CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 137 enrolled
Drug / intervention
AMX0035 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03127514
NCT03127514Phase 2Completed
CompareCT.gov

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

Amylyx Pharmaceuticals Inc.·interventional·Posted Apr 25, 2017·Updated May 16, 2024

In Brief

A Phase 2 clinical trial evaluating AMX0035 and Placebo for Amyotrophic Lateral Sclerosis and 7 related conditions. Completed, enrolled 137 participants across 25 sites.

Detailed Summary

The CENTAUR trial was a 2:1 (active:placebo) randomized, double-blind, placebo-controlled Phase II trial to evaluate the safety and efficacy of AMX0035 for the treatment of ALS.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAmyotrophic Lateral Sclerosis, Motor Neuron Disease, Neuromuscular Diseases, Neurodegenerative Diseases, Spinal Cord Diseases, TDP-43 Proteinopathies, Nervous System Diseases, Central Nervous System Diseases
CountriesUnited States
CollaboratorsALS Finding a Cure, ALS Association, Northeast ALS Consortium, Neurological Clinical Research Institute at Massachusetts General Hospital, Leandro P. Rizzuto Foundation

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedApr 25, 2017
Enrollment StartJun 22, 2017
Primary CompletionSep 25, 2019
Study CompletionNov 24, 2019
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 9.2 years ago

Interventions

AMX0035drug

AMX0035

Placeboother

Matching Placebo Comparator