Trials / Terminated
TerminatedNCT04288856
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)
An Extension Study to Assess the Long-Term Safety, Tolerability, Pharmacokinetics, and Effect on Disease Progression of BIIB078 Administered to Previously Treated Adults With C9ORF72-Associated Amyotrophic Lateral Sclerosis
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 75 (actual)
- Sponsor
- Biogen · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
This study is an extension study of NCT03626012.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BIIB078 | Administered as specified in the treatment arm. |
Timeline
- Start date
- 2020-04-28
- Primary completion
- 2022-05-03
- Completion
- 2022-05-03
- First posted
- 2020-02-28
- Last updated
- 2023-04-18
Locations
21 sites across 5 countries: United States, Canada, Netherlands, Switzerland, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04288856. Inclusion in this directory is not an endorsement.