NCT03836716

Arimoclomol in Amyotropic Lateral Sclerosis - Open Label Extension Trial

Open Label, Non-randomized Extension Trial to Assess Long Term Safety and Efficacy of Arimoclomol in Subjects With Amyotropic Lateral Sclerosis Who Have Completed the ORARIALS-01 Trial

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: ZevraDenmark · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The planned duration of the open-label trial was 152 weeks, but the trial was terminated early as a consequence of the results of ORARIALS-01 which did not meet any of its efficacy endpoints. Therefore, the actual mean duration of open-label treatment was approximately 28 weeks (range approximately 2 to 71 weeks).

Conditions

• Amyotrophic Lateral Sclerosis

Interventions

Type	Name	Description
DRUG	Arimoclomol	2 capsules (2 x 124 mg arimoclomol base; equivalent to 2 x 200 mg arimoclomol citrate) taken 3 times daily

Timeline

• Start date: 2019-09-19
• Primary completion: 2021-07-02
• Completion: 2021-07-02
• First posted: 2019-02-11
• Last updated: 2023-08-24
• Results posted: 2023-08-24

Locations

23 sites across 11 countries: United States, Belgium, Canada, France, Germany, Italy, Netherlands, Poland, Spain, Sweden, United Kingdom

Regulatory

• FDA-regulated drug study