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Study to Assess the Effects of PTC857 Treatment in Participants With Amyotrophic Lateral Sclerosis ALS — CARDINALS  

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:
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)

Clinical Trial Summary

This study will assess the efficacy and safety of PTC857 treatment in participants diagnosed with ALS.

Clinical Trial Description

Participants will be randomized to 1 of the 2 treatment groups: PTC857 or matching placebo. Following successful completion of the Treatment Period, participants who enter the LTE Period, will receive open-label PTC857 for 28 weeks. Following completion of the LTE period, participants who enter the Continued LTE Period will receive open-label PTC857 for an additional 108 weeks. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05349721
Study type Interventional
Source PTC Therapeutics
Contact
Status Active, not recruiting
Phase Phase 2
Start date May 15, 2022
Completion date February 28, 2025
View Details
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