Trials / Terminated
TerminatedNCT04948645
A Phase 1 Study to Investigate the Safety and Pharmacokinetics of Fosigotifator in Patients With Amyotrophic Lateral Sclerosis
A Randomized, Double-Blind, Placebo-Controlled Study to Assess Safety, Tolerability, and Pharmacokinetics Following Multiple Doses of Fosigotifator in Subjects With Amyotrophic Lateral Sclerosis Followed by an Active Treatment Extension
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 31 (actual)
- Sponsor
- AbbVie · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
Fosigotifator is an investigational drug being researched for the treatment of Amyotrophic Lateral Sclerosis. This is an up to 156-week, 2-part study. Part 1 will be a 4-week, randomized, double-blind, placebo-controlled study; Part 2 will be up to a 152-week active treatment extension (ATE) during which all subjects will receive Fosigotifator.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Fosigotifator | Oral |
| DRUG | Placebo | Oral |
Timeline
- Start date
- 2021-09-22
- Primary completion
- 2025-07-15
- Completion
- 2025-07-15
- First posted
- 2021-07-02
- Last updated
- 2025-08-01
Locations
14 sites across 2 countries: United States, Canada
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04948645. Inclusion in this directory is not an endorsement.