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NCT03626012 · ClinicalTrials.gov registry record · Phase 1
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of BIIB078 in Adults With C9ORF72-Associated Amyotrophic Lateral Sclerosis
A Phase 1 study, sponsored by Biogen.
- Completed
- Registry status
- Phase 1
- Development phase
- 106
- Enrollment target
NCT03626012: Completed Phase 1 study, sponsored by Biogen.
NCT03626012 is a Phase 1 study that has completed, run by Biogen. The registered enrollment target is 106 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03626012, a Phase 1 study, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 106 participants
- Enrollment target
Study Summary
The primary objective of this study is to evaluate the safety and tolerability of BIIB078 in adults with C9ORF72-Amyotrophic Lateral Sclerosis (ALS). The secondary objectives of this study are to evaluate the pharmacokinetic profile of BIIB078 and to evaluate the effects of BIIB078 on clinical function. As the first-in-human study, the study enrolls a small number of participants in each cohort. Every participant in a cohort is treated with the same dose or placebo. The study is designed to evaluate and confirm the safety of each dose before enrolling and exposing new participants to a higher dose in the next cohort.
Primary Outcome
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death, places participant at immediate risk of death, requires initial or prolonged inpatient hospitalization, results in persistent or significant disability/incapacity, results in congenital anomaly, is a medically important event.
Interventions
- DRUG Placebo
- DRUG BIIB078
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 106 participants |
| Start Date | 2018-09-10 |
| Est. Completion | 2021-11-17 |
| Phase | Phase 1 |
What the finished NCT03626012 record still lists
NCT03626012 is an interventional study that assigns participants to a tested intervention. The registered 106 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03626012 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03626012 about?
NCT03626012 is a clinical study titled "A Study to Assess the Safety, Tolerability, and Pharmacokinetics of BIIB078 in Adults With C9ORF72-Associated Amyotrophic Lateral Sclerosis". The primary objective of this study is to evaluate the safety and tolerability of BIIB078 in adults with C9ORF72-Amyotrophic Lateral Sclerosis (ALS). The secondary objectives of this study are to evaluate the pharmacokinetic profile of BIIB078 and to evaluate the effects of BIIB078 on clinical funct...
What is the current status of trial NCT03626012?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 106 participants. The study started on 2018-09-10. Estimated completion is 2021-11-17.
What interventions are being tested in trial NCT03626012?
The interventions under investigation include: Placebo (DRUG), BIIB078 (DRUG).
Who is sponsoring clinical trial NCT03626012?
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 NCT03626012's enrollment target sits among peer trials
106 531st of 2000 higher than 1,468 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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