3H)-one | Cytokinetics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Portugal;France;United States;Canada;Belgium;Spain;Ireland;Germany;Netherlands;Italy;United Kingdom | ||
| 366 | NCT02709330 (ClinicalTrials.gov) | April 2016 | 5/3/2016 | ALS Reversals - Lunasin Regimen | An Open-label, Single-center, 12-month Trial of a Lunasin Regimen for Patients With Amyotrophic Lateral Sclerosis (ALS) | ALS (Amyotrophic Lateral Sclerosis) | Drug: Lunasin Regimen;Other: Historical control | Richard Bedlack, M.D., Ph.D. | NULL | Completed | 18 Years | N/A | All | 60 | Phase 2 | United States |
| 367 | EUCTR2015-004098-33-BE (EUCTR) | 01/03/2016 | 14/01/2016 | An Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of BIIB067 in Adults With Inherited Amyotrophic Lateral Sclerosis (ALS) | A Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BIIB067 Administered to Adult Subjects with Amyotrophic Lateral Sclerosis and Confirmed Superoxide Dismutase 1 Mutation | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 20.0;Level: PT;Classification code 10077024;Term: Familial amyotrophic lateral sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 20.0;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: BIIB067 (ISIS666853) Other descriptive name: BIIB067 | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 144 | Phase 1;Phase 2;Phase 3 | United States;France;Canada;Poland;Belgium;Denmark;Australia;Germany;United Kingdom;Japan;Italy;Sweden | ||
| 368 | EUCTR2014-005367-32-IT (EUCTR) | 29/02/2016 | 17/03/2017 | Clinical study on the efficacy and tolerabilty of Guabenz in Amiotropic Lateral Sclerosis | PROTEIN MISFOLDING, AMYOTROPHIC LATERAL SCLEROSIS AND GUANABENZ: A PHASE II RCT WITH FUTILITY DESIGN - PROMISE | Amiotrophic Lateral Sclerosis MedDRA version: 19.1;Level: PT;Classification code 10028003;Term: Motor neurone disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: GUANABENZ ACETATO Product Code: GUANA2015 INN or Proposed INN: GUANABENZ Other descriptive name: GUANABENZ Product Name: RILUZOLO INN or Proposed INN: RILUZOLO Other descriptive name: RILUZOLO | FONDAZIONE IRCCS ISTITUTO NEUROLOGICO CARLO BESTA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 208 | Phase 2 | Italy | ||
| 369 | EUCTR2014-005413-23-ES (EUCTR) | 09/02/2016 | 10/12/2015 | Ventilatory Investigation of Tirasemtiv and Assessment of Longitudinal Indices After Treatment for a Year (VITALITY-ALS) | A Phase 3, Multi-National, Double-Blind, Randomized, Placebo-Controlled, Stratified, Parallel Group, Study to Evaluate the Safety, Tolerability and Efficacy of Tirasemtiv in Patients with Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 18.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Tirasemtiv Product Code: CK-2017357 INN or Proposed INN: Tirasemtiv Other descriptive name: 6-ethynyl-1-(pentan-3-yl)-1H-imidazo[4,5-b]pyrazin-2(3H)-one | Cytokinetics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 445 | Phase 3 | Portugal;France;United States;Canada;Belgium;Spain;Ireland;Netherlands;Germany;United Kingdom | ||
| 370 | NCT02460679 (ClinicalTrials.gov) | January 14, 2016 | 21/5/2015 | Safety and Biomarker Study of EPI-589 in Participants With Amyotrophic Lateral Sclerosis (ALS) | A Phase 2A Safety and Biomarker Study of EPI-589 in Subjects With Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis | Drug: EPI-589 | PTC Therapeutics | NULL | Completed | 21 Years | 70 Years | All | 19 | Phase 2 | United States |
| 371 | NCT04821479 (ClinicalTrials.gov) | January 1, 2016 | 19/10/2020 | Repeated Mesenchymal Stem Cell Injections in ALS | Safety and Clinical Effects of Repeated Intrathecal Injections of Autologous Mesenchymal Stem Cells in Patients With Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis | Biological: Mesenchymal stem cells (MSC) | Hadassah Medical Organization | NULL | Completed | 18 Years | 65 Years | All | 20 | Phase 1/Phase 2 | NULL |
| 372 | EUCTR2014-005413-23-GB (EUCTR) | 01/12/2015 | 27/08/2015 | Ventilatory Investigation of Tirasemtiv and Assessment of Longitudinal Indices After Treatment for a Year (VITALITY-ALS) | A Phase 3, Multi-National, Double-Blind, Randomized, Placebo-Controlled, Stratified, Parallel Group, Study to Evaluate the Safety, Tolerability and Efficacy of Tirasemtiv in Patients with Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 20.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Tirasemtiv Product Code: CK-2017357 INN or Proposed INN: Tirasemtiv Other descriptive name: 6-ethynyl-1-(pentan-3-yl)-1H-imidazo[4,5-b]pyrazin-2(3H)-one | Cytokinetics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;France;United States;Canada;Belgium;Spain;Ireland;Netherlands;Germany;Italy;United Kingdom | ||
| 373 | ChiCTR-IPR-15007365 | 2015-11-04 | 2015-11-03 | A Multi-center, Randomized, Double Blinding, Placebo-Controlled Clinical Trial of Dl-3-Butylphthalide in the Treatment of Amyotrophic Lateral Sclerosis | A Multi-center, Randomized, Double Blinding, Placebo-Controlled Clinical Trial of Dl-3-Butylphthalide in the Treatment of Amyotrophic Lateral Sclerosis | amyotrophic lateral sclerosis | Treatment group:to give Butylphthalide soft capsules, 2 / time, 3 times / day, fasting;Control group:to give placebo, 2 / time, 3 times / day, fasting; | Peking Union Medical College Hospital | NULL | Recruiting | Both | Treatment group:147;Control group:147; | China | |||
| 374 | EUCTR2014-004567-21-NL (EUCTR) | 04/11/2015 | 04/08/2015 | Effects of ODM-109 on respiratory function in patients with ALS. | Effects of ODM-109 on respiratory function in patients with ALS. A randomised, double blind, placebo-controlled, cross-over, 3-period, multicentre study with open-label follow-up extension - LEVALS | Amyotrophic lateral sclerosis (ALS). A rapidly progressive neurological disease characterized by degeneration of upper and lower motor neurons with subsequent muscle atrophy and weakness and loss of respiratory function. The latter is due to the weakness and loss of the diaphragm muscle strength. MedDRA version: 18.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ODM-109 capsule 1 mg INN or Proposed INN: LEVOSIMENDAN | Orion Corporation Orion Pharma | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 2 | Ireland;Germany;Netherlands;United Kingdom | ||
| 375 | NCT02559869 (ClinicalTrials.gov) | November 2015 | 23/9/2015 | Imaging and BioFluid Biomarkers in Amyotrophic Lateral Sclerosis | Imaging and BioFluid Biomarkers in Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis (ALS) | Drug: [18F] GE-180 | Massachusetts General Hospital | The Methodist Hospital System;Cedars-Sinai Medical Center;ALS Association | Completed | 18 Years | 80 Years | All | 86 | United States | |
| 376 | NCT02469896 (ClinicalTrials.gov) | November 2015 | 3/6/2015 | A Trial of Tocilizumab in ALS Subjects | A Phase 2 Randomized, Placebo Controlled Trial of Tocilizumab in ALS Subjects | ALS;Amyotrophic Lateral Sclerosis;Lou Gehrig's Disease;Motor Neuron Disease | Drug: Tocilizumab;Other: Placebo | Barrow Neurological Institute | ALS Association;Barrow Neurological Foundation;Massachusetts General Hospital;Genentech, Inc. | Completed | 18 Years | 75 Years | All | 22 | Phase 2 | United States |
| 377 | NCT03296501 (ClinicalTrials.gov) | October 13, 2015 | 21/9/2017 | Intraspinal Transplantation of Autologous ADRC in ALS Patients | Safety and Efficacy of Intraspinal Transplantation of Autologous ADRC in ALS Patients | Amyotrophic Lateral Sclerosis | Biological: Cell-based therapy of autologous adipose derived regenerative cells transplanted intraspinally and intrathecally in ALS patients | Mossakowski Medical Research Centre Polish Academy of Sciences | Medical University of Warsaw | Active, not recruiting | 18 Years | 65 Years | All | 30 | Phase 1 | Poland |
| 378 | JPRN-UMIN000019111 | 2015/10/01 | 01/10/2015 | CaHMB L-arginine-glutamine blended drinks (Abound (TM)) for amyotrophic lateral sclerosis patients and sarcopenia improvement effect by drinking. | CaHMB L-arginine-glutamine blended drinks (Abound (TM)) for amyotrophic lateral sclerosis patients and sarcopenia improvement effect by drinking. - The sarcopenia improvement effect by Abound (TM) drinking against ALS | Amyotrophic lateral sclerosis | Abound(TM) 1,Take one pack twice a day in the moring and evening 2,Drinking was dissolved in water 240 ~ 300ml 3,Before meals, after meals does not matter 4,12 weeks | National Hospital Organization Takasaki General Medical Center | NULL | Recruiting | Not applicable | Not applicable | Male and Female | 20 | Not selected | Japan |
| 379 | NCT02525471 (ClinicalTrials.gov) | October 2015 | 12/8/2015 | A Pilot Study of RNS60 in Amyotrophic Lateral Sclerosis (ALS) | ALS | Drug: RNS60 | Sabrina Paganoni, M.D. | NULL | Completed | 18 Years | 80 Years | All | 24 | Phase 1 | United States | |
| 380 | EUCTR2014-004567-21-DE (EUCTR) | 22/09/2015 | 09/03/2015 | Effects of ODM-109 on respiratory function in patients with ALS. | Effects of ODM-109 on respiratory function in patients with ALS. A randomised, double blind, placebo-controlled, cross-over, 3-period, multicentre study with open-label follow-up extension - LEVALS | Amyotrophic lateral sclerosis (ALS). A rapidly progressive neurological disease characterized by degeneration of upper and lower motor neurons with subsequent muscle atrophy and weakness and loss of respiratory function. The latter is due to the weakness and loss of the diaphragm muscle strength. MedDRA version: 19.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ODM-109 capsule 1 mg INN or Proposed INN: LEVOSIMENDAN | Orion Corporation Orion Pharma | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 2 | Ireland;Netherlands;Germany;United Kingdom | ||
| 381 | EUCTR2010-024423-24-NL (EUCTR) | 21/09/2015 | 09/09/2015 | Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS) | A prospective, multicenter, randomized, double-blind, placebocontrolled, parallel groups, phase 2/3 study to compare the efficacy and safety of masitinib versus placebo in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - not applicable | patients suffering from Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 19.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: na INN or Proposed INN: Masitinib mesylate Other descriptive name: na Product Name: masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: na INN or Proposed INN: Masitinib mesylate Other descriptive name: na | ABScience | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2;Phase 3 | Portugal;United States;Serbia;Slovakia;Greece;Spain;Ireland;Colombia;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Argentina;Romania;Netherlands;Germany | ||
| 382 | NCT02496767 (ClinicalTrials.gov) | September 3, 2015 | 10/7/2015 | Ventilatory Investigation of Tirasemtiv and Assessment of Longitudinal Indices After Treatment for a Year | A Phase 3, Multi-National, Double-Blind, Randomized, Placebo-Controlled, Stratified, Parallel Group, Study to Evaluate the Safety, Tolerability and Efficacy of Tirasemtiv in Patients With Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis | Drug: Tirasemtiv;Drug: Placebo tablets | Cytokinetics | NULL | Completed | 18 Years | N/A | All | 744 | Phase 3 | United States;Belgium;Canada;France;Germany;Ireland;Italy;Netherlands;Portugal;Spain;United Kingdom |
| 383 | NCT02059759 (ClinicalTrials.gov) | September 2015 | 7/2/2014 | Immuno-modulation in Amyotrophic Lateral Sclerosis- a Phase II Study of Safety and Activity of Low Dose Interleukin-2 | Immuno-modulation in Amyotrophic Lateral Sclerosis- a Phase II Study of Safety and Activity of Low Dose Interleukin-2 | Amyotrophic Lateral Sclerosis | Drug: Placebo;Drug: 1.0 MIU IL-2 per day;Drug: 2.0 MIU IL-2 per day | Centre Hospitalier Universitaire de Nimes | NULL | Completed | 18 Years | 75 Years | Both | 36 | Phase 2 | France |
| 384 | EUCTR2015-001431-20-NL (EUCTR) | 17/08/2015 | 21/04/2015 | Trial to look at the nerve conductance in patients with ALS, with and without Riluzole or Retigabine. | A randomized, double blind, double-dummy placebo controlled, 3-way cross-over study to determine the test-retest reliability of, and the effect of oral retigabine and riluzole on, peripheral motor nerve excitability measurements in patients with ALS. - Peripheral motor nerve excitability study in patients with ALS | Amytrophic Lateral Sclerosis MedDRA version: 18.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Rilutek 50 mg film-coated tablets Product Name: Rilutek INN or Proposed INN: RILUZOLE Trade Name: Trobalt Product Name: Trobalt INN or Proposed INN: RETIGABINE | Centre for Human Drug Research | NULL | Not Recruiting | Female: yes Male: yes | Phase 2 | Netherlands | |||
| 385 | NCT02851914 (ClinicalTrials.gov) | July 21, 2015 | 28/7/2016 | SSRIs vs. TCAs for Depression in ALS Patients | An Open-Label Pilot Study Comparing the Efficacy of Selective Serotonin Re-Uptake Inhibitors (SSRIs) Versus Tricyclic Antidepressants (TCAs) for Treating Depression in Amyotrophic Lateral Sclerosis | Depression;Amyotrophic Lateral Sclerosis | Drug: Tricyclic Antidepressants (TCA);Drug: Selective Serotonin Uptake Inhibitors (SSRI) | St. Louis University | NULL | Completed | 25 Years | 80 Years | All | 2 | Early Phase 1 | United States |
| 386 | NCT02487407 (ClinicalTrials.gov) | July 2015 | 8/6/2015 | Effects of ODM-109 on Respiratory Function in Patients With Amyotrophic Lateral Sclerosis | Effects of ODM-109 on Respiratory Function in Patients With ALS. A Randomized, Double Blind, Placebo-controlled, Cross-over, 3-period, Multicenter Study With Open-label Follow-up Extension | Amyotrophic Lateral Sclerosis | Drug: ODM-109;Drug: Placebo for ODM-109 | Orion Corporation, Orion Pharma | NULL | Completed | 18 Years | N/A | All | 66 | Phase 2 | Germany;Ireland;Netherlands;United Kingdom |
| 387 | EUCTR2014-004567-21-IE (EUCTR) | 05/06/2015 | 05/03/2015 | Effects of ODM-109 on respiratory function in patients with ALS. | Effects of ODM-109 on respiratory function in patients with ALS. A randomised, double blind, placebo-controlled, cross-over, 3-period, multicentre study with open-label follow-up extension - LEVALS | Amyotrophic lateral sclerosis (ALS). A rapidly progressive neurological disease characterized by degeneration of upper and lower motor neurons with subsequent muscle atrophy and weakness and loss of respiratory function. The latter is due to the weakness and loss of the diaphragm muscle strength. MedDRA version: 19.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ODM-109 capsule 1 mg INN or Proposed INN: LEVOSIMENDAN | Orion Corporation Orion Pharma | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 2 | Ireland;Netherlands;Germany;United Kingdom | ||
| 388 | NCT02450552 (ClinicalTrials.gov) | June 2015 | 19/5/2015 | Clinical Trial of Ezogabine (Retigabine) in ALS Subjects | A Phase 2 Pharmacodynamic Trial of Ezogabine (Retigabine) on Neuronal Excitability in Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis | Drug: Ezogabine;Drug: Placebo | Brian Wainger | ALS Association;GlaxoSmithKline;Harvard University;Massachusetts General Hospital | Completed | 18 Years | 80 Years | All | 65 | Phase 2 | United States |
| 389 | EUCTR2014-004567-21-GB (EUCTR) | 27/05/2015 | 10/03/2015 | Effects of ODM-109 on respiratory function in patients with ALS. | Effects of ODM-109 on respiratory function in patients with ALS. A randomised, double blind, placebo-controlled, cross-over, 3-period, multicentre study with open-label follow-up extension - LEVALS | Amyotrophic lateral sclerosis (ALS). A rapidly progressive neurological disease characterized by degeneration of upper and lower motor neurons with subsequent muscle atrophy and weakness and loss of respiratory function. The latter is due to the weakness and loss of the diaphragm muscle strength. MedDRA version: 17.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ODM-109 capsule 1 mg INN or Proposed INN: LEVOSIMENDAN | Orion Corporation Orion Pharma | NULL | Not Recruiting | Female: yes Male: yes | 70 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Ireland;Netherlands;Germany;United Kingdom | ||
| 390 | EUCTR2010-024423-24-IT (EUCTR) | 05/05/2015 | 04/02/2014 | Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS) | Studio prospettico, multicentrico, randomizzato, in doppio cieco, controllato verso placebo, a gruppi paralleli, di fase 2/3 sull'efficacia e la sicurezza di masitinib a confronto con placebo nel trattamento di pazienti affetti da Sclerosi Laterale Amiotrofica (SLA) - AB10015 | patients suffering from Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 18.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Masitinib Product Code: AB1010 INN or Proposed INN: Masitinib Mesylate Other descriptive name: MASITINIB MESYLATE INN or Proposed INN: Masitinib Mesylate Other descriptive name: MASITINIB MESYLATE | AB SCIENCE | NULL | Not Recruiting | Female: yes Male: yes | 381 | Phase 2;Phase 3 | Romania;Netherlands;Germany;Portugal;Serbia;Slovakia;Greece;Spain;Ireland;Colombia;Italy;United Kingdom;France;Hungary;Mexico;Argentina | ||
| 391 | NCT02116634 (ClinicalTrials.gov) | May 2015 | 6/4/2014 | Mesenchymal Stem Cell Injection in Amyotrophic Lateral Sclerosis | Phase 1, 2 Study of Mesenchymal Stem Cells Injection in ALS (Amyotrophic Lateral Sclerosis) Patients | Amyotrophic Lateral Sclerosis | Biological: mesenchymal stem cell | Alzahra Hospital, Iran | NULL | Withdrawn | 18 Years | 60 Years | Both | 0 | Phase 1/Phase 2 | Iran, Islamic Republic of |
| 392 | NCT02987413 (ClinicalTrials.gov) | April 28, 2015 | 1/7/2016 | Escalated Application of Mesenchymal Stem Cells in Amyotrophic Lateral Sclerosis Patients | Safety and Efficacy of Mesenchymal Stem Cells Escalated Application in Amyotrophic Lateral Sclerosis Patients: Study Design of a Phase I Trial | Motor Neuron Disease | Biological: Autologous Mesenchymal stem cells (MSCs) | Hospital e Maternidade Dr. Christóvão da Gama | IEP São Lucas - Instituto de Ensino e Pesquisa;Clinica Jordy Sinapse;TECHLIFE - Centro de Tecnologia Celular | Completed | 18 Years | N/A | All | 3 | Phase 1 | Brazil |
| 393 | EUCTR2010-024423-24-HU (EUCTR) | 21/04/2015 | 31/10/2014 | Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS) | A prospective, multicenter, randomized, double-blind, placebocontrolled, parallel groups, phase 2/3 study to compare the efficacy and safety of masitinib versus placebo in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - not applicable | patients suffering from Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 17.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: na INN or Proposed INN: Masitinib mesylate Other descriptive name: na Product Name: masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: na INN or Proposed INN: Masitinib mesylate Other descriptive name: na | ABScience | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2;Phase 3 | United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ireland;Israel;Colombia;United Kingdom;Italy;France;Hungary;Czech Republic;Mexico;Argentina;Poland;Belgium;Romania;Germany;Netherlands | ||
| 394 | EUCTR2010-024423-24-PT (EUCTR) | 10/04/2015 | 03/11/2014 | Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS) | A prospective, multicenter, randomized, double-blind, placebocontrolled, parallel groups, phase 2/3 study to compare the efficacy and safety of masitinib versus placebo in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - not applicable | patients suffering from Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 20.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: na INN or Proposed INN: Masitinib mesylate Other descriptive name: na Product Name: masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: na INN or Proposed INN: Masitinib mesylate Other descriptive name: na | ABScience | NULL | Not Recruiting | Female: yes Male: yes | 381 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;Slovakia;Greece;Spain;Ireland;Colombia;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Argentina;Romania;Netherlands;Germany | ||
| 395 | NCT02463825 (ClinicalTrials.gov) | April 2015 | 21/4/2015 | A Registry-Based Clinical Trial of Pimozide in Patients With Neuromuscular Junction Transmission Dysfunction Due to ALS | A Registry-Based Randomized-Controlled, Double-Blinded Clinical Trial of Pimozide in Patients With Neuromuscular Junction Transmission Dysfunction Due to Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis (ALS) | Drug: Pimozide 2 mg per day;Drug: Pimozide 4 mg per day;Drug: Placebo (Lactose tablet) | University of Calgary | Hotchkiss Brain Institute, University of Calgary | Active, not recruiting | 18 Years | N/A | Both | 25 | Phase 2 | Canada |
| 396 | EUCTR2010-024423-24-GR (EUCTR) | 06/03/2015 | 21/11/2013 | Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS) | A prospective, multicenter, randomized, double-blind, placebocontrolled, parallel groups, phase 2/3 study to compare the efficacy and safety of masitinib versus placebo in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - not applicable | Patients suffering from Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 17.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: na Product Name: masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: na | ABScience | NULL | Not Recruiting | Female: yes Male: yes | 381 | Phase 2;Phase 3 | United States;Portugal;Slovakia;Greece;Spain;Ireland;United Kingdom;Italy;France;Czech Republic;Hungary;Argentina;Netherlands;Germany | ||
| 397 | NCT02405403 (ClinicalTrials.gov) | March 2015 | 2/3/2015 | Microglial Activation Role In ALS (MARIA) | Microglial Activation Role In ALS (MARIA) | Amyotrophic Lateral Sclerosis | Drug: [18F]DPA-714 PET | University Hospital, Tours | NULL | Withdrawn | 18 Years | N/A | All | 0 | Early Phase 1 | France |
| 398 | JPRN-UMIN000016352 | 2015/02/01 | 01/02/2015 | The Safety of Edaravone for patients with Amyotrophic Lateral Sclerosis: Single centered open label trial | The Safety of Edaravone for patients with Amyotrophic Lateral Sclerosis: Single centered open label trial - The Safety of Edaravone for patients with Amyotrophic Lateral Sclerosis | amyotrophic lateral sclerosis | edaravone | Ehime University Hospital | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 10 | Phase 1,2 | Japan |
| 399 | NCT02414230 (ClinicalTrials.gov) | February 2015 | 7/4/2015 | F 18 T807 Tau PET Imaging in Familial Amyotrophic Lateral Sclerosis | F 18 T807 Tau PET Imaging in Familial Amyotrophic Lateral Sclerosis (IND 123119 Protocol B) | Amyotrophic Lateral Sclerosis (ALS) | Drug: Drug: F 18 T807 | Tammie L. S. Benzinger, MD, PhD | NULL | Completed | 18 Years | N/A | All | 9 | United States | |
| 400 | NCT02306590 (ClinicalTrials.gov) | February 2015 | 1/12/2014 | Efficacy, Safety and Tolerability of High Lipid and Calorie Supplementation in Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis | Dietary Supplement: Calogen;Dietary Supplement: Placebo | University of Ulm | NULL | Completed | 18 Years | N/A | All | 207 | N/A | Germany | |
| 401 | NCT02269436 (ClinicalTrials.gov) | January 2015 | 8/10/2014 | A follow-on Study to Assess Long-term Safety and Tolerability of i.c.v Administration of sNN0029 in Patients With ALS | A Multi-centre, Open-label, follow-on Study to Assess Long-term Safety and Tolerability of Intracerebroventricular Administration of sNN0029 in Patients With Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis | Drug: sNN0029 infusion solution | Newron Sweden AB | NULL | Terminated | 18 Years | 75 Years | Both | 11 | Phase 1 | Belgium;Netherlands |
| 402 | NCT02288091 (ClinicalTrials.gov) | January 2015 | 5/11/2014 | A Pilot Study of Inosine in Amyotrophic Lateral Sclerosis (ALS) | A Pilot Study of Inosine in Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis | Drug: Inosine | Massachusetts General Hospital | The Salah Foundation;MGH cure ALS Fund | Completed | 18 Years | N/A | All | 32 | Phase 1 | United States |
| 403 | ChiCTR-IOR-14005674 | 2014-12-30 | 2014-12-09 | Open randomized controlled trial of the Jianpi Yifei Decoction in the treatment of bulbar paralysis of amyotrophic lateral sclerosis | Open randomized controlled trial of the Jianpi Yifei Decoction in the treatment of bulbar paralysis of amyotrophic lateral sclerosis | amyotrophic lateral sclerosis | Chinese medicine :Jianpi Yifei Decoction ;Riluzole:Riluzole; | Guangdong Province Traditional Chinese Medical Hospital | NULL | Pending | 18 | 80 | Both | Chinese medicine :30;Riluzole:30; | China | |
| 404 | NCT02286011 (ClinicalTrials.gov) | November 2014 | 24/10/2014 | Intramuscular Infusion of Autologous Bone Marrow Stem Cells in Patients With Amyotrophic Lateral Sclerosis | Phase I Clinical Trial on Intramuscular Infusion of Autologous Bone Marrow Stem Cells in Patients With Amyotrophic Lateral Sclerosis. | ALS (Amyotrophic Lateral Sclerosis) | Biological: MNC (Mononuclear cells);Other: Saline | Red de Terapia Celular | Spanish National Health System;Hospital Universitario Virgen de la Arrixaca;Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia;Public Health Service, Murcia;Instituto Murciano de Investigación Biosanitaria Virgen de la Arrixaca | Active, not recruiting | 18 Years | 70 Years | All | 20 | Phase 1 | Spain |
| 405 | NCT02479802 (ClinicalTrials.gov) | November 2014 | 10/6/2015 | Efficacy and Safety of Plasma Exchange With Albumin in Patients With Amyotrophic Lateral Sclerosis | Pilot Study on the Effects of Plasma Exchange on Motor Dysfunction and Cognitive Function in Patients With Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis | Biological: Albumin | Instituto Grifols, S.A. | NULL | Completed | 18 Years | 70 Years | All | 13 | Phase 2 | Spain |
| 406 | JPRN-UMIN000015054 | 2014/09/21 | 04/09/2014 | An investigator initiated clinical trial in healthy adults to evaluate safety and pharmacokinetics of WN1316, a candidate drug of amyotrophic lateral sclerosis | An investigator initiated clinical trial in healthy adults to evaluate safety and pharmacokinetics of WN1316, a candidate drug of amyotrophic lateral sclerosis - An investigator initiated clinical trial in healthy adults of WN1316 | Amyotrophic Lateral Sclerosis (ALS) | WN1316 solution 5mL is administered single dose orally. The dosage of WN1316 is 60 micrograms in step 1, 180 micrograms in step 2, 600 micrograms in step 3. Placebo (Distilled water) 5 mL is administered single dose orally. | Clinical Research Hospital Tokyo | NULL | Complete: follow-up complete | 20years-old | 35years-old | Male | 24 | Not selected | Japan |
| 407 | EUCTR2012-002099-15-SE (EUCTR) | 15/09/2014 | 01/08/2014 | Safety and Efficacy of Apovir for treatment of patients with ALS (Amyotrophic lateral sclerosis) | A randomised, double blind, placebo controlled trial to evaluate the safety and efficacy of Apovir for treatment of patients with Amyotrophic lateral sclerosis | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 17.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Pleconaril Product Code: APO-P001 INN or Proposed INN: PLECONARIL Trade Name: Copegus Product Name: Ribavirin Other descriptive name: RIBAVIRIN | Apodemus AB | NULL | Not Recruiting | Female: yes Male: yes | Phase 2 | Sweden | |||
| 408 | EUCTR2014-002228-28-IT (EUCTR) | 01/09/2014 | 12/06/2014 | STEMALS-II | A double blind, placebo controlled, parallel groups, multicenter study on filgrastim in amyotrophic lateral sclerosis - STEMALS-II | Amyotrophic lateral sclerosis (ALS) is a severe progressive neurological disorder characterized by a selective degeneration of spinal, bulbar, and cortical motor neurons.;Therapeutic area: Not possible to specify | Trade Name: TEVAGRASTIM Product Name: filgrastim Trade Name: MANNITOLO 18% LDB Product Name: MANNITOLO 18% Trade Name: PERFALGAN Product Name: PARACETAMOLO | Università degli Studi di Torino e Azienda Ospedaliera Città della Salute e della Scienza di Torino | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 2 | Italy | ||
| 409 | NCT01999803 (ClinicalTrials.gov) | September 2014 | 22/11/2013 | A Safety Study of sNN0029 Administration Via Intracerebroventricular Route to Patients With ALS | A Phase I, Randomised, Double-blind, Placebo-controlled Study in Patients With Amyotrophic Lateral Sclerosis to Further Assess the Safety and Tolerability of Intracerebroventricular Administration of sNN0029 Infusion Solution | Amyotrophic Lateral Sclerosis | Drug: sNN0029;Drug: Placebo | Newron Sweden AB | NULL | Terminated | 18 Years | 75 Years | Both | 15 | Phase 1 | Belgium;Netherlands |
| 410 | NCT02492516 (ClinicalTrials.gov) | September 2014 | 24/6/2015 | Intravenous Injection of Adipose Derived Mesenchymal Stem Cell for ALS | Evaluation the Safety of Intravenous Injection of Adipose Derived Mesenchymal Stem Cell in Patients With ALS | Amyotrophic Lateral Sclerosis | Biological: mesenchymal stem cells | Royan Institute | NULL | Completed | 18 Years | 55 Years | All | 19 | Phase 1 | Iran, Islamic Republic of |
| 411 | NCT02238626 (ClinicalTrials.gov) | September 2014 | 4/9/2014 | Ibudilast (MN-166) in Subjects With Amyotrophic Lateral Sclerosis (ALS) | A Single-center, Randomized, Double-blind, Placebo-controlled, 6-month Trial Followed by an Open-label Extension to Evaluate the Safety, Tolerability and Clinical Endpoint Responsiveness of Ibudilast (MN-166) in Subjects With (ALS) | Amyotrophic Lateral Sclerosis | Drug: Placebo (for MN-166);Drug: MN-166;Drug: riluzole | MediciNova | Atrium Health | Completed | 18 Years | 80 Years | All | 71 | Phase 2 | United States |
| 412 | NCT02236065 (ClinicalTrials.gov) | August 2014 | 8/9/2014 | Combination Therapy of Cord Blood and G-CSF for Patients With Brain Injury or Neurodegenerative Disorders | A Pilot Study of Combination Therapy of Allogeneic Umbilical Cord Blood and Granulocyte-colony Stimulating Factor for Patients With Brain Injury or Neurodegenerative Disorders | Brain Injury;Cerebral Palsy;Amyotrophic Lateral Sclerosis;Parkinson's Disease | Procedure: Umbilical cord blood therapy;Biological: Filgrastim | MinYoung Kim, M.D. | NULL | Completed | 19 Years | 75 Years | All | 10 | N/A | Korea, Republic of |
| 413 | EUCTR2011-004801-25-ES (EUCTR) | 16/07/2014 | 11/01/2013 | CLINICAL TRIAL ON THE USE OF BONE MARROW OWN PATIENT'S WITH AMYOTROPHIC LATERAL SCLEROSIS | A PHASE I/II CLINICAL TRIAL OF THE BONE MARROW'S AUTOLOGOUS STEM CELLS IN PATIENTS WITH AMYOTROPHIC LATERAL SCLEROSIS | amyotrophic lateral sclerosis MedDRA version: 15.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: células troncales hematopoyéticas autólogas adultas extraidas de médula ósea INN or Proposed INN: autologous bone marrow mononucleated cells Other descriptive name: autologous bone marrow mononucleated cells | Fundación Sanitaria para el Fomento de la Investigación Sanitaria y Biomédica de la Comunidad Valenciana (FISABIO) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 1/2 | Spain | |||
| 414 | NCT02290886 (ClinicalTrials.gov) | July 2014 | 9/10/2014 | A Multicenter Phase I/II Clinical Trial to Evaluate Safety of Mesenchymal Stem Cell in Patients With Amyotrophic Sclerosis Lateral | A Multicenter Phase I/II Clinical Trial, Randomized, Controlled With Placebo, Triple Blind to Evaluate Safety, and Indications of Efficiency of the Intravenous Administration of the Therapy With 3 Doses of MSC in Patients With ASL Moderated to Severe | Amyotrophic Lateral Sclerosis | Other: Intravenous administration of placebo;Drug: Intravenous administration of 1 million of MSC;Drug: Intravenous administration of 2 million of MSC;Drug: Intravenous administration of 4 million of MSC | Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud | Iniciativa Andaluza en Terapias Avanzadas | Completed | 18 Years | N/A | All | 52 | Phase 1/Phase 2 | Spain |
| 415 | NCT02152449 (ClinicalTrials.gov) | July 2014 | 28/5/2014 | Oral Nutritional Supplementation in Amyotrophic Lateral Sclerosis (ALS) Patients | Impact on Functional Status of Early Oral Nutritional Supplementation (ONS) in Amyotrophic Lateral Sclerosis (ALS) Patients | Amyotrophic Lateral Sclerosis (ALS) | Dietary Supplement: Oral nutritional supplementation | University Hospital, Limoges | Laboratoires NUTRICIA | Completed | 18 Years | N/A | All | 229 | N/A | France |
| 416 | NCT03367650 (ClinicalTrials.gov) | May 13, 2014 | 28/11/2017 | Epidemiology and Genetics of the Amyotrophic Lateral Sclerosis in the French West Indies | Epidemiology and Genetics of the Amyotrophic Lateral Sclerosis in the French West Indies | Amyotrophic Lateral Sclerosis | Dietary Supplement: Blood sample and environmental survey | Centre Hospitalier Universitaire de Pointe-a-Pitre | NULL | Recruiting | 18 Years | N/A | All | 70 | N/A | Guadeloupe;Martinique |
| 417 | EUCTR2013-004842-40-ES (EUCTR) | 09/05/2014 | 07/03/2014 | Pilot study to evaluate the effect of plasma exchange with albumin in patients with amyotrophic lateral sclerosis | Pilot study to evaluate the effect of plasma exchange in motor and cognitive function in patients with amyotrophic lateral sclerosis - Albumin in ALS | Amytrophic Lateral Sclerosis (ALS) MedDRA version: 16.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Albutein 5% INN or Proposed INN: albúmina humana Other descriptive name: HUMAN ALBUMIN SOLUTION | Instituto Grifols S.A. | NULL | Not Recruiting | Female: yes Male: yes | Phase 4 | Spain | |||
| 418 | NCT02017912 (ClinicalTrials.gov) | May 2014 | 17/12/2013 | Phase 2, Randomized, Double Blind, Placebo Controlled Multicenter Study of Autologous MSC-NTF Cells in Patients With ALS | A Phase 2, Randomized, Double Blind, Placebo Controlled Multicenter Study to Evaluate Safety and Efficacy of Transplantation of Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors (MSC-NTF) in Patients With ALS | Amyotrophic Lateral Sclerosis (ALS) | Biological: Autologous MSC-NTF cells;Biological: Placebo | Brainstorm-Cell Therapeutics | NULL | Completed | 18 Years | 75 Years | All | 48 | Phase 2 | United States |
| 419 | EUCTR2010-024423-24-SK (EUCTR) | 07/04/2014 | 05/12/2013 | Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS) | A prospective, multicenter, randomized, double-blind, placebocontrolled, parallel groups, phase 2/3 study to compare the efficacy and safety of masitinib versus placebo in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - not applicable | patients suffering from Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 20.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: na INN or Proposed INN: Masitinib mesylate Other descriptive name: na Product Name: masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: na INN or Proposed INN: Masitinib mesylate Other descriptive name: na | ABScience | NULL | Not Recruiting | Female: yes Male: yes | 381 | Phase 2;Phase 3 | Portugal;United States;Serbia;Slovakia;Greece;Spain;Ireland;Colombia;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Argentina;Romania;Netherlands;Germany | ||
| 420 | NCT02166944 (ClinicalTrials.gov) | April 2014 | 9/6/2014 | Tamoxifen Treatment in Patients With Motor Neuron Disease | The Study of Tamoxifen Treatment in Patients With Motor Neuron Disease | Amyotrophic Lateral Sclerosis;ALS Functional Ration Scale;TAR-DNA-binding Protein-43;Tamoxifen;mTOR | Drug: tamoxifen 40 mg daily for one year | Taipei Medical University Shuang Ho Hospital | NULL | Completed | 20 Years | 80 Years | All | 20 | Phase 1/Phase 2 | Taiwan |
| 421 | NCT01759784 (ClinicalTrials.gov) | March 2014 | 29/12/2012 | Intraventricular Transplantation of Mesenchymal Stem Cell in Patients With ALS | Safety of Intraventricular Injection of Bone Marrow Derived Mesenchymal Stem Cell in Patients With ALS | Amyotrophic Lateral Sclerosis | Biological: Intraventricular injection | Royan Institute | NULL | Withdrawn | 18 Years | 70 Years | Both | 0 | Phase 1 | Iran, Islamic Republic of |
| 422 | NCT02039401 (ClinicalTrials.gov) | February 2014 | 15/1/2014 | Safety Study of VM202 to Treat Amyotrophic Lateral Sclerosis | A Phase I/II, Open Label Study to Assess the Safety and Tolerability of VM202 in Subjects With Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis | Biological: VM202 | Helixmith Co., Ltd. | NULL | Completed | 21 Years | 75 Years | All | 18 | Phase 1/Phase 2 | United States |
| 423 | NCT02645461 (ClinicalTrials.gov) | January 2014 | 22/12/2015 | Acetylcholine Receptors From Human Muscles as Pharmacological Target for ALS | Acetylcholine Receptors From Human Muscles as Pharmacological Target for ALS | Amyotrophic Lateral Sclerosis | Drug: endocannabinoid palmitoylethanolamide (PEA);Drug: Riluzole | University of Roma La Sapienza | NULL | Completed | 18 Years | N/A | Both | 50 | N/A | NULL |
| 424 | NCT01786603 (ClinicalTrials.gov) | November 21, 2013 | 28/11/2012 | Rasagiline in Subjects With Amyotrophic Lateral Sclerosis (ALS) | Phase 2 Study of Rasagiline for Treatment of Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis (ALS) | Drug: Rasagiline;Drug: Placebo | Richard Barohn, MD | NULL | Completed | 21 Years | 80 Years | All | 80 | Phase 2 | United States |
| 425 | NCT01884571 (ClinicalTrials.gov) | October 2013 | 19/6/2013 | Immunosuppression in Amyotrophic Lateral Sclerosis (ALS) | A Novel Immunosuppression Intervention for the Treatment of Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis (ALS) | Drug: Basiliximab;Drug: Methylprednisolone;Drug: Prednisone;Drug: Tacrolimus;Drug: Mycophenolate mofetil | Emory University | ALS Association | Completed | 18 Years | N/A | All | 31 | Phase 2 | United States |
| 426 | JPRN-UMIN000011494 | 2013/09/02 | 02/09/2013 | Assessment of the efficacy and the influence on swallowing function of transdermal scopolamine for ALS patinets' drooling | Assessment of the efficacy and the influence on swallowing function of transdermal scopolamine for ALS patinets' drooling - SCOPOLA-D | amyotrophic lateral sclerosis | scopolamine patch 7days-washout 7days-placebo patch 7days placebo patch 7days-washout 7days-scopolamine patch 7days | Mie University Graduate school of medicine,Department of neurology | Matsusaka Chuou HospitalNational Mie Hospital | Complete: follow-up complete | Not applicable | Not applicable | Male and Female | 10 | Not applicable | Japan |
| 427 | NCT01935518 (ClinicalTrials.gov) | September 2013 | 1/9/2013 | A Clinical Trial of Safety and Efficacy of Fasudil in Subjects With Amyotrophic Lateral Sclerosis (ALS) | A Historical Placebo Controlled Screening Trial of Safety and Efficacy of Fasudil in Subjects With Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis | Drug: Fasudil | Peking University Third Hospital | NULL | Recruiting | 18 Years | 70 Years | Both | 10 | Phase 2 | China |
| 428 | NCT02164253 (ClinicalTrials.gov) | September 2013 | 20/5/2014 | Focal Accumulation of Iron in Cerebral Regions in Early ALS (Amyotrophic Lateral Sclerosis) Patients | Feasibility and Safety Pilot Therapeutic Study of the Iron Chelator Deferiprone in Amyotrophic Lateral Sclerosis | ALS (Amyotrophic Lateral Sclerosis);Iron Overload | Drug: Deferiprone | University Hospital, Lille | ApoPharma | Completed | 18 Years | 85 Years | All | 23 | Phase 2 | France |
| 429 | NCT01771640 (ClinicalTrials.gov) | August 2013 | 16/1/2013 | Intrathecal Transplantation of Mesenchymal Stem Cell in Patients With ALS | Intrathecal Transplantation of Autologous Bone Marrow Derived Mesenchymal Stem Cell in Patients With ALS | Amyotrophic Lateral Sclerosis | Biological: intrathecal injection | Royan Institute | NULL | Completed | 18 Years | 65 Years | All | 8 | Phase 1 | Iran, Islamic Republic of |
| 430 | NCT01786174 (ClinicalTrials.gov) | August 2013 | 4/2/2013 | Gilenya in Amyotrophic Lateral Sclerosis (ALS) | Phase IIa Double-Blind, Placebo-Controlled Study to Evaluate the Safety of Oral Fingolimod in Patients With Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis | Drug: Gilenya;Other: Placebo | Massachusetts General Hospital | ALS Therapy Development Institute | Completed | 18 Years | N/A | All | 30 | Phase 2 | United States |
| 431 | NCT01854294 (ClinicalTrials.gov) | August 2013 | 8/5/2013 | GM604 Phase 2A Randomized Double-blind Placebo Controlled Pilot Trial in Amyotrophic Lateral Disease (ALS) | GM604 Phase 2A Randomized Double-blind Placebo Controlled Pilot Trial in Amyotrophic Lateral Disease (ALS) | Amyotrophic Lateral Sclerosis | Drug: GM604;Drug: Placebo comparator | Genervon Biopharmaceuticals, LLC | Columbia University;Massachusetts General Hospital | Completed | 18 Years | N/A | All | 12 | Phase 2 | United States |
| 432 | NCT01849770 (ClinicalTrials.gov) | July 2013 | 6/5/2013 | Mexiletine in Sporadic Amyotrophic Lateral Sclerosis (SALS) | A Safety and Tolerability Study of Mexiletine in Patients With Sporadic Amyotrophic Lateral Sclerosis (SALS) | Sporadic Amyotrophic Lateral Sclerosis | Drug: Mexiletine;Drug: Placebo | University of Washington | NULL | Completed | 18 Years | N/A | All | 75 | Phase 2 | United States |
| 433 | NCT01906658 (ClinicalTrials.gov) | July 2013 | 15/7/2013 | A Study to Explore the Safety and Tolerability of Acthar in Patients With Amyotrophic Lateral Sclerosis | A Study to Explore the Safety and Tolerability of Acthar in Patients With Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis | Drug: Repository corticotropin injection | Mallinckrodt | NULL | Completed | 18 Years | 80 Years | All | 43 | Phase 2 | United States |
| 434 | EUCTR2012-004987-23-ES (EUCTR) | 12/06/2013 | 16/05/2013 | A study in which patients suffering from amyotrophic lateral sclerosis (ALS) may be assigned randomly to receive either the treatment or placebo to look at how safe the product is, whether it has an effect and is easy to take. | A Phase IIb, multi-national, double-blind, randomised, placebo-controlled study to evaluate the safety, tolerability and efficacy of CK-2017357 in patients with amyotrophic lateral sclerosis (ALS) | Amyotrophic lateral sclerosis MedDRA version: 16.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Tirasemtiv Product Code: CK2017357 INN or Proposed INN: Tirasemtiv Other descriptive name: 6-ethynyl-1-(pentan-3-yl)-1H-imidazo[4,5-b]pyrazin-2(3H)-one Trade Name: Rilutek Product Name: Riluzole INN or Proposed INN: RILUZOLE | Cytokinetics Inc | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 2 | United States;France;Canada;Spain;Ireland;Netherlands;Germany;United Kingdom | ||
| 435 | NCT01879241 (ClinicalTrials.gov) | June 2013 | 12/6/2013 | Study of Rasagiline in Patients With Amyotrophic Lateral Sclerosis | Efficacy, Safety and Tolerability Study of 1 mg Rasagiline in Patients With Amyotrophic Lateral Sclerosis (ALS) Receiving Standard Therapy (Riluzole) - An AMG Trial With a Market Authorized Substance | Amyotrophic Lateral Sclerosis | Drug: Rasagiline;Drug: Placebo | University of Ulm | NULL | Completed | 18 Years | N/A | Both | 252 | Phase 2 | Germany |
| 436 | NCT01811355 (ClinicalTrials.gov) | May 2013 | 6/3/2013 | Mexiletine for the Treatment of Muscle Cramps in ALS | Mexiletine for the Treatment of Muscle Cramps in ALS | Muscle Cramps in Amyotrophic Lateral Sclerosis | Drug: Mexiletine;Drug: Placebo | Bjorn Oskarsson, MD | University of California, Davis;ALS Association | Completed | 21 Years | 89 Years | All | 23 | Phase 4 | United States |
| 437 | EUCTR2012-004987-23-DE (EUCTR) | 29/04/2013 | 17/01/2013 | A study in which patients suffering from amyotrophic lateral sclerosis (ALS) may be assigned randomly to receive either the treatment or placebo to look at how safe the product is, whether it has an effect and is easy to take. | A Phase IIb, multi-national, double-blind, randomised, placebo-controlled study to evaluate the safety, tolerability and efficacy of CK-2017357 in patients with amyotrophic lateral sclerosis (ALS) | Amyotrophic lateral sclerosis MedDRA version: 16.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Tirasemtiv Product Code: CK2017357 INN or Proposed INN: Tirasemtiv Other descriptive name: 6-ethynyl-1-(pentan-3-yl)-1H-imidazo[4,5-b]pyrazin-2(3H)-one Trade Name: Rilutek Product Name: Riluzole INN or Proposed INN: RILUZOLE | Cytokinetics Inc | NULL | Not Recruiting | Female: yes Male: yes | 700 | Phase 2 | United States;Canada;Spain;Ireland;Netherlands;Germany;United Kingdom | ||
| 438 | EUCTR2011-004482-32-DE (EUCTR) | 10/04/2013 | 21/12/2012 | Efficacy, Safety and Tolerability Study of 1 mg Rasagiline in Patients with Amyotrophic Lateral Sclerosis (ALS) Receiving Standard Therapy (Riluzole) | Efficacy, Safety and Tolerability Study of 1 mg Rasagiline in Patients with Amyotrophic Lateral Sclerosis (ALS) Receiving Standard Therapy (Riluzole) - RAS-ALS Trial | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 14.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: AZILECT® 1 mg Tabletten INN or Proposed INN: Rasagiline Mesilate Other descriptive name: RASAGILINE MESILATE | Universitätsklinikum Ulm | NULL | Not Recruiting | Female: yes Male: yes | Phase 2 | Germany | |||
| 439 | NCT01806857 (ClinicalTrials.gov) | April 2013 | 5/3/2013 | Clinical Trial Nuedexta in Subjects With ALS | The Experimental Treatment of Bulbar Dysfunction in Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis (ALS) | Drug: Nuedexta;Drug: Matching Placebo | Center for Neurologic Study, La Jolla, California, | ALS Association;State University of New York - Upstate Medical University | Completed | 18 Years | N/A | All | 90 | Phase 2 | United States |
| 440 | NCT02588677 (ClinicalTrials.gov) | April 2013 | 20/10/2015 | Masitinib in Combination With Riluzole for the Treatment of Patients Suffering From Amyotrophic Lateral Sclerosis (ALS) | Multicenter, Randomised, Double-blind, Placebo-controlled, Parallel Group, Phase 2/3 Study to Compare the Efficacy and Safety of Masitinib | Amyotrophic Lateral Sclerosis (ALS) | Drug: Masitinib (4.5);Drug: Riluzole;Drug: Placebo;Drug: Masitinib (3.0) | AB Science | NULL | Completed | 18 Years | N/A | All | 394 | Phase 2/Phase 3 | Spain |
| 441 | EUCTR2011-004798-99-DE (EUCTR) | 27/02/2013 | 27/12/2012 | Safety and Efficacy of SOD1 Inhibition By Pyrimethamine in Familial (ALS) | Safety and Efficacy of SOD1 Inhibition By Pyrimethamine in Familial (ALS) - Pyrimethamine In Familial ALS | Familial amyotrophic lateral sclerosis (FALS) MedDRA version: 14.1;Level: LLT;Classification code 10036704;Term: Primary lateral sclerosis;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Daraprim INN or Proposed INN: PYRIMETHAMINE | Weill Medical College of Cornell University | NULL | Not Recruiting | Female: yes Male: yes | 40 | United States;Germany;Italy | |||
| 442 | EUCTR2012-004987-23-IE (EUCTR) | 08/02/2013 | 30/11/2012 | A study in which patients suffering from amyotrophic lateral sclerosis (ALS) may be assigned randomly to receive either the treatment or placebo to look at how safe the product is, whether it has an effect and is easy to take. | A Phase IIb, multi-national, double-blind, randomised, placebo-controlled study to evaluate the safety, tolerability and efficacy of CK-2017357 in patients with amyotrophic lateral sclerosis (ALS) | Amyotrophic lateral sclerosis MedDRA version: 14.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Tirasemtiv Product Code: CK2017357 INN or Proposed INN: Tirasemtiv Other descriptive name: 6-ethynyl-1-(pentan-3-yl)-1H-imidazo[4,5-b]pyrazin-2(3H)-one Trade Name: Rilutek Product Name: Riluzole INN or Proposed INN: RILUZOLE | Cytokinetics Inc | NULL | Not Recruiting | Female: yes Male: yes | 700 | Phase 2 | United States;Canada;Spain;Ireland;Netherlands;Germany;United Kingdom | ||
| 443 | EUCTR2011-006254-85-ES (EUCTR) | 08/02/2013 | 09/08/2012 | Clinical trial to value the safety and efficacy of administration of stem cells derived from own patient for the treatment of Amyotrophic Lateral Sclerosis (ALS). | Placebo controlled, randomized and triple blind multicentric phase I/II clinical trial to evaluate the safety, feasibility and valoration of efficacy trends of intravenous administration of three doses of autologous adipose derived autologous mesenchymal stem cells (CeTMAd) in moderate/severe ALS patients. | Amyotrophic lateral sclerosis (ALS) MedDRA version: 14.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Células madre mesenquimales de tejido adiposo autólogo INN or Proposed INN: NA Other descriptive name: Células Mesenquimales de tejido adiposo | FUNDACIÓN PROGRESO Y SALUD | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 1/2 | Spain | |||
| 444 | EUCTR2010-024423-24-ES (EUCTR) | 29/01/2013 | 29/11/2012 | Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS) | A prospective, multicenter, randomized, double-blind, placebocontrolled, parallel group, phase 2 study to compare the efficacy and safety of masitinib versus placebo in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - not applicable | patients suffering from Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 14.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: na Product Name: masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: MASITINIB | ABScience | NULL | Not Recruiting | Female: yes Male: yes | 45 | Phase 2 | Portugal;France;Hungary;Slovakia;Greece;Spain;Ireland;Netherlands;Italy | ||
| 445 | EUCTR2012-004987-23-GB (EUCTR) | 24/01/2013 | 12/12/2012 | A study in which patients suffering from amyotrophic lateral sclerosis (ALS) may be assigned randomly to receive either the treatment or placebo to look at how safe the product is, whether it has an effect and is easy to take. | A Phase IIb, multi-national, double-blind, randomised, placebo-controlled study to evaluate the safety, tolerability and efficacy of CK-2017357 in patients with amyotrophic lateral sclerosis (ALS) | Amyotrophic lateral sclerosis MedDRA version: 14.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Tirasemtiv Product Code: CK2017357 INN or Proposed INN: Tirasemtiv Other descriptive name: 6-ethynyl-1-(pentan-3-yl)-1H-imidazo[4,5-b]pyrazin-2(3H)-one Trade Name: Rilutek Product Name: Riluzole INN or Proposed INN: RILUZOLE | Cytokinetics Inc | NULL | Not Recruiting | Female: yes Male: yes | 700 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Canada;Spain;Ireland;Netherlands;Germany;United Kingdom | ||
| 446 | EUCTR2012-003349-13-DE (EUCTR) | 15/01/2013 | 12/12/2012 | A Study of Ozanezumab (GSK1223249) versus Placebo in the Treatment of Amyotrophic Lateral Sclerosis (ALS) | Study NOG112264, a Phase II Study of Ozanezumab(GSK1223249) versus Placebo in the Treatment of AmyotrophicLateral Sclerosis - Ozanezumab Phase II study in patients with ALS | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 14.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ozanezumab Product Code: GSK1223249 INN or Proposed INN: Ozanezumab Other descriptive name: Immunoglobulin G1, anti (protein Nogo A) (human Mus musculus monoclonal heavy chain), disulfide with human Mus musculus monoclonal light chain, dimer | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 294 | Phase 2 | France;United States;Canada;Belgium;Australia;Netherlands;Germany;United Kingdom;Italy;Japan;Korea, Republic of | ||
| 447 | EUCTR2012-003349-13-NL (EUCTR) | 15/01/2013 | 12/11/2012 | A Study of Ozanezumab (GSK1223249) versus Placebo in the Treatment of Amyotrophic Lateral Sclerosis (ALS) | Study NOG112264, a Phase II Study of Ozanezumab(GSK1223249) versus Placebo in the Treatment of AmyotrophicLateral Sclerosis - Ozanezumab Phase II study in patients with ALS | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 14.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ozanezumab Product Code: GSK1223249 INN or Proposed INN: Ozanezumab Other descriptive name: Immunoglobulin G1, anti (protein Nogo A) (human Mus musculus monoclonal heavy chain), disulfide with human Mus musculus monoclonal light chain, dimer | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 294 | Phase 2 | France;United States;Canada;Belgium;Australia;Germany;Netherlands;United Kingdom;Italy;Japan;Korea, Republic of | ||
| 448 | NCT01776970 (ClinicalTrials.gov) | January 2013 | 24/1/2013 | Safety and Efficacy on Spasticity Symptoms of a Cannabis Sativa Extract in Motor Neuron Disease | A Fase II, Randomized, Double-Blind, Placebo-Controlled, Multicentre Study for the Safety and Efficacy on Spasticity Symptoms of a Cannabis Sativa Extract in Motor Neuron Disease Patients | Motor Neuron Disease;Amyotrophic Lateral Sclerosis (ALS) | Drug: Cannabis Sativa extract Oromucosal spray | Ospedale San Raffaele | Fondazione Salvatore Maugeri;Niguarda Hospital;University of Padova | Completed | 18 Years | 80 Years | All | 60 | Phase 2/Phase 3 | Italy |
| 449 | NCT01759797 (ClinicalTrials.gov) | January 2013 | 31/12/2012 | Intravenous Transplantation of Mesenchymal Stem Cell in Patients With ALS | Safety of Intravenous Transplantation of Bone Marrow Derived Mesenchymal Stem Cell in Patients With ALS | Amyotrophic Lateral Sclerosis | Biological: intra venous injection of stem cell | Royan Institute | NULL | Completed | 18 Years | 65 Years | Both | 6 | Phase 1 | Iran, Islamic Republic of |
| 450 | NCT01835782 (ClinicalTrials.gov) | January 2013 | 27/3/2013 | Determining the Safety of L-serine in ALS | Determining the Safety of L-Serine in Subjects With Amyotrophic Lateral Sclerois (ALS) at Varied Doses. | Amyotrophic Lateral Sclerosis (ALS) | Drug: L-Serine | Phoenix Neurological Associates, LTD | Institute for Ethnomedicine | Active, not recruiting | 18 Years | 85 Years | Both | 20 | Phase 1/Phase 2 | United States |
| 451 | EUCTR2012-003349-13-GB (EUCTR) | 19/12/2012 | 18/12/2012 | A Study of Ozanezumab (GSK1223249) versus Placebo in the Treatment of Amyotrophic Lateral Sclerosis (ALS) | Study NOG112264, a Phase II Study of Ozanezumab (GSK1223249) versus Placebo in the Treatment of Amyotrophic Lateral Sclerosis - Ozanezumab Phase II study in patients with ALS | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 14.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ozanezumab Product Code: GSK1223249 INN or Proposed INN: Ozanezumab Other descriptive name: Immunoglobulin G1, anti (protein Nogo A) (human Mus musculus monoclonal heavy chain), disulfide with human Mus musculus monoclonal light chain, dimer | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 294 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;United States;Canada;Belgium;Australia;Germany;Netherlands;Italy;Japan;United Kingdom;Korea, Republic of | ||
| 452 | EUCTR2012-003349-13-FR (EUCTR) | 17/12/2012 | 20/06/2013 | A Study of Ozanezumab (GSK1223249) versus Placebo in the Treatment of Amyotrophic Lateral Sclerosis (ALS) | Study NOG112264, a Phase II Study of Ozanezumab (GSK1223249) versus Placebo in the Treatment of Amyotrophic Lateral Sclerosis - Ozanezumab Phase II study in patients with ALS | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 14.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ozanezumab Product Code: GSK1223249 INN or Proposed INN: Ozanezumab Other descriptive name: Immunoglobulin G1, anti (protein Nogo A) (human Mus musculus monoclonal heavy chain), disulfide with human Mus musculus monoclonal light chain, dimer | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 294 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;France;Canada;Belgium;Australia;Germany;Netherlands;United Kingdom;Italy;Japan;Korea, Republic of | ||
| 453 | EUCTR2012-003349-13-BE (EUCTR) | 06/12/2012 | 02/10/2012 | A Study of Ozanezumab (GSK1223249) versus Placebo in the Treatment of Amyotrophic Lateral Sclerosis (ALS) | Study NOG112264, a Phase II Study of Ozanezumab(GSK1223249) versus Placebo in the Treatment of AmyotrophicLateral Sclerosis - Ozanezumab Phase II study in patients with ALS | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 15.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ozanezumab Product Code: GSK1223249 INN or Proposed INN: Ozanezumab Other descriptive name: Immunoglobulin G1, anti (protein Nogo A) (human Mus musculus monoclonal heavy chain), disulfide with human Mus musculus monoclonal light chain, dimer | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 294 | Phase 2 | Australia;Germany;Netherlands;United Kingdom;France;United States;Canada;Belgium;Italy;Japan;Korea, Republic of | ||
| 454 | EUCTR2012-003349-13-IT (EUCTR) | 03/12/2012 | 11/12/2012 | a Phase II Study of Ozanezumab(GSK1223249) versus Placebo in the Treatment of AmyotrophicLateral Sclerosis | Study NOG112264, a Phase II Study of Ozanezumab(GSK1223249) versus Placebo in the Treatment of AmyotrophicLateral Sclerosis - Ozanezumab Phase II study in patients with ALS | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 14.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ozanezumab Product Code: GSK1223249 Other descriptive name: Immunoglobulin G1, anti (protein Nogo A) (human Mus musculus monoclonal heavy | GLAXOSMITHKLINE RESEARCH & DEVELOPMENT LTD. | NULL | Not Recruiting | Female: yes Male: yes | 294 | Phase 2 | France;United States;Canada;Belgium;Australia;Germany;Netherlands;United Kingdom;Japan;Italy;Korea, Republic of | ||
| 455 | NCT01753076 (ClinicalTrials.gov) | December 1, 2012 | 17/12/2012 | Study of Ozanezumab (GSK1223249) Versus Placebo in the Treatment of Amyotrophic Lateral Sclerosis | Study NOG112264, a Phase II Study of Ozanezumab (GSK1223249) Versus Placebo in the Treatment of Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis | Drug: Ozanezumab;Drug: Placebo | GlaxoSmithKline | NULL | Completed | 18 Years | 80 Years | All | 304 | Phase 2 | United States;Australia;Belgium;Canada;France;Germany;Italy;Japan;Korea, Republic of;Netherlands;United Kingdom |
| 456 | NCT01758510 (ClinicalTrials.gov) | December 2012 | 10/12/2012 | Safety Study of HLA-haplo Matched Allogenic Bone Marrow Derived Stem Cell Treatment in Amyotrophic Lateral Sclerosis | An Open-label, Phase 1 Trial for Safety Study of HLA-haplo Matched Allogenic Bone Marrow Derived Stem Cell(HYNR-CS-Allo Inj) Treatment in Amyotrophic Lateral Sclerosis(ALS) | Amyotrophic Lateral Sclerosis;Motor Neuron Disease;Neuromuscular Disease;Neurodegenerative Disease;Central Nervous System Disease | Genetic: HYNR-CS-Allo | Hanyang University Seoul Hospital | Corestem, Inc. | Completed | 25 Years | 80 Years | All | 6 | Phase 1 | Korea, Republic of |
| 457 | NCT01777646 (ClinicalTrials.gov) | December 2012 | 12/12/2012 | Autologous Mesenchymal Bone Marrow Stromal Cells Secreting Neurotrophic Factors (MSC-NTF), in Patients With Amyotrophic Lateral Sclerosis (ALS) | A Phase IIa, Open Label, Dose-escalating Clinical Study to Evaluate the Safety, Tolerability and Therapeutic Effects of Transplantation of Autologous Mesenchymal Bone Marrow Stromal Cells Secreting Neurotrophic Factors (MSC-NTF), in Patients With Amyotrophic Lateral Sclerosis (ALS). | Amyotrophic Lateral Sclerosis | Biological: MSC_NTF cells transplantation by multiple intramuscular injections at 24 separate sites, in addition to a single intrathechal injection into the CSF | Brainstorm-Cell Therapeutics | Hadassah Medical Organization | Completed | 20 Years | 75 Years | All | 14 | Phase 2 | Israel |
| 458 | NCT01825551 (ClinicalTrials.gov) | November 2012 | 13/3/2013 | The Effect of GCSF in the Treatment of ALS Patients | The Effect of Granulocyte Colony Stimulating Factor (GCSF) in the Treatment of Amyotrophic Lateral Sclerosis (ALS) Patients Referred to Tehran Imam Khomeini and Shariati Hospital Centers in 2013 | Amyotrophic Lateral Sclerosis | Drug: Granulocyte Colony Stimulating Factor;Drug: Placebo | Tehran University of Medical Sciences | NULL | Completed | 18 Years | 85 Years | Both | 40 | Phase 2/Phase 3 | Iran, Islamic Republic of |
| 459 | NCT01160263 (ClinicalTrials.gov) | October 2012 | 9/7/2010 | Study of Dopamine and Serotonin Transporters in Patients With Amyotrophic Lateral Sclerosis and Controls | Study of Dopamine and Serotonin Transporters in Patients With Amyotrophic Lateral Sclerosis and Controls. Analysis With 123I-FP-CIT (Datscan) and 123I-ADAM Brain SPECT | Amyotrophic Lateral Sclerosis | Drug: SPECT : 123 I-FP-CIT (DATSCAN) and 123I-ADAM | Assistance Publique - Hôpitaux de Paris | Association Française contre les Myopathies (AFM), Paris;ARS (Association pour la Recherche sur la Sclérose Latérale Amyotrophique);AGEPS | Completed | 39 Years | 66 Years | Both | 16 | Phase 3 | France |
| 460 | NCT01709149 (ClinicalTrials.gov) | October 2012 | 16/10/2012 | Study of Safety, Tolerability & Efficacy of CK-2017357 in Amyotrophic Lateral Sclerosis (ALS) | A Phase IIb, Multi-National, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Efficacy of CK-2017357 in Patients With Amyotrophic Lateral Sclerosis (ALS) (BENEFIT-ALS) | Amyotrophic Lateral Sclerosis | Drug: CK-2017357;Other: Placebo tablets;Drug: Riluzole | Cytokinetics | NULL | Completed | 18 Years | N/A | All | 711 | Phase 2 | United States;Canada;France;Germany;Ireland;Netherlands;Spain;United Kingdom |
| 461 | NCT01933321 (ClinicalTrials.gov) | September 2012 | 28/9/2012 | Effect of Intrathecal Administration of Hematopoietic Stem Cells in Patients With Amyotrophic Lateral Sclerosis (ALS) | Effect of Intrathecal Administration of Hematopoietic Stem Cells in Patients With Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis | Biological: Intrathecal autologous stem cell | Hospital Universitario Dr. Jose E. Gonzalez | NULL | Completed | 18 Years | N/A | Both | 14 | Phase 2/Phase 3 | Mexico |
| 462 | EUCTR2011-006119-70-DE (EUCTR) | 31/08/2012 | 20/06/2012 | Clinical Extension Study of Dexpramipexole in Amyotrophic Lateral Sclerosis (ALS) | An Open-Label, Multicenter, Extension Study to Evaluate the Long-Term Safety and Efficacy of Dexpramipexole (BIIB050) in Subjects With Amyotrophic Lateral Sclerosis - ENVISION | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 14.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Dexpramipexole Product Code: BIIB050/KNS-760704 Other descriptive name: Dexpramipexole | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 850 | United States;Canada;Belgium;Spain;Ireland;Australia;Netherlands;Germany;United Kingdom;Sweden | |||
| 463 | EUCTR2011-006119-70-NL (EUCTR) | 30/08/2012 | 14/06/2012 | Clinical Extension Study of Dexpramipexole in Amyotrophic Lateral Sclerosis (ALS) | An Open-Label, Multicenter, Extension Study to Evaluate the Long-Term Safety and Efficacy of Dexpramipexole (BIIB050) in Subjects With Amyotrophic Lateral Sclerosis - ENVISION | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 14.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Dexpramipexole Product Code: BIIB050/KNS-760704 Other descriptive name: Dexpramipexole | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 850 | United States;Canada;Belgium;Spain;Ireland;Australia;Germany;Netherlands;United Kingdom;Sweden | |||
| 464 | EUCTR2011-006119-70-BE (EUCTR) | 13/08/2012 | 14/06/2012 | Clinical Extension Study of Dexpramipexole in Amyotrophic Lateral Sclerosis (ALS) | An Open-Label, Multicenter, Extension Study to Evaluate the Long-Term Safety and Efficacy of Dexpramipexole (BIIB050) in Subjects With Amyotrophic Lateral Sclerosis - ENVISION | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 14.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Dexpramipexole Product Code: BIIB050/KNS-760704 Other descriptive name: Dexpramipexole | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 850 | Phase 3 | United States;Canada;Spain;Belgium;Ireland;Australia;Germany;Netherlands;United Kingdom;Sweden | ||
| 465 | EUCTR2011-006119-70-GB (EUCTR) | 10/08/2012 | 18/06/2012 | Clinical Extension Study of Dexpramipexole in Amyotrophic Lateral Sclerosis (ALS) | An Open-Label, Multicenter, Extension Study to Evaluate the Long-Term Safety and Efficacy of Dexpramipexole (BIIB050) in Subjects With Amyotrophic Lateral Sclerosis - ENVISION | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 14.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Dexpramipexole Product Code: BIIB050/KNS-760704 Other descriptive name: Dexpramipexole | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 850 | United States;Canada;Belgium;Spain;Ireland;Australia;Germany;Netherlands;United Kingdom;Sweden | |||
| 466 | EUCTR2011-006119-70-IE (EUCTR) | 03/08/2012 | 07/06/2012 | Clinical Extension Study of Dexpramipexole in Amyotrophic Lateral Sclerosis (ALS) | An Open-Label, Multicenter, Extension Study to Evaluate the Long-Term Safety and Efficacy of Dexpramipexole (BIIB050) in Subjects With Amyotrophic Lateral Sclerosis - ENVISION | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 14.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Dexpramipexole Product Code: BIIB050/KNS-760704 Other descriptive name: Dexpramipexole | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 850 | United States;Canada;Belgium;Spain;Ireland;Australia;Germany;Netherlands;United Kingdom;Sweden | |||
| 467 | EUCTR2011-006119-70-ES (EUCTR) | 27/07/2012 | 11/06/2012 | Clinical Extension Study of Dexpramipexole in Amyotrophic Lateral Sclerosis (ALS) | An Open-Label, Multicenter, Extension Study to Evaluate the Long-Term Safety and Efficacy of Dexpramipexole (BIIB050) in Subjects With Amyotrophic Lateral Sclerosis - ENVISION | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 14.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Dexpramipexole Product Code: BIIB050/KNS-760704 Other descriptive name: Dexpramipexole | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 850 | United States;Canada;Belgium;Spain;Ireland;Australia;Germany;Netherlands;United Kingdom;Sweden | |||
| 468 | NCT01622088 (ClinicalTrials.gov) | June 2012 | 3/5/2012 | Phase 3 Extension Study of Dexpramipexole in ALS | An Open-Label, Multicenter, Extension Study to Evaluate the Long-Term Safety and Efficacy of Dexpramipexole (BIIB050) in Subjects With Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis | Drug: Dexpramipexole | Knopp Biosciences | Biogen | Terminated | 18 Years | 80 Years | All | 616 | Phase 3 | United States;Australia;Belgium;Canada;France;Germany;Ireland;Netherlands;Spain;Sweden;United Kingdom |
| 469 | EUCTR2011-006119-70-SE (EUCTR) | 15/05/2012 | 19/04/2012 | Clinical Extension Study of Dexpramipexole in Amyotrophic Lateral Sclerosis (ALS) | An Open-Label, Multicenter, Extension Study to Evaluate the Long-Term Safety and Efficacy of Dexpramipexole (BIIB050) in Subjects With Amyotrophic Lateral Sclerosis - ENVISION | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 14.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Dexpramipexole Product Code: BIIB050/KNS-760704 Other descriptive name: Dexpramipexole | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 850 | United States;Canada;Belgium;Spain;Ireland;Australia;Germany;Netherlands;United Kingdom;Sweden | |||
| 470 | NCT01609283 (ClinicalTrials.gov) | May 2012 | 18/5/2012 | A Dose-escalation Safety Trial for Intrathecal Autologous Mesenchymal Stem Cell Therapy in Amyotrophic Lateral Sclerosis | A Dose-escalation Safety Trial for Intrathecal Autologous Mesenchymal Stem Cell Therapy in Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis | Biological: autologous mesenchymal stem cells | Mayo Clinic | NULL | Completed | 18 Years | N/A | All | 27 | Phase 1 | United States |
| 471 | EUCTR2011-000362-35-CZ (EUCTR) | 29/03/2012 | 05/04/2011 | Safety and Efficacy of Stem Cell Therapy of Motor Neuron Disease. | A Prospective, Non-randomized, Open Label Study to Assess the Safety and the Efficacy of Autologous Multipotent Mesenchymal Stem Cells in the Treatment of Amyotrophic Lateral Sclerosis. - AMSC in ALS | Amyotrophic lateral sclerosis MedDRA version: 17.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Suspension of human autologous MSC 3P in 1,5 ml Product Code: AMSC INN or Proposed INN: Human autologous mesenchymal stem cells | Bioinova, s.r.o. | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 2 | Czech Republic | ||
| 472 | NCT01536249 (ClinicalTrials.gov) | March 2012 | 16/2/2012 | Dexpramipexole and Cimetidine Drug Drug Interaction (DDI) | An Open-Label Study to Assess the Effect of Cimetidine on the Pharmacokinetics of Dexpramipexole (BIIB050) in Healthy Volunteers | Amyotrophic Lateral Sclerosis | Drug: Dexpramipexole;Drug: Cimetidine plus Dexpramipexole | Knopp Biosciences | NULL | Completed | 18 Years | 55 Years | Both | 14 | Phase 1 | United States |
| 473 | NCT01565395 (ClinicalTrials.gov) | March 2012 | 26/3/2012 | Incobotulinum Toxin A for Sialorrhea in Parkinson's Disease (PD)/Parkinsonism and Amyotrophic Lateral Sclerosis (ALS) | Randomized Double Blind Placebo Controlled Cross-Over Study of Incobotulinum Toxin A (Xeomin®) for Troublesome Sialorrhea in Parkinson's Disease (PD)/Parkinsonism and Amyotrophic Lateral Sclerosis (ALS) | Parkinson Disease;Amyotrophic Lateral Sclerosis | Drug: Incobotulinum Toxin A;Drug: placebo | Beth Israel Deaconess Medical Center | Merz Pharmaceuticals | Withdrawn | 20 Years | 80 Years | All | 0 | Phase 2 | United States |
| 474 | NCT01551940 (ClinicalTrials.gov) | February 2012 | 9/3/2012 | Toxin Treatment for Amyotrophic Lateral Sclerosis (ALS) Related Sialorrhea | Evaluation of Efficacy of Botulinum Toxin Type A in the Treatment of Sialorrhea in the Patient Affected by Amyotrophic Lateral Sclerosis (ALS) | Sialorrhea;Amyotrophic Lateral Sclerosis | Drug: Botox injection;Drug: Placebo injection | Hospices Civils de Lyon | NULL | Completed | 18 Years | N/A | Both | 18 | Phase 2 | France |
| 475 | NCT03828123 (ClinicalTrials.gov) | January 2012 | 20/7/2017 | Autologous Multipotent Mesenchymal Stromal Cells in the Treatment of Amyotrophic Lateral Sclerosis | A Prospective, Non-randomized, Open Label Study to Assess the Safety and the Efficacy of Autologous Multipotent Mesenchymal Stromal Cells in the Treatment of Amyotrophic Lateral Sclerosis | Motor Neuron Disease, Amyotrophic Lateral Sclerosis | Biological: Suspension of human autologous MSC 3P in 1.5 ml | Bioinova, s.r.o. | Department of Neurology, University Hospital Motol, Prague, Czech Republic | Completed | 18 Years | 65 Years | All | 26 | Phase 1/Phase 2 | NULL |
| 476 | NCT01511029 (ClinicalTrials.gov) | January 2012 | 9/1/2012 | Study to Evaluate the QTC Interval in Healthy Volunteers Dosed With Dexpramipexole (QTC = Electrocardiogram (ECG) Interval Measured From the Onset of the QRS Complex to the End of the T Wave Corrected for Heart Rate) | A Single-Center, Randomized, Blinded, Placebo- and Active-Controlled Crossover Study to Evaluate the Effect of Dexpramipexole (BIIB050) on the QTc Interval in Healthy Volunteers | Amyotrophic Lateral Sclerosis | Drug: Dexpramipexole;Drug: Dexpramipexole Placebo;Drug: Moxifloxacin | Knopp Biosciences | NULL | Completed | 18 Years | 60 Years | Both | 68 | Phase 1 | United States |
| 477 | NCT01232738 (ClinicalTrials.gov) | December 2011 | 22/10/2010 | Trial of Safety and Efficacy of Rasagiline in Patients With Amyotrophic Lateral Sclerosis (ALS) | A Multi-Center Controlled Screening Trial of Safety and Efficacy of Rasagiline in Subjects With Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis (ALS) | Drug: rasagiline | Yunxia Wang, MD | Western ALS Study Group | Completed | 21 Years | 80 Years | All | 36 | Phase 2 | United States;Canada |
| 478 | NCT01492686 (ClinicalTrials.gov) | December 2011 | 11/12/2011 | Phase 3 Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis | Efficacy and Safety Study of MCI-186 for Treatment of the Patients With Amyotrophic Lateral Sclerosis (ALS) 2 | Amyotrophic Lateral Sclerosis (ALS) | Drug: MCI-186;Drug: Placebo;Drug: MCI-186 in open label phase | Mitsubishi Tanabe Pharma Corporation | NULL | Completed | 20 Years | 75 Years | All | 137 | Phase 3 | Japan |
| 479 | NCT01640067 (ClinicalTrials.gov) | December 2011 | 9/7/2012 | Human Neural Stem Cell Transplantation in Amyotrophic Lateral Sclerosis (ALS) | Intra-spinal Cord Delivery of Human Neural Stem Cells in ALS Patients: Proposal for a Phase I Study/ Trapianto Intramidollare di Cellule Staminali Neurali Umane Come Terapia Putativa Per la SLA: Proposta di un Trial Clinico di Fase I | Amyotrophic Lateral Sclerosis | Biological: Human Neural Stem Cells | Azienda Ospedaliera Santa Maria, Terni, Italy | Azienda Ospedaliero Universitaria Maggiore della Carita;Università di Padova Italy | Completed | 20 Years | 75 Years | Both | 18 | Phase 1 | Italy |
| 480 | EUCTR2010-023161-21-FR (EUCTR) | 23/11/2011 | 06/09/2011 | Sclérose Latérale Amyotrophique (SLA) – toxine botulinique A (Botox®) | Evaluation de la toxine botulinique dans le traitement du trouble salivaire chez le patient atteint de sclérose latérale amyotrophique - SLA-TOX | Sclérose Latérale Amyotrophique (SLA) MedDRA version: 14.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: BOTOX 100 UNITES ALLERGAN (PR1) Other descriptive name: BOTULINUM TOXIN TYPE A | Hospices Civils de Lyon | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 2 | France | |||
| 481 | NCT01449578 (ClinicalTrials.gov) | November 2011 | 22/9/2011 | Dexpramipexole SAD/MAD Study | A Randomized, Blinded, Placebo-Controlled Ascending Dose Study of the Safety and Pharmacokinetics of Dexpramipexole in Healthy Volunteers | Amyotrophic Lateral Sclerosis | Drug: Dexpramipexole;Drug: Dexpramipexole Placebo | Knopp Biosciences | NULL | Completed | 18 Years | 55 Years | Both | 63 | Phase 1 | United States |
| 482 | NCT01486849 (ClinicalTrials.gov) | November 2011 | 23/11/2011 | Dose Titration Study to Test Safety and Effects of CK-2017357 in Patients With Amyotrophic Lateral Sclerosis (ALS) | A Phase II, Multicenter, Double-Blind, Randomized, Placebo-Controlled Dose Titration Study to Evaluate the Safety, Tolerability and Pharmacodynamic Effects of CK-2017357 in Patients With Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis | Drug: CK-2017357;Drug: Placebo;Drug: Riluzole 50 MG | Cytokinetics | NULL | Completed | 18 Years | N/A | All | 27 | Phase 2 | United States |
| 483 | JPRN-UMIN000006423 | 2011/10/01 | 01/10/2011 | The clinical trial to assess efficacy of mexiletine for amyotrophic lateral sclerosis | The clinical trial to assess efficacy of mexiletine for amyotrophic lateral sclerosis - Mexiletine on amyotrophic lateral sclerosis | amyotrophic lateral sclerosis | administration of mexiletine and riluzole administration of riluzole only | Department of Neurology, Graduate School of Medicine, Chiba University, Japan. | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 60 | Not selected | Japan |
| 484 | EUCTR2011-001329-26-IT (EUCTR) | 03/08/2011 | 17/11/2011 | Erythropoietin in Amyotrophic Lateral Sclerosis: a study to identify the best dose and the optimal route of administration and evaluate the safety | ErythroPOietin in ALS: a Study of dose-finding and Safety - EPOSS2010 | Amyotrophic Lateral Sclerosis MedDRA version: 14.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: EPREX*1SIR 40000UI/ML 1ML INN or Proposed INN: ERYTHROPOIETIN | ISTITUTO NEUROLOGICO CARLO BESTA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Italy | |||
| 485 | NCT01424163 (ClinicalTrials.gov) | August 2011 | 28/7/2011 | Dexpramipexole Japanese PK Study | A Single and Multiple Dose, Open-Label Study of the Pharmacokinetics, Safety, and Tolerability of Dexpramipexole (BIIB050) in Healthy Japanese and Caucasian Subjects | Amyotrophic Lateral Sclerosis | Drug: Single dose reduced;Drug: Single dose standard;Drug: Multiple Dose | Knopp Biosciences | Biogen | Completed | 18 Years | 60 Years | All | 57 | Phase 1 | United Kingdom |
| 486 | NCT01424176 (ClinicalTrials.gov) | July 2011 | 23/6/2011 | Dexpramipexole Renal PK Study | A Multicenter, Open-Label, Single-dose, Pharmacokinetic and Safety Study of Dexpramipexole (BIIB050) in Healthy Subjects and Subjects With Renal Impairment | Amyotrophic Lateral Sclerosis;Renal Insufficiency | Drug: Dexpramipexole (dose 1);Drug: Dexpramipexole (dose 2) | Knopp Biosciences | NULL | Completed | 18 Years | 75 Years | Both | 36 | Phase 1 | United States |
| 487 | EUCTR2010-022818-19-ES (EUCTR) | 09/06/2011 | 21/02/2011 | A randomized, double-blind, placebo-controlled, multi-center study of the safety and efficacy of Dexpramipexole in subjects with amyotrophic lateral sclerosis.Estudio multicéntrico, aleatorizado, doble ciego, controlado con placebo, de la seguridad y eficacia de Dexpramipexol en sujetos con Esclerosis Lateral Amiotrófica - EMPOWER | A randomized, double-blind, placebo-controlled, multi-center study of the safety and efficacy of Dexpramipexole in subjects with amyotrophic lateral sclerosis.Estudio multicéntrico, aleatorizado, doble ciego, controlado con placebo, de la seguridad y eficacia de Dexpramipexol en sujetos con Esclerosis Lateral Amiotrófica - EMPOWER | Amyotrophic lateral sclerosis (ALS)Esclerosis lateral amiotrófica (ELA) MedDRA version: 12.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral sclerosis | Product Name: Dexpramipexole Product Code: BIIB050 / KNS-760704 INN or Proposed INN: (6R)-4, 5, 6, 7 - tetrahydro-N6-propyl-2,6-benzothiazolidiamine dihydrochloride monohydrate Other descriptive name: Dexpramipexole | Biogen Idec Limited | NULL | Not Recruiting | Female: yes Male: yes | 804 | Phase 3 | Belgium;Spain;Ireland;Netherlands;Germany;United Kingdom;Sweden | ||
| 488 | EUCTR2010-022818-19-BE (EUCTR) | 07/06/2011 | 24/01/2011 | Clinical Study of Dexpramipexole in Amyotrophic Lateral Sclerosis (ALS) | A randomized, double-blind, placebo-controlled, multi-center study of the safety and efficacy of Dexpramipexole in subjects with amyotrophic lateral sclerosis. - EMPOWER | Amyotrophic lateral sclerosis (ALS) MedDRA version: 14.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Dexpramipexole Product Code: BIIB050 / KNS-760704 INN or Proposed INN: Dexpramipexole Dichydrochloride Other descriptive name: Dexpramipexole | Biogen Idec Limited | NULL | Not Recruiting | Female: yes Male: yes | 915 | Phase 3 | United States;Canada;Spain;Belgium;Ireland;Australia;Netherlands;Germany;United Kingdom;Sweden | ||
| 489 | NCT01051882 (ClinicalTrials.gov) | June 2011 | 17/1/2010 | Autologous Cultured Mesenchymal Bone Marrow Stromal Cells Secreting Neurotrophic Factors (MSC-NTF), in ALS Patients. | A Phase I/II, Open Label Study to Evaluate Safety, Tolerability and Therapeutic Effects of Transplantation of Autologous Cultured Mesenchymal Bone Marrow Stromal Cells Secreting Neurotrophic Factors (MSC-NTF), in ALS Patients. | Amyotrophic Lateral Sclerosis | Biological: MSC-NTF cells transplantation (IM);Biological: MSC-NTF cells transplantation (IT) | Brainstorm-Cell Therapeutics | Hadassah Medical Organization | Completed | 20 Years | 75 Years | All | 12 | Phase 1/Phase 2 | Israel |
| 490 | NCT01378676 (ClinicalTrials.gov) | June 2011 | 20/6/2011 | A Study to Evaluate the Effects of Multiple Doses of CK-2017357 in Patients With Amyotrophic Lateral Sclerosis (ALS) | A Phase II, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Effects of Multiple Doses of CK-2017357 in Patients With Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis | Drug: Placebo (Part A);Drug: CK-2017357 (Part A);Drug: Riluzole 50 MG (Part B);Drug: Placebo (Part B);Drug: CK-2017357 (Part B) | Cytokinetics | NULL | Completed | 18 Years | N/A | All | 49 | Phase 2 | United States |
| 491 | EUCTR2010-022818-19-NL (EUCTR) | 24/05/2011 | 11/05/2011 | Clinical Study of Dexpramipexole in Amyotrophic Lateral Sclerosis (ALS) | A randomized, double-blind, placebo-controlled, multi-center study of the safety and efficacy of Dexpramipexole in subjects with amyotrophic lateral sclerosis. - EMPOWER | Amyotrophic lateral sclerosis (ALS) MedDRA version: 14.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Dexpramipexole Product Code: BIIB050 / KNS-760704 INN or Proposed INN: Dexpramipexole Dichydrochloride Other descriptive name: Dexpramipexole | Biogen Idec Limited | NULL | Not Recruiting | Female: yes Male: yes | 915 | United States;Canada;Spain;Ireland;Australia;Germany;Netherlands;United Kingdom;Sweden | |||
| 492 | EUCTR2010-022818-19-DE (EUCTR) | 12/05/2011 | 21/02/2011 | Clinical Study of Dexpramipexole in Amyotrophic Lateral Sclerosis (ALS) | A randomized, double-blind, placebo-controlled, multi-center study of the safety and efficacy of Dexpramipexole in subjects with amyotrophic lateral sclerosis. - EMPOWER | Amyotrophic lateral sclerosis (ALS) MedDRA version: 14.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Dexpramipexole Product Code: BIIB050 / KNS-760704 INN or Proposed INN: Dexpramipexole Dihydrochloride Other descriptive name: Dexpramipexole | Biogen Idec Limited | NULL | Not Recruiting | Female: yes Male: yes | 915 | United States;Canada;Spain;Ireland;Australia;Netherlands;Germany;United Kingdom;Sweden | |||
| 493 | EUCTR2010-021179-10-GB (EUCTR) | 18/04/2011 | 31/01/2011 | An Open Label safety Extension study of olesoxime (TRO19622) in Amyotrophic Lateral Sclerosis (ALS) patients treated with riluzole. - OLE safety study of TRO19622 for ALS patients treated with riluzole | An Open Label safety Extension study of olesoxime (TRO19622) in Amyotrophic Lateral Sclerosis (ALS) patients treated with riluzole. - OLE safety study of TRO19622 for ALS patients treated with riluzole | Disease under investigation : Amyotrophic lateral Sclerosis MedDRA version: 14.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: olesoxime Product Code: TRO19622 INN or Proposed INN: Olesoxime Other descriptive name: 4 cholesten-3-one, oxime | TROPHOS | NULL | Not Recruiting | Female: yes Male: yes | 350 | Germany;United Kingdom;Spain | |||
| 494 | EUCTR2010-022818-19-IE (EUCTR) | 08/04/2011 | 15/02/2011 | Clinical Study of Dexpramipexole in Amyotrophic Lateral Sclerosis (ALS) | A randomized, double-blind, placebo-controlled, multi-center study of the safety and efficacy of Dexpramipexole in subjects with amyotrophic lateral sclerosis. - EMPOWER | Amyotrophic lateral sclerosis (ALS) MedDRA version: 15.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Dexpramipexole Product Code: BIIB050 / KNS-760704 INN or Proposed INN: Dexpramipexole Dichydrochloride Other descriptive name: Dexpramipexole | Biogen Idec Limited | NULL | Not Recruiting | Female: yes Male: yes | 915 | United States;Canada;Spain;Ireland;Australia;Netherlands;Germany;United Kingdom;Sweden | |||
| 495 | EUCTR2010-022818-19-SE (EUCTR) | 07/04/2011 | 09/02/2011 | Clinical Study of Dexpramipexole in Amyotrophic Lateral Sclerosis (ALS) | A randomized, double-blind, placebo-controlled, multi-center study of the safety and efficacy of Dexpramipexole in subjects with amyotrophic lateral sclerosis. - EMPOWER | Amyotrophic lateral sclerosis (ALS) MedDRA version: 14.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Dexpramipexole Product Code: BIIB050 / KNS-760704 INN or Proposed INN: Dexpramipexole Dichydrochloride Other descriptive name: Dexpramipexole | Biogen Idec Limited | NULL | Not Recruiting | Female: yes Male: yes | 915 | Spain;Ireland;Australia;Netherlands;Germany;United Kingdom;Sweden;United States;Canada | |||
| 496 | EUCTR2010-022818-19-GB (EUCTR) | 22/03/2011 | 10/01/2011 | Clinical Study of Dexpramipexole in Amyotrophic Lateral Sclerosis (ALS) | A randomized, double-blind, placebo-controlled, multi-center study of the safety and efficacy of Dexpramipexole in subjects with amyotrophic lateral sclerosis. - EMPOWER | amyotrophic lateral sclerosis (ALS) MedDRA version: 14.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Dexpramipexole Product Code: BIIB050 / KNS-760704 INN or Proposed INN: Dexpramipexole Dichydrochloride Other descriptive name: Dexpramipexole | Biogen Idec Limited | NULL | Not Recruiting | Female: yes Male: yes | 915 | United States;Canada;Spain;Ireland;Australia;Netherlands;Germany;United Kingdom;Sweden | |||
| 497 | EUCTR2010-021179-10-DE (EUCTR) | 15/03/2011 | 12/11/2010 | An Open-Label Safety Extension Study of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) patients treated with riluzole. | An Open-Label Safety Extension Study of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) patients treated with riluzole. | Amyotrophic Lateral Sclerosis. MedDRA version: 12.1;Level: LLT;Classification code 10052889;Term: ALS | Product Name: olesoxime Product Code: TRO19622 INN or Proposed INN: olesoxime Other descriptive name: 4-cholesten-3-one, oxime | TROPHOS SA | NULL | Not Recruiting | Female: yes Male: yes | Spain;Germany;United Kingdom | ||||
| 498 | NCT00876772 (ClinicalTrials.gov) | March 2011 | 6/4/2009 | Olanzapine for the Treatment of Appetite Loss in Amyotrophic Lateral Sclerosis (ALS) | Randomized, Placebo-controlled Parallel Group Study for the Evaluation of an Oral Dose of 10mg Olanzapine in Combination With Riluzole for the Treatment of Loss of Appetite in Patients With Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis (ALS) | Drug: Olanzapine | Charite University, Berlin, Germany | NULL | Recruiting | 18 Years | 80 Years | Both | 40 | Phase 2/Phase 3 | Germany |
| 499 | NCT01281189 (ClinicalTrials.gov) | March 2011 | 20/1/2011 | Phase 3 Study of Dexpramipexole in ALS | A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of the Safety and Efficacy of Dexpramipexole in Subjects With Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis | Drug: Dexpramipexole;Drug: Placebo | Knopp Biosciences | NULL | Completed | 18 Years | 80 Years | All | 943 | Phase 3 | United States;Australia;Belgium;Canada;France;Germany;Ireland;Netherlands;Spain;Sweden;United Kingdom |
| 500 | NCT01257581 (ClinicalTrials.gov) | March 2011 | 8/12/2010 | Safety and Efficacy Study of Creatine and Tamoxifen in Volunteers With Amyotrophic Lateral Sclerosis (ALS) | Phase 2 Selection Trial of High Dosage Creatine and Two Dosages of Tamoxifen in Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis | Drug: creatine;Drug: tamoxifen | Nazem Atassi | ALS Therapy Alliance;State University of New York - Upstate Medical University | Completed | 18 Years | N/A | All | 60 | Phase 2 | United States |
| 501 | NCT01363401 (ClinicalTrials.gov) | February 2011 | 30/5/2011 | Safety and Efficacy Study of Autologous Bone Marrow Derived Stem Cell Treatment in Amyotrophic Lateral Sclerosis | An Open-label, Phase I/II Trial for Safety and Efficacy Study of Autologous Bone Marrow Derived Stem Cell Treatment in Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis;ALS | Biological: HYNR-CS inj;Other: Control group | Corestem, Inc. | NULL | Completed | 25 Years | 75 Years | All | 72 | Phase 1/Phase 2 | Korea, Republic of |
| 502 | NCT02880033 (ClinicalTrials.gov) | February 2011 | 3/8/2016 | Oxidative Stress and Apoptosis of Energy Metabolism by Deferiprone From the Circulating Lymphocytes | Modulation of Oxidative Stress and Apoptosis of Energy Metabolism by Deferiprone From the Circulating Lymphocytes of Patients With Parkinson's Disease or Amyotrophic Lateral Sclerosis | Parkinson's Disease;Amyotrophic Lateral Sclerosis;Oxidative Stress;Iron Overload | Drug: deferiprone;Drug: placebo | University Hospital, Lille | NULL | Completed | 18 Years | 80 Years | All | 90 | N/A | France |
| 503 | NCT01277315 (ClinicalTrials.gov) | February 2011 | 13/1/2011 | Safety and Tolerability of Anakinra in Combination With Riluzol in Amyotrophic Lateral Sclerosis | Open Safety and Tolerability Trial to Evaluate a Subcutaneous Injection Solution of 100 mg of Anakinra in Combination With Riluzol in Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis (ALS) | Drug: Anakinra | Charite University, Berlin, Germany | Max Planck Institute for Infection Biology | Recruiting | 18 Years | 80 Years | Both | 20 | Phase 2 | Germany |
| 504 | NCT01281631 (ClinicalTrials.gov) | February 2011 | 17/1/2011 | A Study of NP001 in Subjects With Amyotrophic Lateral Sclerosis (ALS) | A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of NP001 in Subjects With Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis | Drug: NP001;Drug: Placebo | Neuraltus Pharmaceuticals, Inc. | NULL | Completed | 21 Years | 80 Years | Both | 136 | Phase 2 | United States |
| 505 | EUCTR2010-021179-10-BE (EUCTR) | 28/01/2011 | 05/01/2011 | An Open-Label Safety Extension Study of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) patients treated with riluzole. | An Open-Label Safety Extension Study of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) patients treated with riluzole. | Amyotrophic Lateral Sclerosis. MedDRA version: 12.1;Level: LLT;Classification code 10052889;Term: ALS | Product Name: olesoxime Product Code: TRO19622 INN or Proposed INN: olesoxime Other descriptive name: 4-cholesten-3-one, oxime | TROPHOS SA | NULL | Not Recruiting | Female: yes Male: yes | Phase 2;Phase 3 | Spain;Belgium;Germany;United Kingdom | |||
| 506 | EUCTR2010-022808-40-IT (EUCTR) | 13/01/2011 | 02/02/2011 | A fase II, randomized, Double-Blind, Placebo-Controlled, Multicentre Study for the Safety and Efficacy on Spasticity Symptoms of a Cannabis Sativa Extract in Motor Neuron Disease Patients - ND | A fase II, randomized, Double-Blind, Placebo-Controlled, Multicentre Study for the Safety and Efficacy on Spasticity Symptoms of a Cannabis Sativa Extract in Motor Neuron Disease Patients - ND | amyotrophic lateral sclerosis MedDRA version: 9.1;Level: PT;Classification code 10002026 | Trade Name: sativex INN or Proposed INN: sativex | FONDAZIONE CENTRO S. RAFFAELE DEL MONTE TABOR | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Italy | ||||
| 507 | NCT03085706 (ClinicalTrials.gov) | October 2010 | 15/3/2017 | Transplantation of Autologous Peripheral Blood Mononuclear Cells for Amyotrophic Lateral Sclerosis | Transplantation of Autologous Peripheral Blood Mononuclear Cells in the Subarachnoid Space for Amyotrophic Lateral Sclerosis: a Safety Analysis of 14 Patients | Amyotrophic Lateral Sclerosis | Biological: PBMC autotransplantation | The First Affiliated Hospital of Dalian Medical University | NULL | Completed | 31 Years | 75 Years | All | 14 | N/A | China |
| 508 | NCT01285583 (ClinicalTrials.gov) | October 2010 | 26/1/2011 | Safety Extension Study of TRO19622 in ALS | An Open-label Safety Extension Study of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) Patients Treated With Riluzole | Amyotrophic Lateral Sclerosis | Drug: TRO19622 | Hoffmann-La Roche | NULL | Completed | N/A | N/A | Both | 271 | Phase 2/Phase 3 | Belgium;France;Germany;Spain;United Kingdom |
| 509 | NCT01259050 (ClinicalTrials.gov) | October 2010 | 10/12/2010 | Safety Study of High Doses of Zinc in ALS Patients | Phase 1 Open Label Study of Zinc Therapy in ALS Patients | Amyotrophic Lateral Sclerosis | Drug: Zinc and Copper | Phoenix Neurological Associates, LTD | NULL | Completed | 18 Years | 85 Years | Both | 10 | Phase 1/Phase 2 | United States |
| 510 | EUCTR2010-020257-13-IT (EUCTR) | 30/07/2010 | 05/07/2010 | A pilot, prospective, randomized, open, blinded end point, phase II study of tolerability and efficacy of Eperisone in Amyotrophic Lateral Sclerosis - EPERISONE AND ALS | A pilot, prospective, randomized, open, blinded end point, phase II study of tolerability and efficacy of Eperisone in Amyotrophic Lateral Sclerosis - EPERISONE AND ALS | PATIENTS WITH AMYOTROPHIC LATERAL SCLEROSIS MedDRA version: 9.1;Level: SOC;Classification code 10029205 | Trade Name: MYONAL*30CPR RIV 100MG INN or Proposed INN: EPERISONE Trade Name: LIORESAL*50CPR 10MG INN or Proposed INN: Baclofen | AZIENDA OSPEDALIERO-UNIVERSITARIA | NULL | Not Recruiting | Female: yes Male: yes | Phase 2 | Italy | |||
| 511 | NCT01091142 (ClinicalTrials.gov) | July 2010 | 19/3/2010 | Single-Ascending-Dose Safety/Tolerability of NP001 in Amyotrophic Lateral Sclerosis (ALS) | Single-Ascending-Dose Safety and Tolerability Study of NP001 in Subjects With Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis | Drug: NP001;Drug: Placebo | Neuraltus Pharmaceuticals, Inc. | NULL | Completed | 21 Years | 75 Years | Both | 56 | Phase 1 | United States |
| 512 | EUCTR2008-003982-21-FR (EUCTR) | 10/06/2010 | 14/01/2010 | Etude des transporteurs de la dopamine et de la sérotonine en imagerie TEMP utilisant les radiopharmaceutiques 123I-FP-CIT (datscan) and 123 I-ADAM dans la sclérose latérale amyotrophique et dans une population contrôle. DOSERALS - DOSERALS | Etude des transporteurs de la dopamine et de la sérotonine en imagerie TEMP utilisant les radiopharmaceutiques 123I-FP-CIT (datscan) and 123 I-ADAM dans la sclérose latérale amyotrophique et dans une population contrôle. DOSERALS - DOSERALS | Patients présentant une SLA et volontaires sains MedDRA version: 8.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis | Trade Name: DaTSCAN Product Name: Datscan INN or Proposed INN: Ioflupane 123I Product Name: [I-123] ADAM INN or Proposed INN: [I-123] ADAM | ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP) | NULL | Not Recruiting | Female: yes Male: yes | France | ||||
| 513 | NCT01142856 (ClinicalTrials.gov) | June 2010 | 10/6/2010 | Mesenchymal Stem Cells for Treatment of Amyotrophic Lateral Sclerosis (ALS) | A Single Patient Treatment Protocol for Autologous Mesenchymal Stem Cell Intraspinal Therapy in Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis | Biological: autologous mesenchymal stem cells | Mayo Clinic | NULL | Completed | 18 Years | N/A | Both | 1 | Phase 1 | United States |
| 514 | EUCTR2009-016066-91-IT (EUCTR) | 10/03/2010 | 17/11/2009 | SAFETY AND EFFICACY OF ERYTHROPOIETIN IN AMYOTROPHIC LATERAL SCLEROSIS: A RANDOMIZED, PLACEBO-CONTROLLED CLINICAL TRIAL - ND | SAFETY AND EFFICACY OF ERYTHROPOIETIN IN AMYOTROPHIC LATERAL SCLEROSIS: A RANDOMIZED, PLACEBO-CONTROLLED CLINICAL TRIAL - ND | ALS MedDRA version: 9.1;Level: SOC;Classification code 10029205 | Trade Name: EPREX*1SIR 40000UI/ML 1ML INN or Proposed INN: Erythropoietin | ISTITUTO NEUROLOGICO CARLO BESTA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Italy | ||||
| 515 | NCT01082653 (ClinicalTrials.gov) | March 2010 | 1/3/2010 | Safety/Efficacy Study for the Treatment of Amyotrophic Lateral Sclerosis | Phase I, Single Center, Prospective, Non-randomized, Open Label, Safety/Efficacy Study of the Infusion of Autologous Bone Marrow-derived Stem Cells, in Patients With Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis | Biological: autologous bone marrow-derived stem cells | TCA Cellular Therapy | NULL | Suspended | 18 Years | 80 Years | Both | 6 | Phase 1 | United States |
| 516 | NCT01089010 (ClinicalTrials.gov) | March 2010 | 16/3/2010 | A Study of CK-2017357 in Patients With Amyotrophic Lateral Sclerosis (ALS) | A Phase II, Double-Blind, Randomized, Placebo-Controlled, Three-Way Crossover, Pharmacokinetic and Pharmacodynamic Study of CK-2017357 in Patients With Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis | Drug: Placebo;Drug: 250 mg CK-2017357;Drug: 500 mg CK-2017357 | Cytokinetics | NULL | Completed | 18 Years | N/A | All | 67 | Phase 2 | United States |
| 517 | NCT01041222 (ClinicalTrials.gov) | January 2010 | 30/12/2009 | Safety, Tolerability, and Activity Study of ISIS SOD1Rx to Treat Familial Amyotrophic Lateral Sclerosis (ALS) Caused by SOD1 Gene Mutations | A Phase 1, Double-Blind, Placebo-Controlled, Dose-Escalation Study of the Safety, Tolerability, and Pharmacokinetics of ISIS 333611 Administered Intrathecally to Patients With Familial Amyotrophic Lateral Sclerosis Due to Superoxide Dismutase 1 Gene Mutations | Familial Amyotrophic Lateral Sclerosis | Drug: ISIS 333611 | Isis Pharmaceuticals | Muscular Dystrophy Association;ALS Association | Completed | 18 Years | N/A | Both | 33 | Phase 1 | United States |
| 518 | NCT01083667 (ClinicalTrials.gov) | November 2009 | 17/12/2009 | SOD1 Inhibition by Pyrimethamine in Familial Amyotrophic Lateral Sclerosis (ALS) | Phase I/II Study of SOD1 Inhibition by Pyrimethamine in Familial ALS | Familial Amyotrophic Lateral Sclerosis | Drug: Pyrimethamine | Weill Medical College of Cornell University | Muscular Dystrophy Association | Completed | 18 Years | N/A | All | 32 | Phase 1/Phase 2 | United States;Germany;Italy;Sweden |
| 519 | NCT01016522 (ClinicalTrials.gov) | November 2009 | 18/11/2009 | Safety and Tolerability of the Ketogenic Diet in Amyotrophic Lateral Sclerosis (ALS) | Safety and Tolerability of the Ketogenic Diet in ALS | Amyotrophic Lateral Sclerosis | Dietary Supplement: KetoCal | Johns Hopkins University | Nutricia North America;Cornell University | Terminated | 18 Years | N/A | Both | 1 | Phase 3 | United States |
| 520 | NCT00983983 (ClinicalTrials.gov) | October 2009 | 23/9/2009 | High Fat/High Calorie Trial in Amyotrophic Lateral Sclerosis | Phase II Safety and Tolerability Study of High Fat/High Calorie Versus High Calorie Versus Optimal Nutrition in Subjects With Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis | Dietary Supplement: Oxepa;Dietary Supplement: Jevity 1.5;Dietary Supplement: Jevity 1.0 | Massachusetts General Hospital | Muscular Dystrophy Association | Completed | 18 Years | N/A | All | 28 | Phase 2 | United States |
| 521 | NCT00982150 (ClinicalTrials.gov) | September 2009 | 22/9/2009 | Extension Study of Talampanel for Amyotrophic Lateral Sclerosis (ALS) | A Multinational, Multicenter, Open Label Phase to Assess Tolerability and Safety of Talampanel 50mg Tid in Subjects With Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis | Drug: Talampanel | Teva Pharmaceutical Industries | NULL | Terminated | 18 Years | 80 Years | Both | 446 | Phase 2 | United States;Belgium;Canada;France;Germany;Hungary;Israel;Italy;Netherlands;Spain |
| 522 | EUCTR2008-007320-25-ES (EUCTR) | 10/08/2009 | 16/07/2009 | Phase II/III, multicenter, randomized, parallel group,double-blind, placebo controlled study to assess safety and efficacy of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) patients treated with riluzoleEstudio fase II/III, multicéntrico, aleatorizado, de grupos paralelos, doble ciego, controlado con placebo, para valorar la seguridad y eficacia de TRO 19622 en pacientes con Esclerosis Lateral Amiotrófica (ELA) tratados con riluzol. | Phase II/III, multicenter, randomized, parallel group,double-blind, placebo controlled study to assess safety and efficacy of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) patients treated with riluzoleEstudio fase II/III, multicéntrico, aleatorizado, de grupos paralelos, doble ciego, controlado con placebo, para valorar la seguridad y eficacia de TRO 19622 en pacientes con Esclerosis Lateral Amiotrófica (ELA) tratados con riluzol. | ESCLEROSIS LATERAL AMIOTRÓFICA.ALS is a fatal neuromuscular disorder causing progressive loss of nervous control of voluntary muscles due to destruction of motor neurons in the brain and spinal cord.Riluzole is the only approved drug that has been shown to prolong survival of ALS patients but its efficacy is limited.Consequently, there is a strong medical need to identify other compounds and to evaluate in clinical studies their potential to become a treatment of this devastating disease. MedDRA version: 9.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral sclerosis | Product Name: TRO19622 Product Code: TRO19622 INN or Proposed INN: olesoxime Other descriptive name: 4-cholesten-3-one, oxime | TROPHOS SA | NULL | Not Recruiting | Female: yes Male: yes | 470 | Phase 2 | France;Belgium;Spain;Germany;United Kingdom | ||
| 523 | JPRN-UMIN000002276 | 2009/08/01 | 01/08/2009 | Developmental research of communication devices based on the brain machine interface using electroencephalograms | Developmental research of communication devices based on the brain machine interface using electroencephalograms - Communication devices using EEG-based BMI | amyotrophic lateral sclerosis | Let the patients use the communication devices to select characters on a computer monitor as they intend by recording EEG. | Osaka University | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 10 | Not applicable | Japan |
| 524 | EUCTR2008-007320-25-GB (EUCTR) | 24/07/2009 | 14/04/2009 | Phase II/III, multicenter, randomized, parallel group, double-blind, placebo controlled study to assess safety and efficacy of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) patients treated with riluzole. - Safety and efficacy of TRO19622 in ALS Patients treated with riluzole. | Phase II/III, multicenter, randomized, parallel group, double-blind, placebo controlled study to assess safety and efficacy of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) patients treated with riluzole. - Safety and efficacy of TRO19622 in ALS Patients treated with riluzole. | Disease under investigation : Amyotrophic lateral Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral Sclerosis | Product Code: TRO19622 INN or Proposed INN: olesoxime Other descriptive name: 4-cholesten-3-one, oxime | TROPHOS | NULL | Not Recruiting | Female: yes Male: yes | 470 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Spain;Belgium;Germany;United Kingdom | ||
| 525 | NCT00965497 (ClinicalTrials.gov) | July 2009 | 7/8/2009 | Escitalopram (Lexapro) for Depression MS or ALS | An Open-label, 8- Week, Flexible Dose Trial of Escitalopram (Lexapro®) in Comorbid Major Depression With Amyotrophic Lateral Sclerosis and Multiple Sclerosis | Major Depression;Multiple Sclerosis;Amyotrophic Lateral Sclerosis | Drug: escitalopram | University of South Carolina | NULL | Completed | 18 Years | 70 Years | All | 13 | Phase 3 | United States |
| 526 | NCT00931944 (ClinicalTrials.gov) | July 2009 | 30/6/2009 | Open-Label, Safety and Tolerability Extension Study of KNS-760704 in Amyotrophic Lateral Sclerosis (ALS) (CL211) | An Open-Label, Safety and Tolerability, Study Evaluating KNS-760704 in Patients With Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis | Drug: KNS-760704 | Knopp Biosciences | NULL | Completed | 21 Years | 80 Years | All | 74 | Phase 2 | United States |
| 527 | EUCTR2008-007320-25-DE (EUCTR) | 24/06/2009 | 18/02/2009 | Phase II/III, multicenter, randomized, parallel group,double-blind, placebo controlled study to assess safety and efficacy of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) patients treated with riluzole | Phase II/III, multicenter, randomized, parallel group,double-blind, placebo controlled study to assess safety and efficacy of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) patients treated with riluzole | ALS is a fatal neuromuscular disorder causing progressive loss of nervous control of voluntary muscles because of destruction of motor neurons in the brain and spinal cord.Riluzole is the only approved drug therapy that has been shown to prolong survival of ALS patients but its efficacy is limited.Consequently, there is a strong medical need to identify other compounds and to evaluate in clinical studies their potential to become a treatment of this devastating disease. MedDRA version: 9.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral sclerosis | Product Code: TRO19622 INN or Proposed INN: olesoxime Other descriptive name: 4-cholesten-3-one, oxime | TROPHOS SA | NULL | Not Recruiting | Female: yes Male: yes | 470 | Phase 2/3 | United Kingdom;Germany;Belgium;France;Spain | ||
| 528 | EUCTR2008-006722-34-IT (EUCTR) | 23/06/2009 | 11/12/2008 | Multicentric randomized placebo controlled trial of Lithium carbonate combined with Riluzole in patients with ALS - RCT ALS Lithium | Multicentric randomized placebo controlled trial of Lithium carbonate combined with Riluzole in patients with ALS - RCT ALS Lithium | Amyotrophic Lateral Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral sclerosis | Trade Name: CARBOLITHIUM INN or Proposed INN: Lithium | ISTITUTO SUPERIORE DI SANITA` | NULL | Not Recruiting | Female: yes Male: yes | Italy | ||||
| 529 | EUCTR2008-006224-61-ES (EUCTR) | 12/06/2009 | 04/05/2009 | Ensayo clínico multicéntrico, aleatorizado, controlado para evaluar la eficacia del tratamiento con carbonato de litio en pacientes con Esclerosis Lateral Amiotrófica | Ensayo clínico multicéntrico, aleatorizado, controlado para evaluar la eficacia del tratamiento con carbonato de litio en pacientes con Esclerosis Lateral Amiotrófica | Esclerosis Lateral Amiotrófica MedDRA version: 9;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis | Trade Name: PLENUR INN or Proposed INN: LITIO CARBONATO Other descriptive name: LITHIUM CARBONATE | Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau | NULL | Not Recruiting | Female: yes Male: yes | Spain | ||||
| 530 | EUCTR2008-007320-25-BE (EUCTR) | 08/06/2009 | 28/04/2009 | Phase II/III, multicenter, randomized, parallel group,double-blind, placebo controlled study to assess safety and efficacy of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) patients treated with riluzole | Phase II/III, multicenter, randomized, parallel group,double-blind, placebo controlled study to assess safety and efficacy of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) patients treated with riluzole | ALS is a fatal neuromuscular disorder causing progressive loss of nervous control of voluntary muscles because of destruction of motor neurons in the brain and spinal cord.Riluzole is the only approved drug therapy that has been shown to prolong survival of ALS patients but its efficacy is limited.Consequently, there is a strong medical need to identify other compounds and to evaluate in clinical studies their potential to become a treatment of this devastating disease. MedDRA version: 9.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral sclerosis | Product Code: TRO19622 INN or Proposed INN: olesoxime Other descriptive name: 4-cholesten-3-one, oxime | TROPHOS SA | NULL | Not Recruiting | Female: yes Male: yes | 470 | Phase 2;Phase 3 | France;Spain;Belgium;Germany;United Kingdom | ||
| 531 | NCT01384162 (ClinicalTrials.gov) | June 2009 | 23/6/2011 | An Open Label, Safety and Tolerability Continuation Study of Intracerebroventricular Administration of sNN0029 to Patients With Amyotrophic Lateral Sclerosis | An Open Label, Safety and Tolerability Continuation Study of Intracerebroventricular Administration of sNN0029 to Patients With Amyotrophic Lateral Sclerosis, Using an Implanted Catheter and SynchroMed® II Pump | Amyotrophic Lateral Sclerosis | Drug: sNN0029 | Newron Sweden AB | Medtronic;ICON Clinical Research | Terminated | 18 Years | 75 Years | Both | 15 | Phase 1/Phase 2 | Belgium |
| 532 | NCT00925847 (ClinicalTrials.gov) | June 2009 | 19/6/2009 | Effect of Lithium Carbonate in Patients With Amyotrophic Lateral Sclerosis | Open Multicenter Study of Lithium in Patients With Amyotrophic Lateral Sclerosis LISLA | Amyotrophic Lateral Sclerosis | Drug: lithium | Assistance Publique - Hôpitaux de Paris | NULL | Completed | 18 Years | N/A | Both | 23 | Phase 2 | France |
| 533 | EUCTR2008-005106-38-ES (EUCTR) | 14/05/2009 | 26/02/2009 | ENSAYO CLÍNICO RANDOMIZADO DOBLE CIEGO DE CARBONATO DE LITIO COMO TERAPIA DE ASOCIACIÓN EN ESCLEROSIS LATERAL AMIOTRÓFICA (FASE II) - LIELA | ENSAYO CLÍNICO RANDOMIZADO DOBLE CIEGO DE CARBONATO DE LITIO COMO TERAPIA DE ASOCIACIÓN EN ESCLEROSIS LATERAL AMIOTRÓFICA (FASE II) - LIELA | Esclerosis Lateral Amiotrofica MedDRA version: 9.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral sclerosis | Trade Name: PLENUR INN or Proposed INN: LITIO CARBONATO Other descriptive name: LITHIUM CARBONATE | Lucia Galan Hospital Clinico San Carlos | NULL | Not Recruiting | Female: yes Male: yes | 280 | Spain | |||
| 534 | NCT00875446 (ClinicalTrials.gov) | May 13, 2009 | 2/4/2009 | First Time in Human Study of GSK1223249 in Amyotrophic Lateral Sclerosis | A Single and Repeat Dose Escalation Study of the Safety, Pharmacokinetics and Pharmacodynamics of GSK1223249 in ALS Patients | Amyotrophic Lateral Sclerosis | Drug: PLACEBO;Drug: GSK1223249 | GlaxoSmithKline | NULL | Completed | 18 Years | 80 Years | All | 76 | Phase 1 | United States;France;Italy;United Kingdom |
| 535 | NCT00868166 (ClinicalTrials.gov) | April 30, 2009 | 23/3/2009 | Safety and Efficacy of TRO19622 as add-on Therapy to Riluzole Versus Placebo in Treatment of Patients Suffering From ALS | Phase II/III, Multicenter, Randomized, Parallel Group, Double-blind, Placebo Controlled Study to Assess Safety and Efficacy of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) Patients Treated With Riluzole | Amyotrophic Lateral Sclerosis | Drug: Olesoxime;Drug: Placebo Comparator;Drug: Riluzole | Hoffmann-La Roche | European Commission | Completed | 18 Years | 80 Years | All | 512 | Phase 3 | Belgium;France;Germany;Spain;United Kingdom;Netherlands |
| 536 | NCT00886977 (ClinicalTrials.gov) | April 2009 | 21/4/2009 | Efficacy and Safety of YAM80 in Amyotrophic Lateral Sclerosis (ALS) | Pilot-Study of YAM80 in Amyotrophic Lateral Sclerosis. Evaluation of the Efficacy and Safety of YAM80 in Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis | Drug: YAM80 | Yoshino Neurology Clinic | NULL | Active, not recruiting | 25 Years | 65 Years | Both | 25 | Phase 2 | Japan |
| 537 | EUCTR2009-010060-41-IT (EUCTR) | 24/02/2009 | 06/03/2009 | Evaluation of efficacy of lithium salts therapy in patients with Amyotrophic Lateral Sclerosis. - ND | Evaluation of efficacy of lithium salts therapy in patients with Amyotrophic Lateral Sclerosis. - ND | Amyotrophic Lateral Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral sclerosis | Trade Name: LITIO CARBONATO INN or Proposed INN: Lithium Trade Name: RILUTEK INN or Proposed INN: Riluzole | AZIENDA OSPEDALIERA PISANA | NULL | Not Recruiting | Female: yes Male: yes | Italy | ||||
| 538 | EUCTR2008-006891-31-GB (EUCTR) | 17/02/2009 | 28/07/2010 | A randomised placebo-controlled trial of Lithium carbonate in Amyotrophic Lateral Sclerosis (LiCALS) - LiCALS | A randomised placebo-controlled trial of Lithium carbonate in Amyotrophic Lateral Sclerosis (LiCALS) - LiCALS | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 9.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral sclerosis | Trade Name: Lithium Apogepha Product Name: Lithium Carbonate Other descriptive name: LITHIUM CARBONATE Trade Name: Lithium Carbonate Product Name: Lithium Carbonate Other descriptive name: LITHIUM CARBONATE Trade Name: Lithium Citrate Product Name: Lithium Citrate Other descriptive name: LITHIUM CITRATE | King's College London | NULL | Not Recruiting | Female: yes Male: yes | 220 | Phase 4 | United Kingdom | ||
| 539 | EUCTR2008-007320-25-FR (EUCTR) | 17/02/2009 | 16/03/2009 | Phase II/III, multicenter, randomized, parallel group,double-blind, placebo controlled study to assess safety and efficacy of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) patients treated with riluzole | Phase II/III, multicenter, randomized, parallel group,double-blind, placebo controlled study to assess safety and efficacy of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) patients treated with riluzole | ALS is a fatal neuromuscular disorder causing progressive loss of nervous control of voluntary muscles because of destruction of motor neurons in the brain and spinal cord.Riluzole is the only approved drug therapy that has been shown to prolong survival of ALS patients but its efficacy is limited.Consequently, there is a strong medical need to identify other compounds and to evaluate in clinical studies their potential to become a treatment of this devastating disease. MedDRA version: 9.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral sclerosis | Product Code: TRO19622 INN or Proposed INN: olesoxime Other descriptive name: 4-cholesten-3-one, oxime | TROPHOS SA | NULL | Not Recruiting | Female: yes Male: yes | 470 | Phase 2;Phase 3 | France;Spain;Belgium;Germany;United Kingdom | ||
| 540 | JPRN-UMIN000008527 | 2009/01/01 | 25/07/2012 | Study of efficacy and safety of NDDPX08 in ALS patients | Study of efficacy and safety of NDDPX08 in ALS patients - NDDPX08-ALS clinical research | Amyotrophic Lateral Sclerosis | For patients who begin to receive Rilutek treatment at the start or 4 weeks before the start of the observation period, the 12-week treatment with Rilutek alone (100 mg/day) during the observation period is followed by combined treatment (Rilutek + NDDPX08). The NDDPX08 dose level begins at 1.25 mg/day and is increased in steps to 15 mg/day during the 12-week treatment period according to the dose escalation schedule given on the next page (Fig. 1). If any serious adverse reaction arises following a dose increase to 10 mg/day and it is judged to be difficult to maintain this dose level, the dose level of 7.5 mg/day is regarded as the maintenance dose level. If alleviation of symptoms is noted during dose escalation steps, the dose level producing alleviation of symptoms is used as the maintenance dose level. The total NDDPX08 treatment period is 58-90 weeks (including the 4 weeks during which the dose level is reduced in steps). Follow-up of adverse events is continued until 1 month after the end of NDDPX08 treatment. Placebo (lactose) is administered to 10 of the 50 subjects planned to be enrolled in the study. | FeGALS | NULL | Complete: follow-up complete | 20years-old | 75years-old | Male and Female | 50 | Not selected | Japan |
| 541 | NCT00706147 (ClinicalTrials.gov) | January 2009 | 24/6/2008 | Phase II/III Randomized, Placebo-controlled Trial of Arimoclomol in SOD1 Positive Familial Amyotrophic Lateral Sclerosis | Phase II/III Randomized, Placebo-Controlled Trial of Arimoclomol in SOD1 Positive Familial Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis | Drug: Arimoclomol;Drug: Placebo | University of Miami | Massachusetts General Hospital | Completed | 18 Years | N/A | All | 38 | Phase 2/Phase 3 | United States |
| 542 | NCT00818389 (ClinicalTrials.gov) | January 2009 | 6/1/2009 | Study to Investigate the Safety and Efficacy of Lithium in Volunteers With Amyotrophic Lateral Sclerosis (ALS) | A Multicenter, Double-Blind, Placebo-Controlled, Study to Investigate the Safety and Efficacy of Lithium in Combination With Riluzole in Volunteers With Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis | Drug: Lithium Carbonate;Drug: Riluzole;Drug: placebo | Massachusetts General Hospital | ALS Association;ALS Society of Canada;National Institute of Neurological Disorders and Stroke (NINDS);University of Toronto;State University of New York - Upstate Medical University;Columbia University;University of Kentucky | Terminated | 18 Years | N/A | All | 84 | Phase 2/Phase 3 | United States;Canada |
| 543 | NCT02242071 (ClinicalTrials.gov) | December 2008 | 12/9/2014 | Cell Therapy for Motor Neuron Disease/Amyotrophic Lateral Sclerosis | The Effect of Autologous Bone Marrow Mononuclear Cell Transplantation on Motor Neuron Disease/Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis | Biological: Stem Cell | Neurogen Brain and Spine Institute | NULL | Withdrawn | 18 Years | 80 Years | All | 0 | Phase 1 | India |
| 544 | NCT00800501 (ClinicalTrials.gov) | December 2008 | 29/11/2008 | A Safety and Tolerability Study of Intracerebroventricular Administration of sNN0029 to Patients With Amyotrophic Lateral Sclerosis | A Double-blind, Randomised, Parallel Group Safety and Tolerability Study of Intracerebroventricular Administration of sNN0029 to Patients With Amyotrophic Lateral Sclerosis, Using an Implanted Catheter and SynchroMed® II Pump | Amyotrophic Lateral Sclerosis | Drug: sNN0029;Drug: Placebo | Newron Sweden AB | Medtronic;ICON Clinical Research | Completed | 18 Years | 75 Years | Both | 18 | Phase 1/Phase 2 | Belgium |
| 545 | NCT01984814 (ClinicalTrials.gov) | December 2008 | 8/11/2013 | Stem Cell Therapy for Amyotrophic Lateral Sclerosis | The Effect of Autologous Bone Marrow Mononuclear Cell Transplantation on the Survival Duration in Amyotrophic Lateral Sclerosis - A Retrospective Control Study | Amyotrophic Lateral Sclerosis | Biological: Stem cell | Neurogen Brain and Spine Institute | NULL | Withdrawn | 26 Years | 76 Years | All | 0 | Phase 2 | India |
| 546 | EUCTR2007-003775-39-DE (EUCTR) | 29/10/2008 | 09/09/2008 | Randomised, placebo-controlled parallel-group trial to evaluate an oral dose of 10 mg Olanzapin combined with Riluzol for the treatment of appetite loss on patients with amyotrophic lateral sklerosis - Olanzapin in treatment of ALS-related appetite loss | Randomised, placebo-controlled parallel-group trial to evaluate an oral dose of 10 mg Olanzapin combined with Riluzol for the treatment of appetite loss on patients with amyotrophic lateral sklerosis - Olanzapin in treatment of ALS-related appetite loss | patients with amyotrophic lateral sclerosis | Trade Name: Zyprexa INN or Proposed INN: OLANZAPINE | Charité – Universitätsmedizin Berlin | NULL | Not Recruiting | Female: yes Male: yes | Germany | ||||
| 547 | EUCTR2008-002062-62-NL (EUCTR) | 14/10/2008 | 02/06/2008 | A Multinational, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Tolerability and Safety of talampanel in Subjects with Amyotrophic Lateral Sclerosis (ALS) | A Multinational, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Tolerability and Safety of talampanel in Subjects with Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic lateral sclerosis (ALS). MedDRA version: 9.1;Level: PT;Classification code 10052653;Term: Amyotrophic lateral sclerosis gene carrier | Product Name: talampanel Product Code: TV-7110 INN or Proposed INN: Not available yet Other descriptive name: talampanel Product Name: talampanel Product Code: TV-7110 INN or Proposed INN: Not available yet Other descriptive name: talampanel | Teva Pharmaceutical Industries, Ltd | NULL | Not Recruiting | Female: yes Male: yes | 540 | Hungary;Germany;Netherlands;Belgium;France;Spain;Italy | |||
| 548 | EUCTR2008-003707-32-FR (EUCTR) | 09/10/2008 | 22/08/2008 | Etude de l'effet du carbonate de lithium sur une population de patients atteints de SLA en ouvert en comparaison avec une population de référence. LISLA - LISLA | Etude de l'effet du carbonate de lithium sur une population de patients atteints de SLA en ouvert en comparaison avec une population de référence. LISLA - LISLA | Patient atteint de sclérose latérale amyotrophique. MedDRA version: 8.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis | Trade Name: Téralithe LP Product Name: Téralithe LP INN or Proposed INN: Carbonate de lithium | ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | France | ||||
| 549 | EUCTR2008-002062-62-FR (EUCTR) | 22/09/2008 | 19/06/2008 | A Multinational, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Tolerability and Safety of talampanel in Subjects with Amyotrophic Lateral Sclerosis (ALS) | A Multinational, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Tolerability and Safety of talampanel in Subjects with Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic lateral sclerosis (ALS). MedDRA version: 9.1;Level: PT;Classification code 10052653;Term: Amyotrophic lateral sclerosis gene carrier | Product Name: talampanel Product Code: TV-7110 INN or Proposed INN: Not available yet Other descriptive name: talampanel Product Name: talampanel Product Code: TV-7110 INN or Proposed INN: Not available yet Other descriptive name: talampanel | Teva Pharmaceutical Industries, Ltd | NULL | Not Recruiting | Female: yes Male: yes | 540 | Phase 2 | France;Hungary;Belgium;Spain;Germany;Netherlands;Italy | ||
| 550 | EUCTR2008-002062-62-HU (EUCTR) | 17/09/2008 | 17/12/2008 | A Multinational, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Tolerability and Safety of talampanel in Subjects with Amyotrophic Lateral Sclerosis (ALS).ALS-TAL-201-OL is added as an open label extension of the ALS-TAL-201 trial: A Multinational, Multicenter, Open label phase to Assess Tolerability and Safety of Talampanel 50mg tid in Subjects with Amyotrophic Lateral Sclerosis (ALS). | A Multinational, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Tolerability and Safety of talampanel in Subjects with Amyotrophic Lateral Sclerosis (ALS).ALS-TAL-201-OL is added as an open label extension of the ALS-TAL-201 trial: A Multinational, Multicenter, Open label phase to Assess Tolerability and Safety of Talampanel 50mg tid in Subjects with Amyotrophic Lateral Sclerosis (ALS). | Amyotrophic lateral sclerosis (ALS). MedDRA version: 9.1;Level: PT;Classification code 10052653;Term: Amyotrophic lateral sclerosis gene carrier | Product Name: talampanel Product Code: TV-7110 INN or Proposed INN: Not available yet Other descriptive name: talampanel Product Name: talampanel Product Code: TV-7110 INN or Proposed INN: Not available yet Other descriptive name: talampanel | Teva Pharmaceutical Industries, Ltd | NULL | Not Recruiting | Female: yes Male: yes | 540 | Hungary;Germany;Netherlands;Belgium;France;Spain;Italy | |||
| 551 | EUCTR2008-002110-22-NL (EUCTR) | 16/09/2008 | 05/08/2008 | A randomised sequential trial of Lithium in amyotrophic lateral sclerosis - Lithium in ALS | A randomised sequential trial of Lithium in amyotrophic lateral sclerosis - Lithium in ALS | Amyotrophic lateral sclerosis (ALS) is a disease characterised by progressive degeneration of motor neurons in brain and spinal cord leading to muscle weakness. ALS can occur at anytime in adulthood. Muscle weakness gradually progresses. Approximately 50% of patients die within 3 years after onset of symptoms, usually as the result of respiratory failure. To date, only one drug, i.e. riluzole, has proven to extend survival in patients with ALS, but only by approximately 3 to 6 months. MedDRA version: 9.1;Level: LLT;Classification code 10052889;Term: ALS | Trade Name: Lithiumcarbonaat 400 PCH tabletten Product Name: Lithiumcarbonaat Other descriptive name: LITHIUM CARBONATE | Prof. dr L.H. van den Berg, UMC-Utrecht | NULL | Not Recruiting | Female: yes Male: yes | Netherlands | ||||
| 552 | EUCTR2008-002062-62-DE (EUCTR) | 08/09/2008 | 19/01/2009 | A Multinational, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Tolerability and Safety of talampanel in Subjects with Amyotrophic Lateral Sclerosis (ALS).ALS-TAL-201-OL is added as an open label extension of the ALS-TAL-201 trial: A Multinational, Multicenter, Open label phase to Assess Tolerability and Safety of Talampanel 50mg tid in Subjects with Amyotrophic Lateral Sclerosis (ALS). - ALSTAR | A Multinational, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Tolerability and Safety of talampanel in Subjects with Amyotrophic Lateral Sclerosis (ALS).ALS-TAL-201-OL is added as an open label extension of the ALS-TAL-201 trial: A Multinational, Multicenter, Open label phase to Assess Tolerability and Safety of Talampanel 50mg tid in Subjects with Amyotrophic Lateral Sclerosis (ALS). - ALSTAR | Amyotrophic lateral sclerosis (ALS). MedDRA version: 9.1;Level: PT;Classification code 10052653;Term: Amyotrophic lateral sclerosis gene carrier | Product Name: talampanel Product Code: TV-7110 INN or Proposed INN: Not available yet Other descriptive name: talampanel Product Name: talampanel Product Code: TV-7110 INN or Proposed INN: Not available yet Other descriptive name: talampanel | Teva Pharmaceutical Industries, Ltd | NULL | Not Recruiting | Female: yes Male: yes | 540 | Hungary;Germany;Netherlands;Belgium;France;Spain;Italy | |||
| 553 | NCT00748501 (ClinicalTrials.gov) | September 2008 | 4/9/2008 | Clinical Trial of SB-509 in Subjects With Amyotrophic Lateral Sclerosis (ALS) | A Phase 2 Repeat-Dosing Clinical Trial of SB-509 in Subjects With Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis | Drug: SB-509 | Sangamo Biosciences | NULL | Completed | 18 Years | 85 Years | Both | 45 | Phase 2 | United States |
| 554 | NCT00696332 (ClinicalTrials.gov) | September 2008 | 10/6/2008 | Talampanel for Amyotrophic Lateral Sclerosis (ALS) | A Multinational, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Tolerability and Safety of Talampanel in Subjects With Amyotrophic Lateral Sclerosis (ALS) | ALS | Drug: Talampanel;Other: placebo | Teva Pharmaceutical Industries | NULL | Completed | 18 Years | 80 Years | Both | 559 | Phase 2 | United States;Belgium;Canada;France;Germany;Hungary;Israel;Italy;Netherlands;Spain |
| 555 | EUCTR2008-002062-62-ES (EUCTR) | 13/08/2008 | 26/06/2008 | Estudio multinacional, multicéntrico, randomizado, doble ciego, controlado con placebo y de grupos paralelos para evaluar la eficacia, tolerabilidad y seguridad de Talampanel en pacientes con Esclerosis Lateral Amiotrófica (ELA)A Multinational, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Tolerability and Safety of talampanel in Subjects with Amyotrophic Lateral Sclerosis (ALS) | Estudio multinacional, multicéntrico, randomizado, doble ciego, controlado con placebo y de grupos paralelos para evaluar la eficacia, tolerabilidad y seguridad de Talampanel en pacientes con Esclerosis Lateral Amiotrófica (ELA)A Multinational, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Tolerability and Safety of talampanel in Subjects with Amyotrophic Lateral Sclerosis (ALS) | Esclerosis Lateral Amiotrófica (ELA).Amyotrophic lateral sclerosis (ALS). MedDRA version: 9.1;Level: PT;Classification code 10052653;Term: Amyotrophic lateral sclerosis gene carrier | Product Name: talampanel Product Code: TV-7110 INN or Proposed INN: Not available yet Other descriptive name: talampanel Product Name: talampanel Product Code: TV-7110 INN or Proposed INN: Not available yet Other descriptive name: talampanel | Teva Pharmaceutical Industries, Ltd | NULL | Not Recruiting | Female: yes Male: yes | 540 | Phase 2 | France;Hungary;Belgium;Spain;Germany;Netherlands;Italy | ||
| 556 | EUCTR2008-002062-62-BE (EUCTR) | 31/07/2008 | 11/07/2008 | A Multinational, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Tolerability and Safety of talampanel in Subjects with Amyotrophic Lateral Sclerosis (ALS).ALS-TAL-201-OL is added as an open label extension of the ALS-TAL-201 trial: A Multinational, Multicenter, Open label phase to Assess Tolerability and Safety of Talampanel 50mg tid in Subjects with Amyotrophic Lateral Sclerosis (ALS). | A Multinational, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Tolerability and Safety of talampanel in Subjects with Amyotrophic Lateral Sclerosis (ALS).ALS-TAL-201-OL is added as an open label extension of the ALS-TAL-201 trial: A Multinational, Multicenter, Open label phase to Assess Tolerability and Safety of Talampanel 50mg tid in Subjects with Amyotrophic Lateral Sclerosis (ALS). | Amyotrophic lateral sclerosis (ALS). MedDRA version: 9.1;Level: PT;Classification code 10052653;Term: Amyotrophic lateral sclerosis gene carrier | Product Name: talampanel Product Code: TV-7110 INN or Proposed INN: Not available yet Other descriptive name: talampanel Product Name: talampanel Product Code: TV-7110 INN or Proposed INN: Not available yet Other descriptive name: talampanel | Teva Pharmaceutical Industries, Ltd | NULL | Not Recruiting | Female: yes Male: yes | 540 | Hungary;Germany;Netherlands;Belgium;France;Spain;Italy | |||
| 557 | EUCTR2008-002062-62-IT (EUCTR) | 16/06/2008 | 27/06/2008 | A Multinational, Multicenter, Randomized, Double-Blind, Placebo- Controlled, Parallel-Group Study to Assess the Efficacy, Tolerability and Safety of talampanel in Subjects with Amyotrophic Lateral Sclerosis (ALS) - ALSTAR | A Multinational, Multicenter, Randomized, Double-Blind, Placebo- Controlled, Parallel-Group Study to Assess the Efficacy, Tolerability and Safety of talampanel in Subjects with Amyotrophic Lateral Sclerosis (ALS) - ALSTAR | Amyotrophic Lateral Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10052653;Term: Amyotrophic lateral sclerosis gene carrier | Product Name: tallampanel Product Code: TV-7110 Product Name: talampanel | Teva Pharmaceutical Industries,Ltd | NULL | Not Recruiting | Female: yes Male: yes | 540 | Hungary;Germany;Netherlands;Belgium;France;Spain;Italy | |||
| 558 | NCT00694941 (ClinicalTrials.gov) | June 2008 | 6/6/2008 | A Phase II Multi-centre, Extension Study to Investigate the Long Term Safety of ONO-2506PO in Patients Diagnosed With Amyotrophic Lateral Sclerosis (ALS) | A Phase II Multi-centre, Extension Study to Investigate the Long Term Safety of ONO-2506PO in Patients Diagnosed With Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis (ALS) | Drug: ONO-2506PO | Ono Pharmaceutical Co. Ltd | NULL | Completed | 18 Years | N/A | Both | 15 | Phase 2 | Belgium;France;Germany;Italy;Netherlands;Switzerland;United Kingdom |
| 559 | NCT00877604 (ClinicalTrials.gov) | June 2008 | 7/4/2009 | Efficacy and Tolerability of Tauroursodeoxycholic Acid in Amyotrophic Lateral Sclerosis | A Randomized, Double-blind Multicenter Pilot Study vs. Placebo for the Evaluation of Efficacy and Tolerability of Tauroursodeoxycholic Acid Administered by Oral Route as Add on Treatment in Patients Affected by Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis | Drug: tauroursodeoxycholic acid (TUDCA);Drug: Placebo | Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta | University of Palermo;Federico II University | Completed | 18 Years | 75 Years | All | 34 | Phase 2 | Italy |
| 560 | NCT00919555 (ClinicalTrials.gov) | June 2008 | 8/6/2009 | Combination Therapy in Amyotrophic Lateral Sclerosis (ALS) | Phase IIA Trial: Tretinoin and Pioglitazone HCL Combination Therapy in Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis | Drug: Pioglitazone and Tretinoin;Drug: Tretinoin and Pioglitazone HCL;Drug: Placebo | Phoenix Neurological Associates, LTD | NULL | Completed | 18 Years | 85 Years | Both | 28 | Phase 1/Phase 2 | United States |
| 561 | EUCTR2007-004723-37-DE (EUCTR) | 16/05/2008 | 29/01/2008 | A Phase II multi-centre, extension study to investigate the long term safety of ONO-2506PO in patients diagnosed with Amyotrophic Lateral Sclerosis (ALS). | A Phase II multi-centre, extension study to investigate the long term safety of ONO-2506PO in patients diagnosed with Amyotrophic Lateral Sclerosis (ALS). | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 9.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral sclerosis | Product Name: ONO-2506PO Product Code: ONO-2506PO INN or Proposed INN: Arundic Acid Other descriptive name: (2R)-2-Propyloctanoic acid | ONO Pharmaceutical Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 273 | Phase 2 | United Kingdom;Germany;Belgium;France | ||
| 562 | EUCTR2007-004723-37-GB (EUCTR) | 12/05/2008 | 15/02/2008 | A Phase II multi-centre, extension study to investigate the long term safety of ONO-2506PO in patients diagnosed with Amyotrophic Lateral Sclerosis (ALS). | A Phase II multi-centre, extension study to investigate the long term safety of ONO-2506PO in patients diagnosed with Amyotrophic Lateral Sclerosis (ALS). | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 9.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral sclerosis | Product Name: ONO-2506PO Product Code: ONO-2506PO INN or Proposed INN: Arundic Acid Other descriptive name: (2R)-2-Propyloctanoic acid | ONO Pharmaceutical Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 273 | Phase 2 | Germany;United Kingdom;Belgium;France | ||
| 563 | NCT00790582 (ClinicalTrials.gov) | May 2008 | 12/11/2008 | A Multi-Center Controlled Screening Trial of Safety and Efficacy of Lithium Carbonate in Subjects With Amyotrophic Lateral Sclerosis (ALS) | A Multi-Center Controlled Screening Trial of Safety and Efficacy of Lithium Carbonate in Subjects With Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis | Drug: lithium carbonate | Forbes Norris MDA/ALS Research Center | Muscular Dystrophy Association | Completed | 21 Years | 80 Years | All | 109 | Phase 2 | United States |
| 564 | NCT00690118 (ClinicalTrials.gov) | May 2008 | 2/6/2008 | Study of Pioglitazone in Patients With Amyotrophic Lateral Sclerosis | Efficacy, Safety and Tolerability Study of 45 mg Pioglitazone in Patients With Amyotrophic Lateral Sclerosis (ALS) Receiving Standard Therapy (Riluzole) | Amyotrophic Lateral Sclerosis | Drug: pioglitazone;Drug: placebo | University of Ulm | NULL | Terminated | 18 Years | N/A | Both | 219 | Phase 2 | Germany;Italy |
| 565 | EUCTR2007-004723-37-BE (EUCTR) | 23/04/2008 | 31/01/2008 | A Phase II multi-centre, extension study to investigate the long term safety of ONO-2506PO in patients diagnosed with Amyotrophic Lateral Sclerosis (ALS). | A Phase II multi-centre, extension study to investigate the long term safety of ONO-2506PO in patients diagnosed with Amyotrophic Lateral Sclerosis (ALS). | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 9.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral sclerosis | Product Name: ONO-2506PO Product Code: ONO-2506PO INN or Proposed INN: Arundic Acid Other descriptive name: (2R)-2-Propyloctanoic acid | ONO Pharmaceutical Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 273 | Phase 2 | United Kingdom;Germany;Belgium;France | ||
| 566 | EUCTR2006-005410-13-DE (EUCTR) | 22/04/2008 | 21/01/2008 | EFFICACY, SAFETY AND TOLERABILITY STUDY OF 45 mg PIOGLITAZONE IN PATIENTS WITH AMYOTROPHIC LATERAL SCLEROSIS (ALS) RECEIVING STANDARD THERAPY (RILUZOLE). | EFFICACY, SAFETY AND TOLERABILITY STUDY OF 45 mg PIOGLITAZONE IN PATIENTS WITH AMYOTROPHIC LATERAL SCLEROSIS (ALS) RECEIVING STANDARD THERAPY (RILUZOLE). | Male or female adult patients with amyotrophic lateral sclerosis (ALS) accoring to the El Escorial Criteria for the diognosis of ALS and treated for at least 3 month with 100 mg riluzole (standard therapy). MedDRA version: 9.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral sclerosis | Trade Name: Actos 15 mg INN or Proposed INN: Pioglitazone Trade Name: Actos 30 mg INN or Proposed INN: Pioglitazone Trade Name: Actos 45 mg INN or Proposed INN: Pioglitazone | University Hospital of Ulm | NULL | Not Recruiting | Female: yes Male: yes | Germany | ||||
| 567 | EUCTR2007-004723-37-FR (EUCTR) | 15/04/2008 | 06/02/2008 | A Phase II multi-centre, extension study to investigate the long term safety of ONO-2506PO in patients diagnosed with Amyotrophic Lateral Sclerosis (ALS). | A Phase II multi-centre, extension study to investigate the long term safety of ONO-2506PO in patients diagnosed with Amyotrophic Lateral Sclerosis (ALS). | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 9.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral sclerosis | Product Name: ONO-2506PO Product Code: ONO-2506PO INN or Proposed INN: Arundic Acid Other descriptive name: (2R)-2-Propyloctanoic acid | ONO Pharmaceutical Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 273 | Phase 2 | France;Belgium;Germany;United Kingdom | ||
| 568 | EUCTR2008-001094-15-IT (EUCTR) | 10/03/2008 | 10/03/2008 | SINGLE-BLIND, RANDOMIZED, PARALLEL GROUP, DOSE-FINDING TRIAL ON LITHIUM FOR THE TREATMENT OFAMYOTROPHIC LATERAL SCLEROSIS (ALS) - ND | SINGLE-BLIND, RANDOMIZED, PARALLEL GROUP, DOSE-FINDING TRIAL ON LITHIUM FOR THE TREATMENT OFAMYOTROPHIC LATERAL SCLEROSIS (ALS) - ND | ALS patient according with the El-Escorial criteria MedDRA version: 9.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral sclerosis | Trade Name: CARBOLITHIUM*100CPS 150MG INN or Proposed INN: Lithium | AZIENDA SANITARIA OSPEDALIERA S. GIOVANNI BATTISTA DI TORINO | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Italy | ||||
| 569 | NCT00647296 (ClinicalTrials.gov) | March 2008 | 26/3/2008 | Safety and Tolerability Study of KNS-760704 in Amyotrophic Lateral Sclerosis (ALS) | A 2-Part, Randomized, Double-Blind, Safety and Tolerability Study Evaluating KNS-760704 in Patients With Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis | Drug: KNS-760704;Drug: Placebo | Knopp Biosciences | NULL | Completed | 21 Years | 80 Years | All | 102 | Phase 2 | United States |
| 570 | EUCTR2007-001592-10-IT (EUCTR) | 15/02/2008 | 15/01/2008 | A randomized, double-blind pilot study vs. placebo for the evaluation of efficacy and tolerability of tauroursodeoxycholicacid administered by oral route as add on treatment in patients affected by amyotrophic lateral sclerosis. - TUDCA-ALS | A randomized, double-blind pilot study vs. placebo for the evaluation of efficacy and tolerability of tauroursodeoxycholicacid administered by oral route as add on treatment in patients affected by amyotrophic lateral sclerosis. - TUDCA-ALS | AMYOTROPHIC LATERAL SCLEROSIS MedDRA version: 9.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral sclerosis | Product Name: Tauroursodeoxycholic acid INN or Proposed INN: Tauroursodeoxycholic acid | ISTITUTO NEUROLOGICO CARLO BESTA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Italy | ||||
| 571 | NCT00445172 (ClinicalTrials.gov) | February 2008 | 6/3/2007 | A Long-Term Study in Patients With Amyotrophic Lateral Sclerosis (ALS) | A Long-Term Study in Patients With Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis (ALS) | Drug: E0302 (mecobalamin) | Eisai Co., Ltd. | NULL | Completed | 20 Years | N/A | All | 135 | Phase 2/Phase 3 | Japan |
| 572 | EUCTR2007-002117-39-ES (EUCTR) | 31/01/2008 | 12/02/2008 | MEMANTINA (Ebixa X) PARA LA DISCAPACIDAD FUNCIONAL EN LA ESCLEROSIS LATERAL AMIOTRÓFICAMEMANTINE (Ebixa R) FOR FUNCTIONAL DISABILITY IN AMYOTROPHIC LATERAL SCLEROSIS . - MEDALS | MEMANTINA (Ebixa X) PARA LA DISCAPACIDAD FUNCIONAL EN LA ESCLEROSIS LATERAL AMIOTRÓFICAMEMANTINE (Ebixa R) FOR FUNCTIONAL DISABILITY IN AMYOTROPHIC LATERAL SCLEROSIS . - MEDALS | Esclerosis Lateral AmiotroficaAmyotrophic lateral Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral sclerosis | Trade Name: EBIXA INN or Proposed INN: MEMANTINE HYDROCHLORIDE | Jorge Matias-Guiu Guia | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 140 | Spain | |||
| 573 | NCT00561366 (ClinicalTrials.gov) | January 2008 | 16/11/2007 | A Multicenter, Double-Blind Study to Investigate the Safety and Efficacy of Arimoclomol in Volunteers With ALS | A Multicenter, Double-Blind, Placebo-Controlled, Phase 2b Study to Investigate the Safety and Efficacy of Arimoclomol in Volunteers With Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis | Drug: Placebo;Drug: Arimoclomol | CytRx | NULL | Withdrawn | 18 Years | N/A | Both | 0 | Phase 2 | United States;Canada |
| 574 | NCT00753571 (ClinicalTrials.gov) | January 2008 | 15/9/2008 | Cistanche Total Glycosides for Amyotrophic Lateral Sclerosis: A Randomized Control Trial (RCT) Study Assessing Clinical Response | Cistanche Total Glycosides Treatment for Amyotrophic Lateral Sclerosis: A Randomized Control Trial Study Assessing Clinical Response | Amyotrophic Lateral Sclerosis | Drug: Cistanche Total Glycosides | Peking University | NULL | Recruiting | 18 Years | 65 Years | Both | 40 | Phase 2 | China |
| 575 | NCT00573443 (ClinicalTrials.gov) | December 2007 | 13/12/2007 | Safety and Efficacy of AVP-923 in PBA Patients With ALS or MS | A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Safety and Efficacy and to Determine the Pharmacokinetics of Two Doses of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Pseudobulbar Affect (PBA) in Patients With Amyotrophic Lateral Sclerosis (ALS) and Multiple Sclerosis (MS) | Pseudobulbar Affect (PBA) | Drug: dextromethorphan hydrobromide 20 mg and quinidine sulfate 10 mg;Drug: dextromethorphan hydrobromide 30 mg and quinidine sulfate 10 mg;Drug: Placebo | Avanir Pharmaceuticals | INC Research | Completed | 18 Years | 80 Years | All | 326 | Phase 3 | United States;Argentina;Brazil |
| 576 | EUCTR2007-004165-17-IT (EUCTR) | 25/09/2007 | 15/10/2007 | Efficacy assessment of ceftriaxone therapy in patients with amyotrophic lateral sclerosis. - ND | Efficacy assessment of ceftriaxone therapy in patients with amyotrophic lateral sclerosis. - ND | Amyotrophic lateral sclerosis (ALS) MedDRA version: 6.1;Level: PT;Classification code 10002026 | INN or Proposed INN: Ceftriaxone | AZIENDA OSPEDALIERA PISANA | NULL | Not Recruiting | Female: yes Male: yes | Italy | ||||
| 577 | NCT00600873 (ClinicalTrials.gov) | August 2007 | 5/1/2008 | R(+)PPX High Dose Treatment of ALS | Pharmacokinetics and Nitrative-Oxidative Stress Pharmacodynamics in Amyotrophic Lateral Sclerosis Subjects Taking Daily High-Dose R(+) Pramipexole Dihydrochloride for Six Months | Amyotrophic Lateral Sclerosis | Drug: R(+) pramipexole dihydrochloride monohydrate | Bennett, James P., Jr., M.D., Ph.D. | NULL | Completed | 30 Years | 80 Years | Both | 10 | Phase 1/Phase 2 | United States |
| 578 | EUCTR2007-002379-16-IT (EUCTR) | 29/05/2007 | 09/11/2007 | MULTICENTER TRIAL (SINGLE BLIND)VS ON THE EFFICACY OF LITHIUM SALTS +RILUZOLE VS PLACEBO+RILUZOLE IN PATIENTS AFFECTED BY AMYOTROPHIC LATERAL SCLEROSIS - EFFICACY OF LITHIUM IN ALS | MULTICENTER TRIAL (SINGLE BLIND)VS ON THE EFFICACY OF LITHIUM SALTS +RILUZOLE VS PLACEBO+RILUZOLE IN PATIENTS AFFECTED BY AMYOTROPHIC LATERAL SCLEROSIS - EFFICACY OF LITHIUM IN ALS | Patients affected by amyotrophic lateral sclerosis (ALS) MedDRA version: 6.1;Level: PT;Classification code 10002026 | Trade Name: CARBOLITHIUM INN or Proposed INN: Lithium | I.N.M. NEUROMED (I.R.C.C.S.) S.R.L. GIA' SANATRIX | NULL | Not Recruiting | Female: yes Male: yes | Italy | ||||
| 579 | EUCTR2006-002660-26-NL (EUCTR) | 17/04/2007 | 03/01/2007 | A MULTI-CENTRE,RANDOMISED,DOUBLE BLIND,PLACEBO CONTROLLED,PARALLEL GROUP STUDY TO INVESTIGATE EFFICACY AND SAFETY OF ONO-2506PO COMPARED TO PLACEBO,IN THE PRESENCE OF RILUZOLE,TO PATIENTS DIAGNOSED WITH AMYOTROPHIC LATERAL SCLEROSIS(ALS), WHO HAVE HAD ONSET OF MUSCLE WEAKNESS WITHIN 14 MONTHS OF RANDOMISATION | A MULTI-CENTRE,RANDOMISED,DOUBLE BLIND,PLACEBO CONTROLLED,PARALLEL GROUP STUDY TO INVESTIGATE EFFICACY AND SAFETY OF ONO-2506PO COMPARED TO PLACEBO,IN THE PRESENCE OF RILUZOLE,TO PATIENTS DIAGNOSED WITH AMYOTROPHIC LATERAL SCLEROSIS(ALS), WHO HAVE HAD ONSET OF MUSCLE WEAKNESS WITHIN 14 MONTHS OF RANDOMISATION | Amyotrophic Lateral Sclerosis MedDRA version: 8.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral sclerosis | Product Name: ONO-2506PO Product Code: ONO-2506PO INN or Proposed INN: Arundic Acid Other descriptive name: (2R)-2-Propyloctanoic acid | ONO Pharmaceutical Co.,Ltd | NULL | Not Recruiting | Female: yes Male: yes | 392 | Germany;United Kingdom;Netherlands;Belgium;France;Italy;Austria | |||
| 580 | NCT00444613 (ClinicalTrials.gov) | April 2007 | 6/3/2007 | A Study in Patients With Amyotrophic Lateral Sclerosis (ALS) | A Phase II/III Study in Patients With Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis (ALS) | Drug: E0302 (mecobalamin);Drug: Placebo | Eisai Co., Ltd. | NULL | Completed | 20 Years | N/A | Both | 373 | Phase 2/Phase 3 | Japan |
| 581 | NCT00635960 (ClinicalTrials.gov) | March 2007 | 3/3/2008 | Growth Hormone in Amyotrophic Lateral Sclerosis | Efficacy, Safety and Tolerability of Growth Hormone in Patients With Amyotrophic Lateral Sclerosis as add-on Therapy to Riluzole | Amyotrophic Lateral Sclerosis | Drug: Growth Hormone (Somatropin);Drug: Placebo | Federico II University | Istituto Biostrutture e Immagini, CNR Naples;Agenzia Italiana del Farmaco | Completed | 40 Years | 85 Years | Both | 40 | Phase 2 | Italy |
| 582 | NCT00409721 (ClinicalTrials.gov) | March 2007 | 8/12/2006 | The Effect of Memantine on Functional Outcomes and Motor Neuron Degeneration in Amyotrophic Lateral Sclerosis (ALS) | A Randomized, Double-blind, Dose Ranging Study to Determine the Effect of Memantine on Functional Outcomes and Motor Neuron Degeneration in Patients With ALS | Amyotrophic Lateral Sclerosis | Drug: Memantine | University of Alberta | ALS Association | Completed | 18 Years | 80 Years | Both | 42 | Phase 2 | Canada |
| 583 | EUCTR2006-002660-26-IT (EUCTR) | 01/02/2007 | 10/11/2006 | A MULTI-CENTRE, RANDOMISED, DOUBLE BLIND, PLACEBO CONTROLLED, PARALLEL GROUP STUDY TO INVESTIGATE EFFICACY AND SAFETY OF ONO-2506PO COMPARED TO PLACEBO, IN THE PRESENCE OF RILUZOLE, TO PATIENTS DIAGNOSED WITH AMYOTROPHIC LATERAL SCLEROSIS ALS , WHO HAVE HAD ONSET OF MUSCLE WEAKNESS WITHIN 14 MONTHS OF RANDOMISATION - ND | A MULTI-CENTRE, RANDOMISED, DOUBLE BLIND, PLACEBO CONTROLLED, PARALLEL GROUP STUDY TO INVESTIGATE EFFICACY AND SAFETY OF ONO-2506PO COMPARED TO PLACEBO, IN THE PRESENCE OF RILUZOLE, TO PATIENTS DIAGNOSED WITH AMYOTROPHIC LATERAL SCLEROSIS ALS , WHO HAVE HAD ONSET OF MUSCLE WEAKNESS WITHIN 14 MONTHS OF RANDOMISATION - ND | Amyotrophic Lateral Sclerosis MedDRA version: 8.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral sclerosis | Product Name: ONO-2506 | ONO PHARMA UK LTD | NULL | Not Recruiting | Female: yes Male: yes | 392 | Germany;United Kingdom;Netherlands;Belgium;France;Italy;Austria | |||
| 584 | EUCTR2006-002660-26-GB (EUCTR) | 08/01/2007 | 20/09/2006 | A MULTI-CENTRE,RANDOMISED,DOUBLE BLIND,PLACEBO CONTROLLED,PARALLEL GROUP STUDY TO INVESTIGATE EFFICACY AND SAFETY OF ONO-2506PO COMPARED TO PLACEBO,IN THE PRESENCE OF RILUZOLE,TO PATIENTS DIAGNOSED WITH AMYOTROPHIC LATERAL SCLEROSIS(ALS), WHO HAVE HAD ONSET OF MUSCLE WEAKNESS WITHIN 14 MONTHS OF RANDOMISATION | A MULTI-CENTRE,RANDOMISED,DOUBLE BLIND,PLACEBO CONTROLLED,PARALLEL GROUP STUDY TO INVESTIGATE EFFICACY AND SAFETY OF ONO-2506PO COMPARED TO PLACEBO,IN THE PRESENCE OF RILUZOLE,TO PATIENTS DIAGNOSED WITH AMYOTROPHIC LATERAL SCLEROSIS(ALS), WHO HAVE HAD ONSET OF MUSCLE WEAKNESS WITHIN 14 MONTHS OF RANDOMISATION | Amyotrophic Lateral Sclerosis MedDRA version: 8.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral sclerosis | Product Name: ONO-2506PO Product Code: ONO-2506PO INN or Proposed INN: Arundic Acid Other descriptive name: (2R)-2-Propyloctanoic acid | ONO Pharmaceutical Co.,Ltd | NULL | Not Recruiting | Female: yes Male: yes | 392 | Germany;United Kingdom;Netherlands;Belgium;France;Italy;Austria | |||
| 585 | NCT00424463 (ClinicalTrials.gov) | January 2007 | 17/1/2007 | Expanded Controlled Study of Safety and Efficacy of MCI-186 in Patients With Amyotrophic Lateral Sclerosis (ALS) | An Expanded Controlled Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis in Double-Blind, Parallel-Group, Placebo-Controlled Manner (Phase 3) | Amyotrophic Lateral Sclerosis (ALS) | Drug: MCI-186;Drug: Placebo of MCI-186 | Mitsubishi Tanabe Pharma Corporation | NULL | Completed | 20 Years | N/A | All | 181 | Phase 3 | Japan |
| 586 | EUCTR2006-002660-26-DE (EUCTR) | 20/12/2006 | 19/01/2007 | A MULTI-CENTRE,RANDOMISED,DOUBLE BLIND,PLACEBO CONTROLLED,PARALLEL GROUP STUDY TO INVESTIGATE EFFICACY AND SAFETY OF ONO-2506PO COMPARED TO PLACEBO,IN THE PRESENCE OF RILUZOLE,TO PATIENTS DIAGNOSED WITH AMYOTROPHIC LATERAL SCLEROSIS(ALS), WHO HAVE HAD ONSET OF MUSCLE WEAKNESS WITHIN 14 MONTHS OF RANDOMISATION | A MULTI-CENTRE,RANDOMISED,DOUBLE BLIND,PLACEBO CONTROLLED,PARALLEL GROUP STUDY TO INVESTIGATE EFFICACY AND SAFETY OF ONO-2506PO COMPARED TO PLACEBO,IN THE PRESENCE OF RILUZOLE,TO PATIENTS DIAGNOSED WITH AMYOTROPHIC LATERAL SCLEROSIS(ALS), WHO HAVE HAD ONSET OF MUSCLE WEAKNESS WITHIN 14 MONTHS OF RANDOMISATION | Amyotrophic Lateral Sclerosis MedDRA version: 8.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral sclerosis | Product Name: ONO-2506PO Product Code: ONO-2506PO INN or Proposed INN: Arundic Acid Other descriptive name: (2R)-2-Propyloctanoic acid | ONO Pharmaceutical Co.,Ltd | NULL | Not Recruiting | Female: yes Male: yes | 392 | United Kingdom;Germany;Netherlands;Belgium;France;Italy;Austria | |||
| 587 | EUCTR2006-002660-26-FR (EUCTR) | 12/12/2006 | 10/10/2006 | A MULTI-CENTRE,RANDOMISED,DOUBLE BLIND,PLACEBO CONTROLLED,PARALLEL GROUP STUDY TO INVESTIGATE EFFICACY AND SAFETY OF ONO-2506PO COMPARED TO PLACEBO,IN THE PRESENCE OF RILUZOLE,TO PATIENTS DIAGNOSED WITH AMYOTROPHIC LATERAL SCLEROSIS(ALS), WHO HAVE HAD ONSET OF MUSCLE WEAKNESS WITHIN 14 MONTHS OF RANDOMISATION | A MULTI-CENTRE,RANDOMISED,DOUBLE BLIND,PLACEBO CONTROLLED,PARALLEL GROUP STUDY TO INVESTIGATE EFFICACY AND SAFETY OF ONO-2506PO COMPARED TO PLACEBO,IN THE PRESENCE OF RILUZOLE,TO PATIENTS DIAGNOSED WITH AMYOTROPHIC LATERAL SCLEROSIS(ALS), WHO HAVE HAD ONSET OF MUSCLE WEAKNESS WITHIN 14 MONTHS OF RANDOMISATION | Amyotrophic Lateral Sclerosis MedDRA version: 8.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral sclerosis | Product Name: ONO-2506PO Product Code: ONO-2506PO INN or Proposed INN: Arundic Acid Other descriptive name: (2R)-2-Propyloctanoic acid | ONO Pharmaceutical Co.,Ltd | NULL | Not Recruiting | Female: yes Male: yes | 392 | Phase 2 | France;Belgium;Austria;Germany;Netherlands;Italy;United Kingdom | ||
| 588 | NCT00397423 (ClinicalTrials.gov) | December 2006 | 8/11/2006 | G-CSF Treatment for Amyotrophic Lateral Sclerosis: A RCT Study Assessing Clinical Response | Granulocyte-Colony Stimulating Factor Treatment for Amyotrophic Lateral Sclerosis: A Randomized Control Trial Study Assessing Clinical Response | Amyotrophic Lateral Sclerosis | Drug: Granulocyte Colony Stimulating Factor;Drug: NS | Peking University | NULL | Completed | 18 Years | 65 Years | Both | 40 | Phase 2 | China |
| 589 | NCT00415519 (ClinicalTrials.gov) | December 2006 | 22/12/2006 | Efficacy and Safety Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis (ALS) Who Met Severity Classification III | An Exploratory Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis (Severity Classification III) in Double-Blind, Parallel-Group, Placebo-Controlled Manner | Amyotrophic Lateral Sclerosis (ALS) | Drug: MCI-186;Drug: Placebo of MCI-186 | Mitsubishi Tanabe Pharma Corporation | NULL | Completed | 20 Years | 75 Years | Both | 25 | Phase 3 | Japan |
| 590 | NCT00372879 (ClinicalTrials.gov) | December 2006 | 5/9/2006 | Clinical Trial of Vitamin E to Treat Muscular Cramps in Patients With ALS | Randomized Crossover Design Trial of Vitamin E vs Placebo for Treatment of Cramps in Amyotrophic Lateral Sclerosis. | Amyotrophic Lateral Sclerosis | Dietary Supplement: Vitamin E | Lawson Health Research Institute | NULL | Completed | 18 Years | N/A | Both | 32 | Phase 3 | Canada |
| 591 | EUCTR2006-002660-26-AT (EUCTR) | 13/11/2006 | 06/11/2006 | A MULTI-CENTRE,RANDOMISED,DOUBLE BLIND,PLACEBO CONTROLLED,PARALLEL GROUP STUDY TO INVESTIGATE EFFICACY AND SAFETY OF ONO-2506PO COMPARED TO PLACEBO,IN THE PRESENCE OF RILUZOLE,TO PATIENTS DIAGNOSED WITH AMYOTROPHIC LATERAL SCLEROSIS(ALS), WHO HAVE HAD ONSET OF MUSCLE WEAKNESS WITHIN 14 MONTHS OF RANDOMISATION | A MULTI-CENTRE,RANDOMISED,DOUBLE BLIND,PLACEBO CONTROLLED,PARALLEL GROUP STUDY TO INVESTIGATE EFFICACY AND SAFETY OF ONO-2506PO COMPARED TO PLACEBO,IN THE PRESENCE OF RILUZOLE,TO PATIENTS DIAGNOSED WITH AMYOTROPHIC LATERAL SCLEROSIS(ALS), WHO HAVE HAD ONSET OF MUSCLE WEAKNESS WITHIN 14 MONTHS OF RANDOMISATION | Amyotrophic Lateral Sclerosis MedDRA version: 8.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral sclerosis | Product Name: ONO-2506PO Product Code: ONO-2506PO INN or Proposed INN: Arundic Acid Other descriptive name: (2R)-2-Propyloctanoic acid | ONO Pharmaceutical Co.,Ltd | NULL | Not Recruiting | Female: yes Male: yes | 392 | Germany;United Kingdom;Netherlands;Belgium;France;Italy;Austria | |||
| 592 | EUCTR2006-002660-26-BE (EUCTR) | 13/11/2006 | 28/09/2006 | A MULTI-CENTRE,RANDOMISED,DOUBLE BLIND,PLACEBO CONTROLLED,PARALLEL GROUP STUDY TO INVESTIGATE EFFICACY AND SAFETY OF ONO-2506PO COMPARED TO PLACEBO,IN THE PRESENCE OF RILUZOLE,TO PATIENTS DIAGNOSED WITH AMYOTROPHIC LATERAL SCLEROSIS(ALS), WHO HAVE HAD ONSET OF MUSCLE WEAKNESS WITHIN 14 MONTHS OF RANDOMISATION | A MULTI-CENTRE,RANDOMISED,DOUBLE BLIND,PLACEBO CONTROLLED,PARALLEL GROUP STUDY TO INVESTIGATE EFFICACY AND SAFETY OF ONO-2506PO COMPARED TO PLACEBO,IN THE PRESENCE OF RILUZOLE,TO PATIENTS DIAGNOSED WITH AMYOTROPHIC LATERAL SCLEROSIS(ALS), WHO HAVE HAD ONSET OF MUSCLE WEAKNESS WITHIN 14 MONTHS OF RANDOMISATION | Amyotrophic Lateral Sclerosis MedDRA version: 8.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral sclerosis | Product Name: ONO-2506PO Product Code: ONO-2506PO INN or Proposed INN: Arundic Acid Other descriptive name: (2R)-2-Propyloctanoic acid | ONO Pharmaceutical Co.,Ltd | NULL | Not Recruiting | Female: yes Male: yes | 392 | Germany;United Kingdom;Netherlands;Belgium;France;Italy;Austria | |||
| 593 | NCT00403104 (ClinicalTrials.gov) | November 2006 | 22/11/2006 | Placebo Controlled Study of ONO2506PO in the Presence of Riluzole in Patients With Amyotrophic Lateral Sclerosis (ALS) | A Multi-centre, Randomized, Double Blind, Placebo-controlled, Parallel Group Study to Investigate Efficacy and Safety of ONO-2506PO Compared to Placebo, in the Presence of Riluzole, to Patients Diagnosed With Amyotrophic Lateral Sclerosis (ALS), Who Have Had Onset of Muscle Weakness Within 14 Months of Randomization | Amyotrophic Lateral Sclerosis (ALS) | Drug: ONO-2506PO | Ono Pharmaceutical Co. Ltd | NULL | Completed | 18 Years | 74 Years | Both | 420 | Phase 2 | Austria;Belgium;France;Germany;Italy;Netherlands;Switzerland;United Kingdom |
| 594 | EUCTR2006-001688-49-GB (EUCTR) | 14/08/2006 | 28/04/2006 | A multi-national, multi-centre, randomized, double-blind, placebo-controlled, parallel-group study to assess the efficacy, tolerability and safety of 40 mg glatiramer acetate injection in subjects with amyotrophic lateral sclerosis (ALS) - n.a. | A multi-national, multi-centre, randomized, double-blind, placebo-controlled, parallel-group study to assess the efficacy, tolerability and safety of 40 mg glatiramer acetate injection in subjects with amyotrophic lateral sclerosis (ALS) - n.a. | Early stage of amyotrophic lateral sclerosis (ALS) MedDRA version: 8.1;Level: PT;Classification code 10002026 | Product Name: 40 mg glatiramer acetate Product Code: 40 mg GA | TEVA Pharmaceutical Industries. Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 366 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Belgium;Germany;Italy;United Kingdom | ||
| 595 | EUCTR2006-001688-49-DE (EUCTR) | 31/07/2006 | 24/05/2006 | A multi-national, multi-centre, randomized, double-blind, placebo-controlled, parallel-group study to assess the efficacy, tolerability and safety of 40 mg glatiramer acetate injection in subjects with amyotrophic lateral sclerosis (ALS) - n.a. | A multi-national, multi-centre, randomized, double-blind, placebo-controlled, parallel-group study to assess the efficacy, tolerability and safety of 40 mg glatiramer acetate injection in subjects with amyotrophic lateral sclerosis (ALS) - n.a. | Early stage of amyotrophic lateral sclerosis (ALS) MedDRA version: 8.1;Level: PT;Classification code 10002026 | Product Name: 40 mg glatiramer acetate Product Code: 40 mg GA | TEVA Pharmaceutical Industries. Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 300 | United Kingdom;Germany;Belgium;Italy | |||
| 596 | NCT00355576 (ClinicalTrials.gov) | July 2006 | 21/7/2006 | Combination Therapy Selection Trial in Amyotrophic Lateral Sclerosis | Phase II Combination Therapy Selection Trial in Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis | Drug: Celecoxib;Drug: Creatine;Drug: Minocycline | Columbia University | ALS Association;Pfizer | Completed | 21 Years | 85 Years | Both | 86 | Phase 2 | United States |
| 597 | NCT00349622 (ClinicalTrials.gov) | July 2006 | 5/7/2006 | Clinical Trial Ceftriaxone in Subjects With ALS | Clinical Trial Ceftriaxone in Subjects With Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis;ALS | Drug: ceftriaxone;Other: placebo | Massachusetts General Hospital | National Institute of Neurological Disorders and Stroke (NINDS) | Completed | 18 Years | N/A | All | 513 | Phase 3 | United States;Canada;Puerto Rico |
| 598 | EUCTR2006-001688-49-BE (EUCTR) | 26/06/2006 | 10/05/2006 | A multi-national, multi-centre, randomized, double-blind, placebo-controlled, parallel-group study to assess the efficacy, tolerability and safety of 40 mg glatiramer acetate injection in subjects with amyotrophic lateral sclerosis (ALS) - n.a. | A multi-national, multi-centre, randomized, double-blind, placebo-controlled, parallel-group study to assess the efficacy, tolerability and safety of 40 mg glatiramer acetate injection in subjects with amyotrophic lateral sclerosis (ALS) - n.a. | Early stage of amyotrophic lateral sclerosis (ALS) MedDRA version: 8.1;Level: PT;Classification code 10002026 | Product Name: 40 mg glatiramer acetate Product Code: 40 mg GA | TEVA Pharmaceutical Industries. Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Germany;United Kingdom;Belgium;Italy | |||
| 599 | NCT00324454 (ClinicalTrials.gov) | May 2006 | 9/5/2006 | Levetiracetam for Cramps, Spasticity and Neuroprotection in Motor Neuron Disease | A Pilot Trial of Levetiracetam for Cramps, Spasticity and Neuroprotection in Motor Neuron Disease | Motor Neuron Disease;Amyotrophic Lateral Sclerosis;Primary Lateral Sclerosis;Progressive Muscular Atrophy | Biological: Levetiracetam | Duke University | UCB Pharma | Completed | 18 Years | N/A | Both | 20 | Phase 2 | United States |
| 600 | NCT00330681 (ClinicalTrials.gov) | May 2006 | 26/5/2006 | Efficacy and Safety Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis (ALS) | A Confirmatory Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis in Double-blind, Parallel-group, Placebo-controlled Manner. | Amyotrophic Lateral Sclerosis (ALS) | Drug: MCI-186;Drug: Placebo of MCI-186 | Mitsubishi Tanabe Pharma Corporation | NULL | Completed | 20 Years | 75 Years | All | 206 | Phase 3 | Japan |
| 601 | EUCTR2005-005152-40-IT (EUCTR) | 19/04/2006 | 07/04/2006 | MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, TRIAL ON ALPHA-LIPOIC ACID FOR THE TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS ALALS - ALALS | MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, TRIAL ON ALPHA-LIPOIC ACID FOR THE TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS ALALS - ALALS | ALS MedDRA version: 6.1;Level: PT;Classification code 10002026 | Product Name: ALPHA-LIPOIC ACID INN or Proposed INN: Tioctic acid | AZIENDA SANITARIA OSPEDALIERA S. GIOVANNI BATTISTA DI TORINO | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 84 | Italy | |||
| 602 | NCT00298597 (ClinicalTrials.gov) | March 2006 | 1/3/2006 | Influence of G-CSF and EPO on Associative Learning and Motor Skills | Influence of G-CSF and EPO on Associative Learning and Motor Skills | Chronic Stroke;Amyotrophic Lateral Sclerosis | Drug: granulocyte - colony stimulating factor (G-CSF);Drug: erythropoetin (EPO) | University Hospital Muenster | NULL | Completed | 18 Years | N/A | Both | 180 | Phase 2 | Germany |
| 603 | NCT00231140 (ClinicalTrials.gov) | December 2005 | 30/9/2005 | Pilot-Study of Thalidomide in Amyotrophic Lateral Sclerosis (ALS) | Randomized, Open, Parallel Group Study for the Evaluation of an Oral Dose of 100 mg Thalidomide and Subsequent Dose Escalation of 400 mg Thalidomide in Combination With Riluzole in Patients With Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis (ALS) | Drug: Thalidomide (drug) | Charite University, Berlin, Germany | NULL | Terminated | 25 Years | 80 Years | Both | 40 | Phase 2 | Germany |
| 604 | NCT00244244 (ClinicalTrials.gov) | October 2005 | 25/10/2005 | A Multicenter, Dose Ranging Safety and Pharmacokinetics Study of Arimoclomol in ALS | A Multicenter, Dose Ranging Safety and Pharmacokinetics Study of Arimoclomol in Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis (ALS) | Drug: arimoclomol | CytRx | NULL | Completed | 18 Years | N/A | Both | 80 | Phase 2 | United States |
| 605 | NCT00596115 (ClinicalTrials.gov) | October 2005 | 5/1/2008 | Treating Amyotrophic Lateral Sclerosis (ALS) With R(+) Pramipexole Dihydrochloride Monohydrate at 60 mg/Day | Open Label Extension for Treating ALS With R(+) Pramipexole at 60 Milligrams Per Day | Amyotrophic Lateral Sclerosis | Drug: R(+) pramipexole dihydrochloride monohydrate | Bennett, James P., Jr., M.D., Ph.D. | University of Pittsburgh;University of Nebraska | Temporarily not available | 30 Years | 80 Years | Both | N/A | NULL | |
| 606 | EUCTR2005-003248-75-IT (EUCTR) | 31/08/2005 | 02/09/2005 | PILOT STUDY ON SAFETY AND TOLERABILITY OF REPEATED MOBILIZATION PROCEDURES OF OSTEO-MEDULLARY DERIVED CELLS IN PATIENTS WITH AMYOTROPHIC LATERAL SCLEROSIS | PILOT STUDY ON SAFETY AND TOLERABILITY OF REPEATED MOBILIZATION PROCEDURES OF OSTEO-MEDULLARY DERIVED CELLS IN PATIENTS WITH AMYOTROPHIC LATERAL SCLEROSIS | SLOWING OF ALS PROGRESSION MedDRA version: 6.1;Level: PT;Classification code 10002026 | Trade Name: MYELOSTIM 34*1FL 263MCG+1SIR INN or Proposed INN: Lenograstim | AZIENDA SANITARIA OSPEDALIERA S. GIOVANNI BATTISTA DI TORINO | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Italy | ||||
| 607 | EUCTR2005-005873-31-IT (EUCTR) | 01/08/2005 | 14/03/2006 | A randomized, double-blind pilot study vs placebo for the evaluation of efficacy and tolerability of Erytropoietin administered by iv route as add-on treatment in patients affected by Amyotrophic Lateral Sclerosis ALS - ND | A randomized, double-blind pilot study vs placebo for the evaluation of efficacy and tolerability of Erytropoietin administered by iv route as add-on treatment in patients affected by Amyotrophic Lateral Sclerosis ALS - ND | Amiotrophic Lateral Sclerosis MedDRA version: 6.1;Level: PT;Classification code 10002026 | Trade Name: EPREX IV SC 1FL 1ML 40000 UI INN or Proposed INN: Erythropoietin | ISTITUTO NEUROLOGICO CARLO BESTA | NULL | Not Recruiting | Female: yes Male: yes | 20 | Italy | |||
| 608 | NCT00140218 (ClinicalTrials.gov) | August 2005 | 30/8/2005 | R(+) Pramipexole in Early Amyotrophic Lateral Sclerosis | Futility Study of R(+) Pramipexole in Early Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis | Drug: R(+) pramipexole dihydrochloride monohydrate | Bennett, James P., Jr., M.D., Ph.D. | University of Pittsburgh | Completed | 21 Years | 85 Years | Both | 30 | Phase 1/Phase 2 | United States |
| 609 | NCT00353665 (ClinicalTrials.gov) | July 2005 | 18/7/2006 | Memantine for Disability in Amyotrophic Lateral Sclerosis (MEDALS) | Phase 2-3 - Memantine for Disability in Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis | Drug: Memantine (Ebixa);Drug: riluzole;Drug: Placebo | University of Lisbon | H. Lundbeck A/S | Completed | 20 Years | 75 Years | Both | 63 | Phase 2/Phase 3 | Portugal |
| 610 | NCT01020331 (ClinicalTrials.gov) | June 2005 | 20/11/2009 | Memantine Therapy in Amyotrophic Lateral Sclerosis | Phase IIA Open Label Trial of Memantine in Combination With Riluzole (Customary Care) for the Treatment of ALS | Amyotrophic Lateral Sclerosis | Drug: Memantine | Phoenix Neurological Associates, LTD | Forest Laboratories | Completed | 18 Years | 85 Years | Both | 20 | Phase 2 | United States |
| 611 | EUCTR2004-004158-23-IT (EUCTR) | 15/04/2005 | 09/08/2007 | DOUBLE-BLIND PLACEBO-CONTROLLED TRIAL ON THE USE OF ACETYL-L-CARNITINE FOR THE TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS (ALS) - ND | DOUBLE-BLIND PLACEBO-CONTROLLED TRIAL ON THE USE OF ACETYL-L-CARNITINE FOR THE TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS (ALS) - ND | Amyotrophic lateral sclerosis therapy MedDRA version: 9.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral sclerosis | Trade Name: ZIBREN*20BUST 500MG INN or Proposed INN: Acetylcarnitine | IST. DI RICERCHE FARMACOLOG. M. NEGRI | NULL | Not Recruiting | Female: yes Male: yes | Italy | ||||
| 612 | NCT00812851 (ClinicalTrials.gov) | April 2005 | 21/11/2008 | Randomized Placebo-Controlled Crossover Trial With THC (Delta 9-Tetrahydrocannabinol) for the Treatment of Cramps in Amyotrophic Lateral Sclerosis (ALS) | Randomized Placebo-Controlled Crossover Trial With THC (Delta 9-Tetrahydrocannabinol) for the Treatment of Cramps in Amyotrophic Lateral Sclerosis (ALS) | Cramps;Amyotrophic Lateral Sclerosis | Drug: Dronabinol | Cantonal Hospital of St. Gallen | ALS Association | Completed | 18 Years | N/A | Both | 24 | N/A | Switzerland |
| 613 | NCT00136110 (ClinicalTrials.gov) | April 2005 | 24/8/2005 | Trial of Sodium Valproate in Amyotrophic Lateral Sclerosis | A Randomized, Double-Blind, Placebo-Controlled Sequential Clinical Trial of Sodium Valproate in ALS | Amyotrophic Lateral Sclerosis | Drug: Sodium Valproate | UMC Utrecht | Princess Beatrix Fund, The Netherlands | Completed | 18 Years | 85 Years | Both | 165 | Phase 3 | Netherlands |
| 614 | NCT00107770 (ClinicalTrials.gov) | April 2005 | 7/4/2005 | Safety Study of Oral Sodium Phenylbutyrate in Subjects With ALS (Amyotrophic Lateral Sclerosis) | Safety and Dose Escalating Study of Oral Sodium Phenylbutyrate in Subjects With Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis | Drug: sodium phenylbutyrate | Department of Veterans Affairs | Muscular Dystrophy Association | Completed | 18 Years | N/A | Both | 40 | Phase 1/Phase 2 | United States |
| 615 | NCT00243932 (ClinicalTrials.gov) | April 2005 | 24/10/2005 | Clinical Trial of High Dose CoQ10 in ALS | Clinical Trial of High Dose CoQ10 in ALS | Amyotrophic Lateral Sclerosis;Lou Gehrig's Disease | Drug: coenzyme Q10;Drug: Placebo | Columbia University | National Institute of Neurological Disorders and Stroke (NINDS) | Completed | 21 Years | 85 Years | All | 185 | Phase 2 | United States |
| 616 | NCT00140452 (ClinicalTrials.gov) | February 2005 | 31/8/2005 | Phase II Study Using Thalidomide for the Treatment of ALS | Phase II Study Using Thalidomide for the Treatment of Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis;ALS | Drug: Thalidomide | Dartmouth-Hitchcock Medical Center | Celgene Corporation | Completed | 18 Years | 80 Years | Both | 24 | Phase 2 | United States |
| 617 | EUCTR2004-002855-15-DE (EUCTR) | 29/12/2004 | 02/12/2004 | A long-term extension to a randomized, double-blind, placebo-controlled, stratified, parallel-group, multicenter, dose-ranging study evaluating four oral doses of TCH346 (1.0, 2.5, 7.5 and 15mg) administered once daily in patients with Amyotrophic Lateral Sclerosis. | A long-term extension to a randomized, double-blind, placebo-controlled, stratified, parallel-group, multicenter, dose-ranging study evaluating four oral doses of TCH346 (1.0, 2.5, 7.5 and 15mg) administered once daily in patients with Amyotrophic Lateral Sclerosis. | Amyotrophic Lateral Sclerosis | Product Code: TCH346 INN or Proposed INN: not established | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 480 | United Kingdom;Germany;Italy | |||
| 618 | EUCTR2004-002855-15-GB (EUCTR) | 21/12/2004 | 04/05/2005 | A long-term extension to a randomized, double-blind, placebo-controlled, stratified, parallel-group, multicenter, dose-ranging study evaluating four oral doses of TCH346 (1.0, 2.5, 7.5 and 15mg) administered once daily in patients with Amyotrophic Lateral Sclerosis. | A long-term extension to a randomized, double-blind, placebo-controlled, stratified, parallel-group, multicenter, dose-ranging study evaluating four oral doses of TCH346 (1.0, 2.5, 7.5 and 15mg) administered once daily in patients with Amyotrophic Lateral Sclerosis. | Amyotrophic Lateral Sclerosis | Product Code: TCH346 INN or Proposed INN: not established INN or Proposed INN: not established INN or Proposed INN: not established | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 480 | Germany;Italy;United Kingdom | |||
| 619 | EUCTR2004-002390-23-DE (EUCTR) | 24/11/2004 | 30/11/2004 | Evaluation of the pharmacokinetic profile of Riluzole (XRP4274) and RPR112512 following multiple oral administrations of XRP4274 for 8 days in healthy Japanese and Caucasian male subjects | Evaluation of the pharmacokinetic profile of Riluzole (XRP4274) and RPR112512 following multiple oral administrations of XRP4274 for 8 days in healthy Japanese and Caucasian male subjects | amyotrophic lateral sclerosis Classification code 10002026 | Trade Name: RILUTEK Product Name: RILUTEK 50 mg, film-coated tablets INN or Proposed INN: riluzole | Aventis Pharma Ltd. | NULL | Not Recruiting | Female: Male: yes | Germany | ||||
| 620 | EUCTR2004-002855-15-IT (EUCTR) | 09/11/2004 | 08/01/2007 | A long term extension to a randomised, double-blind, placebo-controlled, stratified, paralle-group, multicenter, dose-ranging study evaluating four oral doses of TCH346 1.0, 2.5, 7.5 and 15 mg administered once daily in patients with Amyotrophic Lateral Sclerosis | A long term extension to a randomised, double-blind, placebo-controlled, stratified, paralle-group, multicenter, dose-ranging study evaluating four oral doses of TCH346 1.0, 2.5, 7.5 and 15 mg administered once daily in patients with Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral sclerosis | Product Code: TCH346 Product Code: TCH346 Product Code: TCH346 | NOVARTIS FARMA | NULL | Not Recruiting | Female: yes Male: yes | 476 | United Kingdom;Germany;Italy | |||
| 621 | NCT00230074 (ClinicalTrials.gov) | November 2004 | 28/9/2005 | A Long-term Extension Study of TCH346 and Placebo Administered Once Daily in Patients With Amyotrophic Lateral Sclerosis(ALS) | A Long-term Extension Study of TCH346 and Placebo Administered Once Daily in Patients With Amyotrophic Lateral Sclerosis(ALS) | Amyotrophic Lateral Sclerosis | Drug: TCH346 | Novartis | NULL | Completed | 21 Years | 80 Years | Both | 350 | Phase 2 | United States |
| 622 | EUCTR2004-002912-27-ES (EUCTR) | 04/10/2004 | 27/04/2005 | Open-Label Extension Study to Investigate the Continued Safety and Effect of ONO 2506PO (1200 mg OD). | Open-Label Extension Study to Investigate the Continued Safety and Effect of ONO 2506PO (1200 mg OD). | Amyotrophic lateral sclerosis MedDRA version: 7.0;Level: LL 1;Classification code 10002026 | Product Name: ONO-2506PO Product Code: ONO-2506PO INN or Proposed INN: (R)-(-)-2-Propyloctaroic acid | ONO PHARMA UK LTD | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 2 | Spain | ||
| 623 | NCT00072709 (ClinicalTrials.gov) | September 2003 | 7/11/2003 | Study Evaluating TCH346 and Placebo Administered Once Daily in Patients With Amyotrophic Lateral Sclerosis (ALS) | A Randomized, Double-Blind, Placebo-Controlled, Stratified, Parallel-Group, Multicenter, Dose-Ranging Study Evaluating Four Oral Doses of TCH346 (1.0, 2.5, 7.5 and 15 mg) Administered Once Daily in Patients With Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis | Drug: TCH346 | Novartis Pharmaceuticals | NULL | Completed | 21 Years | 80 Years | Both | 551 | Phase 2 | United States;Belgium;Canada;France;Germany;Italy;Netherlands;Switzerland;United Kingdom |
| 624 | NCT00125203 (ClinicalTrials.gov) | July 2003 | 27/7/2005 | Study of Myobloc in the Treatment of Sialorrhea (Drooling) in Patients With Amyotrophic Lateral Sclerosis (ALS) | A Randomized, Double-Blind, Placebo-Controlled Study of Safety and Efficacy of Botulinum Toxin Type B (Myobloc) in Sialorrhea in Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis;Sialorrhea | Drug: Botulinum toxin type B (Myobloc);Procedure: Injection of salivary glands | The University of Texas Health Science Center at San Antonio | ALS Association;University of Kansas;Carolinas MDA Neuromuscular/ALS Center-Carolinas Medical System | Completed | 21 Years | 85 Years | Both | 20 | Phase 2/Phase 3 | United States |
| 625 | NCT00069186 (ClinicalTrials.gov) | June 2003 | 17/9/2003 | Study of Creatine Monohydrate in Patients With Amyotrophic Lateral Sclerosis | A Phase III, Multi-Center, Double-Blind, Placebo Controlled, Randomized Study of Creatine Monohydrate in Patients With Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis (ALS) | Drug: Creatine Monohydrate | The Avicena Group | NULL | Active, not recruiting | 21 Years | 80 Years | Both | 107 | Phase 3 | United States |
| 626 | NCT00035815 (ClinicalTrials.gov) | June 2003 | 6/5/2002 | Insulin-like Growth Factor-1 in Amyotrophic Lateral Sclerosis (ALS) Trial | Insulin-like Growth Factor-1 in Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis | Drug: Insulin like growth factor, type 1;Drug: Placebo | Mayo Clinic | National Institute of Neurological Disorders and Stroke (NINDS);ALS Association;Cephalon | Completed | 18 Years | 80 Years | All | 330 | Phase 3 | United States;Puerto Rico |
| 627 | NCT00047723 (ClinicalTrials.gov) | January 2003 | 16/10/2002 | Minocycline to Treat Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis | Drug: minocycline | National Institute of Neurological Disorders and Stroke (NINDS) | NULL | Completed | 21 Years | 85 Years | Both | 400 | Phase 3 | United States | |
| 628 | NCT00070993 (ClinicalTrials.gov) | December 2002 | 9/10/2003 | Creatine for the Treatment of Amyotrophic Lateral Sclerosis | Clinical Trial of Creatine in Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis | Drug: creatine monohydrate | National Center for Complementary and Integrative Health (NCCIH) | Office of Dietary Supplements (ODS) | Completed | 21 Years | 80 Years | Both | 110 | Phase 2 | United States |
| 629 | NCT00036413 (ClinicalTrials.gov) | January 2002 | 9/5/2002 | A 12-week, Multicenter, Safety and Dose-ranging Study of 3 Oral Doses of TCH346 in Patients With Amyotrophic Lateral Sclerosis | A 12-week, Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicenter, Safety and Dose-ranging Study of Three Oral Doses (0.5 mg, 2.5 mg and 10 mg Once Daily) of TCH346 in Patients With Amyotrophic Lateral Sclerosis. | Amyotrophic Lateral Sclerosis | Drug: TCH346 | Novartis Pharmaceuticals | NULL | Completed | 40 Years | 75 Years | Both | 44 | Phase 2 | United States |
| 630 | NCT00542412 (ClinicalTrials.gov) | January 2001 | 10/10/2007 | CARE Canadian ALS Riluzole Evaluation | Care (Canadian ALS Riluzole Evaluation) Multicentre Phase IV Comparative Study of the Effects of Riluzole 50mg Bid on the Survival of ALS Subjects Compared to Historical Controls | Amyotrophic Lateral Sclerosis | Drug: Riluzole | Sanofi | NULL | Completed | 18 Years | 75 Years | Both | 414 | Phase 4 | Canada |
| 631 | NCT00214110 (ClinicalTrials.gov) | January 2001 | 13/9/2005 | Tamoxifen Therapy in Amyotrophic Lateral Sclerosis [ALS] | Phase 2 Randomized Single-blind Escalating Dose Response Clinical Trial of Tamoxifen Therapy on Mean Percent Predicted Isometric Strength in Amyotrophic Lateral Sclerosis [ALS] | Amyotrophic Lateral Sclerosis (ALS) | Drug: Tamoxifen | University of Wisconsin, Madison | NULL | Completed | 18 Years | 90 Years | Both | 100 | Phase 2 | United States |
| 632 | NCT00021697 (ClinicalTrials.gov) | January 2001 | 1/8/2001 | Safety/Efficacy of AVP-923 in the Treatment of Emotional Lability (Uncontrolled Crying & Laughing) in Patients With ALS | A Double-Blind Controlled, Multicenter Phase II/III Study to Assess the Safety and Efficacy of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Pseudobulbar Affect in Patients With Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis | Drug: AVP-923 | Avanir Pharmaceuticals | NULL | Completed | 18 Years | 80 Years | Both | 100 | Phase 3 | United States |
| 633 | NCT00005766 (ClinicalTrials.gov) | May 2000 | 1/6/2000 | Clinical Trial of Creatine in Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis | Drug: Creatinine | National Center for Research Resources (NCRR) | NULL | Completed | 18 Years | 80 Years | Both | Phase 2 | United States | ||
| 634 | NCT00005674 (ClinicalTrials.gov) | May 2000 | 26/5/2000 | Clinical Trial of Creatine in Amyotrophic Lateral Sclerosis [ALS] | Amyotrophic Lateral Sclerosis | Drug: Creatine | National Center for Research Resources (NCRR) | Muscular Dystrophy Association | Completed | 18 Years | 80 Years | Both | Phase 2 | United States | ||
| 635 | NCT00004771 (ClinicalTrials.gov) | October 1992 | 24/2/2000 | Phase II Study of Leuprolide and Testosterone for Men With Kennedy's Disease or Other Motor Neuron Disease | Spinal Muscular Atrophy;Amyotrophic Lateral Sclerosis;Spinobulbar Muscular Atrophy | Drug: leuprolide;Drug: testosterone | National Center for Research Resources (NCRR) | Ohio State University | Completed | 18 Years | N/A | Male | 40 | Phase 2 | NULL | |
| 636 | EUCTR2020-005522-28-IT (EUCTR) | 09/08/2021 | A Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of ION363 in Amyotrophic Lateral Sclerosis Participants With Fused in Sarcoma Mutations (FUS-ALS). | A Phase 1-3 Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Intrathecally Administered ION363 in Amyotrophic Lateral Sclerosis Patients with Fused in Sarcoma Mutations (FUS-ALS) - FUSION: A Phase 1-3 study to evaluate the effects of ION363 in FUS-ALS patients | Amyotrophic Lateral Sclerosis with Fused in Sarcoma mutations MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ION363 Product Code: [ION363] Other descriptive name: all-P-ambo-2'-O-(2-methoxyethyl)-P-thioguanylyl-(3'-O->5'-O)-2'-O-(2-methoxyethyl)-5-methylcytidylyl-(3'-O->5'-O)-2'-O-(2-methoxyethyl)adenylyl-(3'-O->5'-O)-2'-O-(2-methoxyethyl)adenylyl-(3'-O->5'-O)-2'-O-(2-methoxyethyl)-5-methyluridylyl-(3'-O->5'-O)-2'-deoxy-P-thioguanylyl-(3'-O->5'-O)-P-thiothymidylyl-(3'-O->5'-O)-2'-deoxy-5-methyl-P-thiocytidylyl-(3'-O->5'-O)-2'-deoxy-Pthioadenylyl-(3'-O->5'-O)-2'-deoxy-5-methyl-P-thiocytidylyl-(3'-O->5'-O)-2'-deoxy- | IONIS PHARMACEUTICALS, INC. | NULL | NA | Female: yes Male: yes | 64 | Phase 1;Phase 3 | France;United States;Canada;Belgium;Turkey;Germany;United Kingdom;Japan;Italy;Korea, Republic of | |||
| 637 | EUCTR2020-005522-28-BE (EUCTR) | 13/08/2021 | A Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of ION363 in Amyotrophic Lateral Sclerosis Participants With Fused in Sarcoma Mutations (FUS-ALS). | A Phase 1-3 Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Intrathecally Administered ION363 in Amyotrophic Lateral Sclerosis Patients with Fused in Sarcoma Mutations (FUS-ALS) | Amyotrophic Lateral Sclerosis with Fused in Sarcoma mutations MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ION363 Product Code: ION363 INN or Proposed INN: Not assigned Other descriptive name: all-P-ambo-2'-O-(2-methoxyethyl)-P-thioguanylyl-(3'-O->5'-O)-2'-O-(2-methoxyethyl)-5-methylcytidylyl-(3'-O->5'-O)-2'-O-(2-methoxyethyl)adenylyl-(3'-O->5'-O)-2'-O-(2-methoxyethyl)adenylyl-(3'-O->5'-O)-2'-O-(2-methoxyethyl)-5-methyluridylyl-(3'-O->5'-O)-2'-deoxy-P-thioguanylyl-(3'-O->5'-O)-P-thiothymidylyl-(3'-O->5'-O)-2'-deoxy-5-methyl-P-thiocytidylyl-(3'-O->5'-O)-2'-deoxy-P-thioadenylyl-(3'-O->5'-O)-2'-deoxy-5-methyl-P-thiocytidylyl-(3'-O->5'-O)-2'-deoxy-5-methyl-P-thiocytidylyl-(3'-O->5'-O)-P-thiothymidylyl-(3'-O->5'-O)-P-thiothymidylyl-(3'-O->5'-O)-P-thiothymidylyl-(3'-O->5'-O)-2'-deoxy-5-methyl-P-thiocytidylyl-(3'-O->5'-O)-2'-O-(2-methoxyethyl)adenylyl-(3'-O->5'-O)-2'-O-(2-methoxyethyl)-5-methyluridylyl-(3'-O->5'-O)-2'-O-(2-methoxyethyl)-P-thioadenylyl-(3'-O->5'-O)-2'-O-(2-methoxyethyl)-5-methyl-P-thiocytidylyl-(3'-O->5'-O)-2'-O-(2-methoxyethyl)-5-methylcytidine | Ionis Pharmaceuticals, Inc. | NULL | NA | Female: yes Male: yes | 64 | Phase 1;Phase 2;Phase 3 | France;United States;Canada;Belgium;Korea, Democratic People's Republic of;Turkey;Germany;United Kingdom;Italy;Japan | |||
| 638 | EUCTR2020-004040-29-DE (EUCTR) | 09/04/2021 | A Clinical Study in which patients diagnosed with Amyotrophic Lateral Sclerosis (ALS) will receive Reldesemtiv (study drug). The safety and efficacy of the drug will be tested. | A Phase 3, Multi-center, Double Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Reldesemtiv in Patients with Amyotrophic Lateral Sclerosis (ALS). - COURAGE-ALS | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: reldesemtiv Product Code: CK-2127107 INN or Proposed INN: reldesemtiv Other descriptive name: RELDESEMTIV | Cytokinetics Inc | NULL | NA | Female: yes Male: yes | 555 | Phase 3 | Portugal;United States;Spain;Ireland;United Kingdom;Switzerland;Italy;France;Canada;Poland;Belgium;Australia;Germany;Netherlands;Sweden | |||
| 639 | EUCTR2020-005522-28-NL (EUCTR) | 27/05/2022 | A Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of ION363 in Amyotrophic Lateral Sclerosis Participants With Fused in Sarcoma Mutations (FUS-ALS). | A Phase 1-3 Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Intrathecally Administered ION363 in Amyotrophic Lateral Sclerosis Patients with Fused in Sarcoma Mutations (FUS-ALS) | Amyotrophic Lateral Sclerosis with Fused in Sarcoma mutations MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ION363 Product Code: ION363 INN or Proposed INN: Not assigned Other descriptive name: all-P-ambo-2'-O-(2-methoxyethyl)-P-thioguanylyl-(3'-O->5'-O)-2'-O-(2-methoxyethyl)-5-methylcytidylyl-(3'-O->5'-O)-2'-O-(2-methoxyethyl)adenylyl-(3'-O->5'-O)-2'-O-(2-methoxyethyl)adenylyl-(3'-O->5'-O)-2'-O-(2-methoxyethyl)-5-methyluridylyl-(3'-O->5'-O)-2'-deoxy-P-thioguanylyl-(3'-O->5'-O)-P-thiothymidylyl-(3'-O->5'-O)-2'-deoxy-5-methyl-P-thiocytidylyl-(3'-O->5'-O)-2'-deoxy-P-thioadenylyl-(3'-O->5'-O)-2'-deoxy-5-methyl-P-thiocytidylyl-(3'-O->5'-O)-2'-deoxy-5-methyl-P-thiocytidylyl-(3'-O->5'-O)-P-thiothymidylyl-(3'-O->5'-O)-P-thiothymidylyl-(3'-O->5'-O)-P-thiothymidylyl-(3'-O->5'-O)-2'-deoxy-5-methyl-P-thiocytidylyl-(3'-O->5'-O)-2'-O-(2-methoxyethyl)adenylyl-(3'-O->5'-O)-2'-O-(2-methoxyethyl)-5-methyluridylyl-(3'-O->5'-O)-2'-O-(2-methoxyethyl)-P-thioadenylyl-(3'-O->5'-O)-2'-O-(2-methoxyethyl)-5-methyl-P-thiocytidylyl-(3'-O->5'-O)-2'-O-(2-methoxyethyl)-5-methylcytidine | Ionis Pharmaceuticals, Inc. | NULL | NA | Female: yes Male: yes | 89 | Phase 1;Phase 2;Phase 3 | France;United States;Canada;Belgium;Brazil;Korea, Democratic People's Republic of;Turkey;Germany;Netherlands;United Kingdom;Italy;Japan | |||
| 640 | EUCTR2019-001862-13-IE (EUCTR) | 04/08/2020 | Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS) | A prospective, multicenter, randomised, double-blind, placebo-controlled, parallel groups, phase 3 study to compare the efficacy and safety of masitinib in combination with Riluzole versus placebo in combination with Riluzole in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - AB19001 ALS masitinib/placebo in combination with riluzole | patients suffering from Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Masitinib 100mg Product Code: AB1010 INN or Proposed INN: Masitinib Mesylate Product Name: Masitinib 200mg Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: na | AB Science | NULL | Not Recruiting | Female: yes Male: yes | 495 | Phase 3 | United States;Portugal;Slovenia;Spain;Ireland;Israel;Russian Federation;United Kingdom;Italy;France;Canada;Argentina;Belgium;Poland;Denmark;Norway;Germany;Netherlands;Sweden | |||
| 641 | EUCTR2019-001862-13-GB (EUCTR) | 24/03/2020 | Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS) | A prospective, multicenter, randomised, double-blind, placebo-controlled, parallel groups, phase 3 study to compare the efficacy and safety of masitinib in combination with Riluzole versus placebo in combination with Riluzole in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - AB19001 ALS masitinib/placebo in combination with riluzole | patients suffering from Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Masitinib 100mg Product Code: AB1010 INN or Proposed INN: Masitinib Mesylate Other descriptive name: na Product Name: Masitinib 200mg Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: na | AB Science | NULL | NA | Female: yes Male: yes | 495 | Phase 3 | United States;Portugal;Slovenia;Spain;Ireland;Russian Federation;Israel;United Kingdom;Italy;France;Canada;Argentina;Belgium;Poland;Denmark;Germany;Netherlands;Sweden | |||
| 642 | EUCTR2020-004040-29-BE (EUCTR) | 28/05/2021 | A Clinical Study in which patients diagnosed with Amyotrophic Lateral Sclerosis (ALS) will receive Reldesemtiv (study drug). The safety and efficacy of the drug will be tested. | A Phase 3, Multi-center, Double Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Reldesemtiv in Patients with Amyotrophic Lateral Sclerosis (ALS). - COURAGE-ALS | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: reldesemtiv Product Code: CK-2127107 INN or Proposed INN: reldesemtiv Other descriptive name: RELDESEMTIV | Cytokinetics Inc | NULL | NA | Female: yes Male: yes | 555 | Phase 3 | United States;Portugal;Spain;Ireland;Switzerland;Italy;United Kingdom;France;Canada;Belgium;Poland;Australia;Germany;Netherlands;Sweden | |||
| 643 | EUCTR2020-004040-29-FR (EUCTR) | 19/04/2021 | A Clinical Study in which patients diagnosed with Amyotrophic Lateral Sclerosis (ALS) will receive Reldesemtiv (study drug). The safety and efficacy of the drug will be tested. | A Phase 3, Multi-center, Double Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Reldesemtiv in Patients with Amyotrophic Lateral Sclerosis (ALS). - COURAGE-ALS | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: reldesemtiv Product Code: CK-2127107 INN or Proposed INN: reldesemtiv Other descriptive name: RELDESEMTIV | Cytokinetics Inc | NULL | NA | Female: yes Male: yes | 555 | Phase 3 | United States;Portugal;Spain;Ireland;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Poland;Australia;Germany;Netherlands;Sweden | |||
| 644 | EUCTR2012-004987-23-NL (EUCTR) | 07/02/2013 | A study in which patients suffering from amyotrophic lateral sclerosis (ALS) may be assigned randomly to receive either the treatment or placebo to look at how safe the product is, whether it has an effect and is easy to take. | A Phase IIb, multi-national, double-blind, randomised, placebo-controlled study to evaluate the safety, tolerability and efficacy of CK-2017357 in patients with amyotrophic lateral sclerosis (ALS) | Amyotrophic lateral sclerosis MedDRA version: 16.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Tirasemtiv Product Code: CK2017357 INN or Proposed INN: Tirasemtiv Other descriptive name: 6-ethynyl-1-(pentan-3-yl)-1H-imidazo[4,5-b]pyrazin-2(3H)-one Trade Name: Rilutek Product Name: Riluzole INN or Proposed INN: RILUZOLE | Cytokinetics Inc | NULL | Not Recruiting | Female: yes Male: yes | 680 | Phase 2 | France;United States;Canada;Spain;Ireland;Germany;Netherlands;United Kingdom | |||
| 645 | EUCTR2010-024423-24-IE (EUCTR) | 06/11/2014 | A controlled clinical study to investigate the effectiveness and safety of the medicine called masitinib when used together with a currently available medicine Riluzole when treating the illness called Amyotrophic Lateral Sclerosis (ALS) | A prospective, multicenter, randomised, double-blind, placebo-controlled, parallel groups, phase 2/3 Study to compare the efficacy and safety of masitinib versus placebo in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS). - IRELAND Phase 2/3 study comparing Masitinib/Placebo in ALS | Amyotrophic lateral Sclerosis MedDRA version: 18.0;Level: PT;Classification code 10028003;Term: Motor neurone disease;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 18.0;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Masitinib 100 mg Tablets Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: SUB126308 Product Name: Masitinib 200 mg Tablets Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: SUB126308 | AB Science | NULL | Not Recruiting | Female: yes Male: yes | 381 | Phase 2;Phase 3 | Portugal;United States;Slovakia;Greece;Spain;Ireland;Colombia;Italy;Switzerland;United Kingdom;France;Hungary;Mexico;Argentina;Belgium;Romania;Netherlands;Germany |