At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 90 enrolled
Drug / intervention
AMX0035drug
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.
Evaluation of the Safety, Tolerability, Efficacy, and Activity of AMX0035, a Fixed Combination of Phenylbutyrate (PB) and Tauroursodeoxycholic Acid (TUDCA), for Treatment of Amyotrophic Lateral Sclerosis: Open-Label Extension
In Brief
A Phase 2 clinical trial evaluating AMX0035 for Amyotrophic Lateral Sclerosis and ALS. Completed, enrolled 90 participants across 24 sites.
Detailed Summary
This extension study, in which all participants received active treatment (AMX0035), was designed to assess the longer-term safety and therapeutic potential of AMX0035 for participants who have completed the Main Study (AMX3500, also known as CENTAUR).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAmyotrophic Lateral Sclerosis, ALS
CountriesUnited States
CollaboratorsMassachusetts General Hospital
Timeline
Phase 2CompletedFinished
20192020202120222023202420252026
Enrollment StartMar 2018
First PostedApr 2018
Primary CompletionMar 2021
TodayJul 2026
First PostedApr 5, 2018
Enrollment StartMar 29, 2018
Primary CompletionMar 1, 2021
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 8.2 years ago
Interventions
AMX0035drug
Combination therapy of PB and TURSO