Rasagiline for amyotrophic lateral sclerosis: A randomized, controlled trial. Issue 2 (26th November 2018)

• Record Type: Journal Article
• Authors: Statland, Jeffrey M.; Moore, Dan; Wang, Yunxia; Walsh, Maureen; Mozaffar, Tahseen; Elman, Lauren; Nations, Sharon P.; Mitsumoto, Hiroshi; Fernandes, J. Americo; Saperstein, David; Hayat, Ghazala; Herbelin, Laura; Karam, Chafic; Katz, Jonathan; Wilkins, Heather M.; Agbas, Abdulbaki; Swerdlow, Russell H.; Santella, Regina M.; Dimachkie, Mazen M.; Barohn, Richard J.
• Other Names: Barohn Richard J. investigator.; Swerdlow Russell investigator.; Wang Yunxia investigator.; Statland Jeffrey investigator.; Dimachkie Mazen M. investigator.; Glenn Melanie investigator.; Pasnoor Mamatha investigator.; Walsh Maureen investigator.; Emmons Kelley investigator.; Johns Kathryn investigator.; Harness Yolanda investigator.; Herbelin Laura investigator.; Katz Jonathan investigator.; Miller Robert G investigator.; Forshew Dallas investigator.; Engel Marguerite investigator.; Mozaffar Tahseen investigator.; Goyal Namita investigator.; Cash Tiyonnoh investigator.; Mathew Veena investigator.; Martin Veronica investigator.; Saperstein David investigator.; Levine Todd investigator.; Flynne Lynn investigator.; Karam Chafic investigator.; Dimtrov Diana investigator.; Elman Lauren investigator.; McCluskey Leo investigator.; Almasy Kelly investigator.; Kelley Mary investigator.; Fernandes J. Americo M. investigator.; Thaisetthawatkul Pariwat investigator.; Peterson Carolyn investigator.; Cowardin Cindy investigator.; Heires Peggy investigator.; Nations Sharon investigator.; Trivedi Jaya investigator.; Gorham Nina F. investigator.; Hopkins Steve investigator.; Hayat Ghazala investigator.; Brown Susan investigator.; Mitsumoto Hiroshi investigator.; Aziz‐Zaman Sonya investigator.; Hupf Jonathan investigator.; Armstrong Nicole investigator.; McHale Brittany investigator.; Wilkins Heather investigator.; Agbas Abdulbaki investigator.; Sage Jessica investigator.; Hall Sharice investigator.; Santella Regina investigator.; Gurvich Irina investigator.; Amato Anthony investigator.; Bedlack Richard investigator.; Jackson Carlayne investigator.; Cutter Gary investigator.; Wolfe Gil investigator.; Simpson Ericka investigator.;
• Is Part Of: Muscle & nerve. Volume 59:Issue 2(2019)
• Page Start: 201
• Page End: 207
• Publication Date: 2018-11-26
• Subjects: amyotrophic lateral sclerosis -- biomarker -- MAO‐B inhibitor -- motor neuron disease -- randomized -- controlled clinical trial -- rasagiline; Neuromuscular diseases -- Periodicals; Muscles -- Periodicals; Nerves -- Periodicals; 616.74
• DOI: 10.1002/mus.26335
• Languages: English
• ISSNs: 0148-639X

Abstract

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