@article{b5b67e6c9b984e1cbe669c327923fbf5,
title = "Rasagiline for amyotrophic lateral sclerosis: A randomized, controlled trial",
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.",
keywords = "MAO-B inhibitor, amyotrophic lateral sclerosis, biomarker, controlled clinical trial, motor neuron disease, randomized, rasagiline",
author = "{The Rasagiline Investigators of the Muscle Study Group and Western ALS Consortium} and Statland, {Jeffrey M.} and Dan Moore and Yunxia Wang and Maureen Walsh and Tahseen Mozaffar and Lauren Elman and Nations, {Sharon P} and Hiroshi Mitsumoto and Fernandes, {J. Americo} and David Saperstein and Ghazala Hayat and Laura Herbelin and Chafic Karam and Jonathan Katz and Wilkins, {Heather M.} and Abdulbaki Agbas and Swerdlow, {Russell H.} and Santella, {Regina M.} and Dimachkie, {Mazen M.} and Barohn, {Richard J.}",
note = "Funding Information: Abbreviations: ALS, amyotrophic lateral sclerosis; ALSFRS-R, ALS Functional Rating Scale—Revised; ALSQOL, ALS Quality of Life; ELISA, enzyme-linked immunosorbent assay; FTD, frontotemporal dementia; FVC, forced vital capacity; IsoP, isoprostane; LME, linear mixed effects; MAO-B, monoamine oxidase B; ORAC, oxygen radical antioxidant capacity; PRO-ACT, Pooled Resource Open-Access ALS Clinical Trials; RCT, randomized, controlled trial; SVC, slow vital capacity; TDP-43, TAR DNA-binding protein 43; WALS, Western ALS Study Group Key words: amyotrophic lateral sclerosis, biomarker, MAO-B inhibitor, motor neuron disease, randomized, controlled clinical trial, rasagiline Funding: U.S. Food and Drug Administration Orphan Products Division (RO1 FD003739 to H.M.W., R.H.S., and R.J.B.; P30 AG035982 to H.M.W. and R.H.S.); NCATS grant awarded to the University of Kansas Medical Center for Frontiers: The Heartland Institute for Clinical and Translational Research (CTSA grants UL1TR000001 and KL2TR000119 to J.M.S.); Columbia{\textquoteright}s Biomarkers Laboratory was supported by grant ES009089. Publisher Copyright: {\textcopyright} 2018 Wiley Periodicals, Inc.",
year = "2019",
month = feb,
doi = "10.1002/mus.26335",
language = "English (US)",
volume = "59",
pages = "201--207",
journal = "Muscle and Nerve",
issn = "0148-639X",
publisher = "John Wiley and Sons Inc.",
number = "2",
}