Trials / Completed
CompletedNCT05178810
Study to Investigate the Efficacy and Safety of FAB122 (Daily Oral Edaravone) in Patients With Amyotrophic Lateral Sclerosis
A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of FAB122 in Patients With Amyotrophic Lateral Sclerosis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 313 (actual)
- Sponsor
- Ferrer Internacional S.A. · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
Multicenter, multinational, double-blind, randomized (2:1), placebo-controlled Phase III study to investigate the efficacy and safety of 100 mg FAB122 once daily as oral formulation in ALS patients.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | FAB122 | Daily dose 100 mg |
| DRUG | Placebo | Daily dose |
Timeline
- Start date
- 2021-10-18
- Primary completion
- 2023-10-26
- Completion
- 2023-10-26
- First posted
- 2022-01-05
- Last updated
- 2025-03-18
- Results posted
- 2025-03-18
Locations
38 sites across 11 countries: Belgium, France, Germany, Ireland, Italy, Netherlands, Poland, Portugal, Spain, Sweden, United Kingdom
Source: ClinicalTrials.gov record NCT05178810. Inclusion in this directory is not an endorsement.