NCT03488524

Open Label Extension Study of AMX0035 in Patients With ALS

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Amylyx Pharmaceuticals Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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).

Detailed description

The Centaur Open Label Extension Study (CENTAUR-OLE) is an extension study for patients with ALS who participated in the CENTAUR study (Study AMX3500). During the OLE, all participants received active treatment (AMX0035), and the investigators, evaluators, and participants remained blinded to the randomized treatment assigned at the beginning of the double-blind main study. The study was designed to assess the longer term safety and therapeutic potential of AMX0035.

Conditions

• Amyotrophic Lateral Sclerosis
• ALS

Interventions

Type	Name	Description
DRUG	AMX0035	Combination therapy of PB and TURSO

Timeline

• Start date: 2018-03-29
• Primary completion: 2021-03-01
• Completion: 2021-03-01
• First posted: 2018-04-05
• Last updated: 2025-08-13
• Results posted: 2025-08-13

Locations

24 sites across 1 country: United States

Regulatory

• FDA-regulated drug study