Rasagiline for amyotrophic lateral sclerosis: A randomized, controlled trial

The Rasagiline Investigators of the Muscle Study Group and Western ALS Consortium

Research output: Contribution to journalArticle

3 Citations (Scopus)

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. Muscle Nerve 59:201–207, 2019.

Original languageEnglish (US)
Pages (from-to)201-207
Number of pages7
JournalMuscle and Nerve
Volume59
Issue number2
DOIs
StatePublished - Feb 1 2019

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Amyotrophic Lateral Sclerosis
Randomized Controlled Trials
Placebos
Biomarkers
Monoamine Oxidase Inhibitors
Monoamine Oxidase
Vital Capacity
Neuroprotective Agents
Disease Progression
rasagiline
Urine
Muscles
Survival
Pharmaceutical Preparations

Keywords

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

ASJC Scopus subject areas

  • Physiology
  • Clinical Neurology
  • Cellular and Molecular Neuroscience
  • Physiology (medical)

Cite this

The Rasagiline Investigators of the Muscle Study Group and Western ALS Consortium (2019). Rasagiline for amyotrophic lateral sclerosis: A randomized, controlled trial. Muscle and Nerve, 59(2), 201-207. https://doi.org/10.1002/mus.26335

Rasagiline for amyotrophic lateral sclerosis : A randomized, controlled trial. / The Rasagiline Investigators of the Muscle Study Group and Western ALS Consortium.

In: Muscle and Nerve, Vol. 59, No. 2, 01.02.2019, p. 201-207.

Research output: Contribution to journalArticle

The Rasagiline Investigators of the Muscle Study Group and Western ALS Consortium 2019, 'Rasagiline for amyotrophic lateral sclerosis: A randomized, controlled trial', Muscle and Nerve, vol. 59, no. 2, pp. 201-207. https://doi.org/10.1002/mus.26335
The Rasagiline Investigators of the Muscle Study Group and Western ALS Consortium. Rasagiline for amyotrophic lateral sclerosis: A randomized, controlled trial. Muscle and Nerve. 2019 Feb 1;59(2):201-207. https://doi.org/10.1002/mus.26335
The Rasagiline Investigators of the Muscle Study Group and Western ALS Consortium. / Rasagiline for amyotrophic lateral sclerosis : A randomized, controlled trial. In: Muscle and Nerve. 2019 ; Vol. 59, No. 2. pp. 201-207.
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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. Muscle Nerve 59:201–207, 2019.",
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