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Quick Info
Status
Currently Recruiting
Estimated Enrollment
183
Phase
3
Treatment Type
Single and Multiple Ascending Dose
Trial Type
Double Blind, Placebo Controlled
Sponsor
Primary Investigator
Global Biogen Clinical Trial Center
Contact Information
Locations
Australia, Other
Westmead Hospital, Westmead, Australia
Australia New South Wales Westmead Hospital, Westmead New South Wales, Australia
Belgium, Other
UZ Leuven, Leuven, 3000, Belgium
Canada, Ontario
Sunnybrook Health Sciences Centre, Toronto, ON, M4N 3M5, Canada
Canada, Quebec
Montreal Neurological Institute, Montreal, QC, H3A 2B4, Canada
France, Other
Hospitali Pitie-Salpetriere, Paris, 75013, France
Germany, Other
Universitaetsklinikum Ulm, Ulm, Baden Wuerttemberg, 89081, Germany
Italy, Other
ALS center Dept. of Neuroscience University of Turin, Torino, 10126, Italy
Japan, Other
Japan Toyko-To, Bunkyo-Ku , 113-8655, Japan
Research Site, Bunkyo-Ku, Tokyo-To, 113-8655, Japan
Research Site, Kagoshima City, Japan
Japan Kagoshima-Ken, Kagoshima City, 890-8520, Japan
Japan Toyko-To, Shinjuku-ku, 160-8582, Japan
Research Site, Shinjuku-ku, Tokyo-To, Japan
Japan Osaka-Fu, Suita Shi, 565-0871, Japan
United Kingdom, Other
Sheffield Institute for Translational Neuroscience, Sheffield, South Yorkshire, S10 2HQ, United Kingdom
Research Site, Sheffield, South Yorkshire, S10 2HQ, United Kingdom
United States, Arizona
Barrow Neurological Institute, Phoenix, AZ, 85013, United States
Contact: Aide Raya   602-406-8144   aide.raya@dignityhealth.org
United States, California
University of California San Diego Medical Center, La Jolla, CA, 92093, United States
Forbes Norris MDA/ALS Research Center, San Francisco, CA, 94115, United States
United States, Florida
Mayo Clinic Florida, Jacksonville, FL, 32224, United States
University of Miami School of Medicine, Miami , FL, United States
Bioclinica Research, Orlando, FL, 32806, United States
Bioclinica Research , Orlando, FL, 32806, United States
United States, Georgia
Emory University Hospital , Atlanta, GA, 30322, United States
United States, Maryland
Johns Hopkins University, Baltimore, MD, 21287, United States
United States, Massachusetts
Massachusetts General Hospital, Boston, MA, 02114, United States
United States, Michigan
Henry Ford Hospital , Detroit, MI, 48202, United States
United States, Minnesota
Mayo Clinic Rochester, Rochester, MN, 55905, United States
United States, Missouri
Washington University School of Medicine, St. Louis, MO, 63110, United States
United States, Nebraska
Neurology Associates, Lincoln , NE, 65806, United States
United States, New York
Columbia University Medical Center, New York, NY, 10032, United States
United States, Ohio
The Cleveland Clinic Foundation, Cleveland , OH, 44106, United States
United States, Oregon
Providence ALS Center, Portland , OR, 97213, United States
United States, Tennessee
Alliance for Multispecialty Research, Knoxville, TN, 37920, United States
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
Contact information updated.
6/15/2020
No significant updates.
5/22/2020
No significant updates.
5/14/2020
No significant updates.
3/5/2020
No significant updates.
2/28/2020
New recruitment sites added
2/7/2020
No significant update
1/21/2020
No significant updates
1/13/2020
No significant updates
1/7/2020
No significant updates
1/7/2020
No significant updates
1/7/2020
No significant updates
12/19/2019
Updated recruitment locations
12/13/2019
No significant updates
12/6/2019
No significant update
12/2/2019
Added multiple new location sites
11/19/2019
Updated location site
11/7/2019
Recruitment Status updated
9/6/2019
Updated Study Purpose/ Recruitment status updated. More cites are currently recruiting.
8/30/2019
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
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
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. Detailed Description:This is a 3-part study to examine the efficacy, safety, tolerability, PK and PD of BIIB067. Part A is the single ascending dose (SAD) component of the study, Part B is the multiple ascending dose (MAD) component of the study and Part C will be the fixed dose component of the study. Hence, the overall phase of development of the study is 1/2/3.
Collaborator(s)
News Articles and Summaries
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ALS Forum
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Trial Protocol as Published on Clinicaltrials.gov
NCT02623699 (First Published: 11/24/2015)