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NCT04948645 · ClinicalTrials.gov registry record · Phase 1
A Phase 1 Study to Investigate the Safety and Pharmacokinetics of Fosigotifator in Patients With Amyotrophic Lateral Sclerosis
A Phase 1 study, sponsored by AbbVie.
- Terminated
- Registry status
- Phase 1
- Development phase
- 31
- Enrollment target
NCT04948645: Clinical Trial Phase 1 study, sponsored by AbbVie.
NCT04948645 is a Phase 1 study that was terminated before completion, run by AbbVie. The registered enrollment target is 31 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04948645, a Phase 1 study, was terminated before completion, sponsored by AbbVie.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 31 participants
- Enrollment target
Study 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.
Primary Outcome
Number of patients with treatment-related adverse events as assessed by CTCAE v4.03
Interventions
- DRUG Placebo
- DRUG Fosigotifator
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2021-09-22 |
| Est. Completion | 2025-07-15 |
| Phase | Phase 1 |
Why NCT04948645 stopped before completion
NCT04948645 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04948645 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04948645 about?
NCT04948645 is a clinical study titled "A Phase 1 Study to Investigate the Safety and Pharmacokinetics of Fosigotifator in Patients With Amyotrophic Lateral Sclerosis". 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 ...
What is the current status of trial NCT04948645?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2021-09-22. Estimated completion is 2025-07-15.
What interventions are being tested in trial NCT04948645?
The interventions under investigation include: Placebo (DRUG), Fosigotifator (DRUG).
Who is sponsoring clinical trial NCT04948645?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04948645's enrollment target sits among peer trials
31 1322nd of 2000 higher than 669 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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