drugset / Trial / NCT03836716

Arimoclomol in Amyotropic Lateral Sclerosis - Open Label Extension Trial

NCT03836716 ↗

Phase 3 Terminated 120 enrolled ZevraDenmark
NaSingle-groupOpen-labelTreatment

Summary

A multicenter, non-randomized, open label trial, to assess long term safety and efficacy of Arimoclomol in subjects with Amyotrophic Lateral Sclerosis (ALS) who have completed the ORARIALS-01 trial.

Timeline

Start
2019-09-19
Primary completion
2021-07-02
Completion
2021-07-02

Outcome

Outcome not reported

Stopped: “As a consequence of the results of ORARIALS-01 which did not meet any of its efficacy endpoints. The planned duration was 152 weeks. After termination, the actual mean duration of treatment was approx. 28 weeks (range approx. 2 to 71 weeks).”

Drugs

EvaluationDrugModalityDoseRoute
Subject Arimoclomol Small molecule 248 mg —