Trials / Terminated
TerminatedNCT04248465
An Efficacy and Safety Study of Ravulizumab in ALS Participants
A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter Study With an Open-Label Extension to Evaluate the Efficacy and Safety of Ravulizumab in Patients With Amyotrophic Lateral Sclerosis (ALS)
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 382 (actual)
- Sponsor
- Alexion Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the study is to assess the efficacy and safety of ravulizumab for the treatment of adult participants with ALS.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Placebo | Single loading dose via intravenous infusion, followed by regular maintenance dosing, based on weight. |
| BIOLOGICAL | Ravulizumab | Single loading dose via intravenous infusion, followed by regular maintenance dosing, based on weight. |
Timeline
- Start date
- 2020-03-30
- Primary completion
- 2021-10-17
- Completion
- 2021-10-17
- First posted
- 2020-01-30
- Last updated
- 2023-01-10
- Results posted
- 2023-01-10
Locations
95 sites across 17 countries: United States, Australia, Belgium, Canada, Denmark, France, Germany, Ireland, Israel, Italy, Japan, Netherlands, Poland, Spain, Sweden, Switzerland, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04248465. Inclusion in this directory is not an endorsement.