Journal
MUSCLE & NERVE
Volume 59, Issue 2, Pages 201-207Publisher
WILEY
DOI: 10.1002/mus.26335
Keywords
amyotrophic lateral sclerosis; biomarker; MAO-B inhibitor; motor neuron disease; randomized; controlled clinical trial; rasagiline
Categories
Funding
- U.S. Food and Drug Administration Orphan Products Division [RO1 FD003739, P30 AG035982]
- NCATS [UL1TR000001, KL2TR000119]
- [ES009089]
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Introduction: Rasagiline is a monoamine oxidase B (MAO-B) inhibitor with possible neuroprotective effects in patients with amyotrophic lateral sclerosis (ALS). Methods: We performed a randomized, double-blind, placebo-controlled trial of 80 ALS participants with enrichment of the placebo group with historical controls (n = 177) at 10 centers in the United States. Participants were randomized in a 3:1 ratio to 2 mg/day rasagiline or placebo. The primary outcome was average slope of decline on the ALS Functional Rating Scale-Revised (ALSFRS-R). Secondary measures included slow vital capacity, survival, mitochondrial and molecular biomarkers, and adverse-event reporting. Results: There was no difference in the average 12-month ALSFRS-R slope between rasagiline and the mixed placebo and historical control cohorts. Rasagiline did not show signs of drug-target engagement in urine and blood biomarkers. Rasagiline was well tolerated with no serious adverse events. Discussion: Rasagiline did not alter disease progression compared with controls over 12 months of treatment. Muscle Nerve 59:201-207, 2019
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