Trials / Completed
CompletedNCT03491462
Arimoclomol in Amyotropic Lateral Sclerosis
A Phase 3, Randomised, Placebo-Controlled Trial of Arimoclomol in Amyotropic Lateral Sclerosis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 245 (actual)
- Sponsor
- ZevraDenmark · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
A multicenter, randomized, double-blind, placebo-controlled, parallel group trial to evaluate the efficacy and safety of arimoclomol in amyotropic lateral sclerosis (ALS)
Detailed description
Screening up to 4 weeks Treatment up to 76 weeks
Conditions
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 |
| DRUG | Placebo | 2 matched placebo capsules taken 3 times daily |
Timeline
- Start date
- 2018-07-31
- Primary completion
- 2020-12-18
- Completion
- 2020-12-18
- First posted
- 2018-04-09
- Last updated
- 2023-08-24
- Results posted
- 2023-08-24
Locations
29 sites across 12 countries: United States, Belgium, Canada, France, Germany, Italy, Netherlands, Poland, Spain, Sweden, Switzerland, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03491462. Inclusion in this directory is not an endorsement.