2. Amyotrophic lateral sclerosis Clinical trials / Disease details
Clinical trials : 624 / Drugs : 611 - (DrugBank : 160) / Drug target genes : 172 - Drug target pathways : 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 | 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 | ||
| 2 | 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 | ||
| 3 | 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 | ||
| 4 | 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 | ||
| 5 | 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 | ||
| 6 | 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 | Recruiting | 18 Years | 80 Years | All | 440 | Phase 3 | Belgium;France;Germany;Ireland;Italy;Netherlands;United Kingdom |
| 7 | 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 | ||
| 8 | 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 |
| 9 | 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 |
| 10 | 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 |