Quick Info
Status
Currently Recruiting
Estimated Enrollment
84
Phase
1
Treatment Type
Single and Multiple Ascending Dose
Trial Type
Double Blind, Placebo Controlled
Sponsor
Primary Investigator
Medical Director, Biogen
Contact Information
Locations
Barrow Neurological Institute, Phoenix, 85013
University of California San Diego Medical Center, La Jolla, 92093
Forbes Norris MDA/ALS Research Center, San Francisco, 94115
Bioclinica Research, Orlando, 32806
The Emory Clinic, Atlanta, 30322
Johns Hopkins Hospital, Baltimore, 21287
Massachusetts General Hospital, MA, Boston, 02114
Washington University School of Medicine, St. Louis, 63110
Alliance for Multispecialty Research, Knoxville, 37920
UZ Leuven, Leuven, 3000
Sunnybrook Health Sciences Centre, Toronto, M4N 3M5
Montreal Neurological Institute, Montreal, H3A 2B4
Hospitalier Pitie-Salpetriere, Paris, 75013
Universitaetsklinikum Ulm, Ulm, Baden Wuerttemberg, 89081
Norrlands universitetssjukhus, Umeå, 90185
Sheffield Institute for Translational Neuroscience, Sheffield, South Yorkshire, S10 2HQ
Research Site, Shinjuku-ku, Tokyo-To
Research Site, Kagoshima City
Research Site, Sheffield, South Yorkshire, S10 2HQ
Research Site, Bunkyo-Ku, Tokyo-To, 113-8655
Enrollment Criteria
Breathing Ability
Percent lung function (FVC) or (SVC)
≥50%
Months Since Onset
Number of months since first symptoms of ALS.
n/a
Non-Invasive Ventilation (NIV)
Can PALS use a BiPAP in the trial?
Maybe
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?
Unknown
Update Notes
Location added.
8/20/2019
Locations updated.
8/2/2019
No significant updates.
7/8/2019
No significant updates
7/1/2019
Recruitment status at locations updated
6/10/2019
No significant updates
5/31/2019
Location recruitment status updated
5/24/2019
Location recruitment status updated
5/6/2019
Location recruitment status updated
4/29/2019
Location recruitment status updated
4/22/2019
Location recruitment status updated
4/16/2019
Location recruitment status updated
4/8/2019
Location recruitment status updated
3/20/2019
Recruitment status updated
3/11/2019
Recruitment status updated
9/3/2018
No significant updates
5/31/2018
No significant updates
4/20/2018
No significant updates
3/16/2018
Recruitment status updated
2/15/2018
No significant updates
1/19/2018
No significant updates
12/5/2017
No significant updates
11/13/2017
No significant updates
10/5/2017
Recruitment status at location updated
9/15/2017
No significant updates
8/18/2017
No significant updates
7/12/2017
No significant updates
6/16/2017
No significant updates
5/1/2017
No significant updates
3/29/2017
Recruitment status updated
3/6/2017
No significant updates
3/6/2017
No significant changes
10/12/2016
Recruitment status updated
9/9/2016
Recruitment status updated
8/18/2016
Recruitment status updated
7/12/2016
No Significant Updates
6/8/2016
Sponsor/Collaborator updated.
4/11/2016
Recruitment status updated.
2/3/2016
Clinical trial added.
12/11/2015

Other Information

Purpose
The primary objective of Parts A and B of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of BIIB067 in adult with ALS. The primary objective of Part C of this study is to evaluate the clinical efficacy of BIIB067 administered to adult participants with ALS and confirmed superoxide dismutase 1 (SOD1) mutation. The secondary objective of Parts A and B of this study is to evaluate the effects of BIIB067 on levels of SOD1 protein in the cerebrospinal fluid (CSF). The secondary objectives of Part C are to evaluate the safety, tolerability, and pharmacodynamic (PD) effects of BIIB067 administered to adult participants with ALS and confirmed SOD1 mutation.
Eligibility
18 years or older, all genders, no healthy volunteers. Possible, probable, or definite ALS. It is not a requirement to have an SOD1 mutation to enroll in this study.
Details
Collaborator(s)
News Articles and Summaries
    -
ALS Forum
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Trial Protocol as Published on Clinicaltrials.gov
NCT02623699 (First Published: 11/24/2015)