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Safety and Efficacy of TUDCA as add-on Treatment in Patients Affected by ALS — TUDCA-ALS  

Amyotrophic Lateral Sclerosis (ALS) Clinical Trial

Official title:
Safety and Efficacy of Tauroursodeoxycholic (TUDCA) as add-on Treatment in Patients Affected by Amyotrophic Lateral Sclerosis (ALS)

Clinical Trial 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).

Clinical Trial Description

Enrolled patients will be randomized to one of two treatment arms: TUDCA or identical placebo by oral route. The randomization will be performed in a ratio one to one for the two arms. TUDCA will be administered orally at the dose of 1 g twice daily (2 g daily) for 18 months. Patients will be taking also riluzole at the dose of 50 mg twice daily (100 mg daily). Patient randomization will take place after a screening (lead-in) period of 12 weeks (3 months) with 3 assessments at 6-week intervals. Clinical assessments during the trial phase will be performed every three months. This will allow measuring the progression rate before and after starting treatment (either active or placebo). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03800524
Study type Interventional
Source Humanitas Mirasole SpA
Contact
Status Active, not recruiting
Phase Phase 3
Start date February 22, 2019
Completion date December 31, 2023
View Details
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