Quick Info
Status
This study has been completed
Estimated Enrollment
80
Phase
2
Treatment Type
Oral tablet
Trial Type
Randomized double-blind placebo-controlled
Primary Investigator
Richard Barohn, MD
Contact Information
Locations
UT Southwestern Medical Center, Dallas, 75235
University of Pennsylvania, Philadelphia, 19107
University of California - Irvine, Irvine, 92697
University of Kansas Medical Center, Kansas City, 66160
Columbia University, New York, 10032
University of Nebraska, Omaha, 68182
Phoenix Neurological Associates, Phoenix, 85018
Oregon Health and Science University, Portland, 97239
California Pacific Medical Center, San Francisco, 94117
St. Louis University, St Louis, 63103
Enrollment Criteria
Breathing Ability
Percent lung function (FVC) or (SVC)
≥75% (VC)
Months Since Onset
Number of months since first symptoms of ALS.
<24
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?
Unknown
Update Notes
Study complete
1/28/2020
Sponsor updated
6/16/2017
No significant updates
1/24/2017
No significant updates
11/9/2016
No significant updates.
5/3/2016
Recruitment status updated.
11/30/2015
Protocol Updated.
8/7/2015
No significant updates.
6/1/2015
Recruitment status updated.
2/17/2015
Description updated.
5/5/2014
Recruitment location updated.
2/28/2014
Recruitment status update.
2/28/2014
Recruiting status updated
1/24/2014
New trial added.
1/9/2014

Other Information

Purpose
By doing this study, researchers hope to learn if rasagiline is safe and slows disease progression in patients with ALS.
Eligibility
People 21-80 yrs of age with laboratory-supported probable, probable, or definite ALS. No healthy volunteers.
Details
Participants will take 2mg rasagiline daily for 12 months or placebo for 12 months and then 2mg rasagiline for 12 months. Primary outcome is ALS-FRS. Secondary outcomes include changes in vital capacity and quality of life.
Collaborator(s)
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News Articles and Summaries
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ALS Forum
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Trial Protocol as Published on Clinicaltrials.gov
NCT01786603 (First Published: 11/28/2013)