Quick Info
Status
Ongoing, But Not Recruiting
Estimated Enrollment
80
Phase
1
Treatment Type
Drug: BIIB078
Trial Type
Randomized, Sequential assignment, quadruple masking
Sponsor
Biogen
Primary Investigator
Medical Director, Biogen
Contact Information
Locations
Research Site, La Jolla, 92037
Jacksonville, 32224
Baltimore, 21287
Boston, 02114
Knoxville, 37920
Miami, 33136
Atlanta, 30322
Saint Louis, 63110
New York, 10032
Montreal, H3A 2B4
Palo Alto, 94304
Lincoln, 68506
Los Angeles , 90048
Netherlands, Utrecht
United Kingdom Research Site, London
Research site, Sheffield
Enrollment Criteria
Breathing Ability
Percent lung function (FVC) or (SVC)
(SVC) ≥ 50%
Months Since Onset
Number of months since first symptoms of ALS.
not specified
Non-Invasive Ventilation (NIV)
Can PALS use a BiPAP in the trial?
no
Diaphragm Pacer (DPS)
Can PALS use a DPS in the trial?
no
Edaravone Usage
Can a PALS use edaravone (Radicut/Radicava) while enrolled in the trial?
Yes
Update Notes
No significant updates
12/2/2019
Locations added
10/25/2019
Updated anticipated trial completion date
10/4/2019
No significant updates
9/24/2019
Added New Site Location
9/12/2019
No significant updates
6/5/2019
Recruitment status updated
5/20/2019
Locations updated
3/20/2019
Locations updated
3/20/2019
Locations updated
3/4/2019
Locations and recruitment status updated
11/15/2018
Locations updated
10/26/2018
Recruitment status updated
9/17/2018
Trial added
8/20/2018

Other Information

Purpose
The primary objective of this study is to evaluate the safety and tolerability of BIIB078 in adults with C9ORF72-ALS. The secondary objective of this study is to evaluate the pharmacokinetic profile of BIIB078. As the first-in-human study, the study enrolls a small number of patients in each cohort. Every patient 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 patients to a higher dose in the next cohort. Therefore, proceeding from cohort to cohort, the recruitment status of "Active, not recruiting" may change. Please contact clinicaltrials@biogen.com for further information
Eligibility
18 Years and older, all genders. Not accepting healthy volunteers
Details
Collaborator(s)
    -
News Articles and Summaries
    -
ALS Forum
-
Trial Protocol as Published on Clinicaltrials.gov
NCT03626012 (First Published: 8/10/2018)
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