Document Type

Article

Publication Title

Muscle & Nerve

Abstract

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.

DOI

10.1002/mus.26335

Publication Date

2-2019

Keywords

MAO-B inhibitor, amyotrophic lateral sclerosis, biomarker, controlled clinical trial, motor neuron disease, randomized, rasagiline

ISSN

1097-4598

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