Rasagiline for amyotrophic lateral sclerosis: A randomized, controlled trial
The Rasagiline Investigators of the Muscle Study Group and Western ALS Consortium
Neurology & Neurotherapeutics - NE Neuro Muscular Section
Neurology & Neurotherapeutics
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.
Muscle and Nerve
https://doi.org/10.1002/mus.26335
MAO-B inhibitor
motor neuron disease
randomized
rasagiline
10.1002/mus.26335
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rasagiline Medicine & Life Sciences 100%
Amyotrophic Lateral Sclerosis Medicine & Life Sciences 65%
Randomized Controlled Trials Medicine & Life Sciences 41%
Placebos Medicine & Life Sciences 28%
Monoamine Oxidase Inhibitors Medicine & Life Sciences 12%
Monoamine Oxidase Medicine & Life Sciences 11%
Vital Capacity Medicine & Life Sciences 11%
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, 02.2019, p. 201-207.
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;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.
@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.",
doi = "10.1002/mus.26335",
journal = "Muscle and Nerve",
T1 - Rasagiline for amyotrophic lateral sclerosis
T2 - A randomized, controlled trial
AU - The Rasagiline Investigators of the Muscle Study Group and Western ALS Consortium
AU - Statland, Jeffrey M.
AU - Moore, Dan
AU - Wang, Yunxia
AU - Walsh, Maureen
AU - Mozaffar, Tahseen
AU - Elman, Lauren
AU - Nations, Sharon P
AU - Mitsumoto, Hiroshi
AU - Fernandes, J. Americo
AU - Saperstein, David
AU - Hayat, Ghazala
AU - Herbelin, Laura
AU - Karam, Chafic
AU - Katz, Jonathan
AU - Wilkins, Heather M.
AU - Agbas, Abdulbaki
AU - Swerdlow, Russell H.
AU - Santella, Regina M.
AU - Dimachkie, Mazen M.
AU - Barohn, Richard J.
N1 - 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's Biomarkers Laboratory was supported by grant ES009089. Publisher Copyright: © 2018 Wiley Periodicals, Inc.
N2 - 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.
AB - 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.
KW - MAO-B inhibitor
KW - amyotrophic lateral sclerosis
KW - biomarker
KW - controlled clinical trial
KW - motor neuron disease
KW - randomized
KW - rasagiline
U2 - 10.1002/mus.26335
DO - 10.1002/mus.26335
JO - Muscle and Nerve
JF - Muscle and Nerve