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Quick Info
Status
Enrolling by invitation
Estimated Enrollment
183
Phase
3
Treatment Type
Drug: BIIB067
Trial Type
Non-Randomized, Parallel Assignment, No masking
Sponsor
Primary Investigator
Medical Director, Biogen
Contact Information
Locations
Belgium, Other
Research Site, Leuven, 3000, Belgium
Canada, Ontario
Research Site, Toronto, ON, M4N 3M5, Canada
Canada, Quebec
Research Site, Montreal, QC, H3A2B4, Canada
Canada,
Research Site, Calgery- Alberta, T2N426, Canada
France, Other
Research Site, 63003, France
Germany, Other
Research Site, Ulm, 89081, Germany
Japan, Other
Research Site, Bunkyo-Ku, Japan
Research Site, Kagoshima- Shi, Japan
Research Site, Shin Juku, Japan
Research Site, Suita-Shi, Japan
United Kingdom, Other
Research Site, Sheffield, S102HQ, United Kingdom
United States, Arizona
Research Site, Phoenix, AZ, 85013, United States
United States, California
Research Site, La Jolla, CA, 92093-0949, United States
Research Site, San Francisco, CA, 94115, United States
United States, Florida
Research Site, Jacksonville, FL, 32224, United States
Research Site, Orlando, FL, 32806, United States
United States, Georgia
Research Site, Atlanta, GA, 30322, United States
United States, Maryland
Research Site, Baltimore, MD, 21287, United States
United States, Massachusetts
Research Site, Boston, MA, 02114, United States
United States, Minnesota
Research Site, Rochester, MN, 55095, United States
United States, Missouri
Research Site, St. Louis, MO, 63110, United States
United States, Nebraska
Research Site, Lincoln, NE, 68510, United States
United States, Oregon
Research Site, Portland, OR, 97213, United States
United States, Tennessee
Research Site, Knoxville, TN, 37920, United States
Enrollment Criteria
Breathing Ability
Percent lung function (FVC) or (SVC)
Not specified
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?
Not specified
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
No significant update.
6/15/2020
More research sites added.
6/4/2020
Enrolling by invitation.
3/27/2020
No Significant Updates
12/19/2019
No significant updates.
7/24/2019
Location, protocol, and enrollment criteria updated.
3/27/2019
No significant updates
8/13/2018
No significant updates
4/9/2018
No significant updates
1/10/2018
No significant updates
10/16/2017
No significant updates
7/17/2017
Contact info updated
5/23/2017
Enrolling by invitation
4/18/2017
Enrolling by invitation
4/18/2017
Locations updated
4/18/2017
Trial Added
3/6/2017

Other Information

Purpose
The primary objective of the study is to evaluate the long-term safety and tolerability of BIIB067 in participants with amyotrophic lateral sclerosis (ALS) and confirmed superoxide dismutase 1 (SOD1) mutation. The secondary objectives are to evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) profiles and effects on disease progression of BIIB067 administered to participants with ALS and confirmed SOD1 mutation.
Eligibility
18 years +, all genders, Not accepting healthy volunteers
Details
Collaborator(s)
News Articles and Summaries
    -
ALS Forum
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Trial Protocol as Published on Clinicaltrials.gov
NCT03070119 (First Published: 2/28/2017)