2. 筋萎縮性側索硬化症 Amyotrophic lateral sclerosis Clinical trials / Disease details
臨床試験数 : 624 / 薬物数 : 611 - (DrugBank : 160) / 標的遺伝子数 : 172 - 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 | 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 | ||
| 2 | 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 | ||
| 3 | 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 | ||
| 4 | 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 | ||
| 5 | 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 | ||
| 6 | 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 |
| 7 | 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 |
| 8 | 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 | ||
| 9 | 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 | ||
| 10 | 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 | |
| 11 | 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 | ||
| 12 | 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 | ||
| 13 | 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 | |
| 14 | 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 |
| 15 | 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 | ||
| 16 | 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 |
| 17 | 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: Trametinib (2 mg);Drug: Riluzole (100 mg) | GENUV Inc. | NULL | Recruiting | 19 Years | 75 Years | All | 30 | Phase 1/Phase 2 | Korea, Republic of |
| 18 | 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 | ||
| 19 | 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 | ||
| 20 | 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 | ||
| 21 | 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 |
| 22 | 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 |
| 23 | 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 |
| 24 | 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 |
| 25 | 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 |
| 26 | 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 | ||
| 27 | 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 | |||
| 28 | 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 |
| 29 | 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 |
| 30 | 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 | ||
| 31 | 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 |
| 32 | 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 | ||
| 33 | 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 | |||
| 34 | 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 |
| 35 | 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 | ||
| 36 | 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 | ||
| 37 | 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 |
| 38 | 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 |
| 39 | JPRN-UMIN000006423 | 2011/10/01 | 01/10/2011 | The clinical trial to assess efficacy of mexiletine for 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 | |
| 40 | 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 |
| 41 | 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 | |||
| 42 | 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 | ||||
| 43 | 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 |
| 44 | 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 |
| 45 | 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 | |||
| 46 | 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 |
| 47 | 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 | ||
| 48 | 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 | ||
| 49 | 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 | ||
| 50 | 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 | ||||
| 51 | 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 | ||
| 52 | 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 |
| 53 | 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 | ||||
| 54 | 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 | ||
| 55 | 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 |
| 56 | 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 | ||||
| 57 | 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 | ||||
| 58 | 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 |
| 59 | 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 | ||||
| 60 | 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 | |||
| 61 | 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 |
| 62 | 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 | |||
| 63 | 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 | |||
| 64 | 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 | |||
| 65 | 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 | ||
| 66 | 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 | |||
| 67 | 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 | |||
| 68 | 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 |
| 69 | 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 |
| 70 | 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 |
| 71 | 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 |
| 72 | 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 | ||||
| 73 | 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 |
| 74 | 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 | |||
| 75 | 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 | |||
| 76 | 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 | |||
| 77 | 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 |