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NCT04288856 · ClinicalTrials.gov registry record · Phase 1
Study to Assess the Safety, Tolerability, Pharmacokinetics, and Effect on Disease Progression of BIIB078 Administered to Previously Treated Adults C9ORF72-Associated Amyotrophic Lateral Sclerosis (ALS)
A Phase 1 study, sponsored by Biogen.
- Terminated
- Registry status
- Phase 1
- Development phase
- 75
- Enrollment target
NCT04288856: Clinical Trial Phase 1 study, sponsored by Biogen.
NCT04288856 is a Phase 1 study that was terminated before completion, run by Biogen. The registered enrollment target is 75 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04288856, a Phase 1 study, was terminated before completion, sponsored by Biogen.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 75 participants
- Enrollment target
Study Summary
The primary objective is to evaluate the long-term safety and tolerability of BIIB078 in participants with chromosome 9 open reading frame 72-amyotrophic lateral sclerosis (C9ORF72-ALS). The secondary objective is to evaluate the pharmacokinectic (PK) of BIIB078 in participants with C9ORF72-ALS.
Primary Outcome
AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention.
Interventions
- DRUG BIIB078
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2020-04-28 |
| Est. Completion | 2022-05-03 |
| Phase | Phase 1 |
Why NCT04288856 stopped before completion
NCT04288856 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% higher).
The record links to 0 conditions, and to 1 intervention - of which BIIB078 is the first listed.
NCT04288856 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04288856 about?
NCT04288856 is a clinical study titled "Study to Assess the Safety, Tolerability, Pharmacokinetics, and Effect on Disease Progression of BIIB078 Administered to Previously Treated Adults C9ORF72-Associated Amyotrophic Lateral Sclerosis (ALS)". The primary objective is to evaluate the long-term safety and tolerability of BIIB078 in participants with chromosome 9 open reading frame 72-amyotrophic lateral sclerosis (C9ORF72-ALS). The secondary objective is to evaluate the pharmacokinectic (PK) of BIIB078 in participants with C9ORF72-ALS.
What is the current status of trial NCT04288856?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 75 participants. The study started on 2020-04-28. Estimated completion is 2022-05-03.
What interventions are being tested in trial NCT04288856?
The interventions under investigation include: BIIB078 (DRUG).
Who is sponsoring clinical trial NCT04288856?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04288856's enrollment target sits among peer trials
75 711th of 2000 higher than 1,276 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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