drugset / Trial / NCT03800524
Safety and Efficacy of TUDCA as add-on Treatment in Patients Affected by ALS
Phase 3
Unknown
337 enrolled
Humanitas Mirasole SpA
Bruschettini S.r.l. · collabEuropean Commission · collabIstituto Superiore di Sanità · collabKU Leuven · collabMotor Neurone Disease Association · collabUMC Utrecht · collabUniversity Hospital, Tours · collabUniversity of Dublin, Trinity College · collabUniversity of Sheffield · collabUniversity of Ulm · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This is a Phase III, multi-centre, randomized, double-blind, placebo-controlled, parallel-group study to evaluate Safety and Efficacy of Tauroursodeoxycholic (TUDCA) as add-on Treatment in Patients Affected by Amyotrophic Lateral Sclerosis (ALS).
Timeline
- Start
- 2019-02-22
- Primary completion
- 2023-12-31
- Completion
- 2023-12-31
Publications
- Background Albanese A, Ludolph AC, McDermott CJ, Corcia P, Van Damme P, Van den Berg LH, Hardiman O, Rinaldi G, Vanacore N, Dickie B; TUDCA-ALS Study Group. Tauroursodeoxycholic acid in patients with amyotrophic lateral sclerosis: The TUDCA-ALS trial protocol. Front Neurol. 2022 Sep 27;13:1009113. doi: 10.3389/fneur.2022.1009113. eCollection 2022.
- Lombardo FL, Spila Alegiani S, Mayer F, Cipriani M, Lo Giudice M, Ludolph AC, McDermott CJ, Corcia P, Van Damme P, Van den Berg LH, Hardiman O, Nicolini G, Vanacore N, Dickie B, Albanese A, Puopolo M; TUDCA-ALS Study Group. A randomized double-blind clinical trial on safety and efficacy of tauroursodeoxycholic acid (TUDCA) as add-on treatment in patients affected by amyotrophic lateral sclerosis (ALS): the statistical analysis plan of TUDCA-ALS trial. Trials. 2023 Dec 5;24(1):792. doi: 10.1186/s13063-023-07638-w.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Taurursodiol | Small molecule | 1 g | Oral |