TY - JOUR
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.
AU - Swerdlow, Russell
AU - Wang, Yunxia
AU - Statland, Jeffrey
AU - Dimachkie, Mazen M.
AU - Glenn, Melanie
AU - Pasnoor, Mamatha
AU - Walsh, Maureen
AU - Emmons, Kelley
AU - Johns, Kathryn
AU - Harness, Yolanda
AU - Herbelin, Laura
AU - Katz, Jonathan
AU - Miller, Robert G.
AU - Forshew, Dallas
AU - Engel, Marguerite
AU - Goyal, Namita
AU - Cash, Tiyonnoh
AU - Mathew, Veena
AU - Martin, Veronica
AU - Saperstein, David
AU - Levine, Todd
AU - Flynne, Lynn
AU - Karam, Chafic
AU - Dimtrov, Diana
AU - Elman, Lauren
AU - McCluskey, Leo
AU - Almasy, Kelly
AU - Kelley, Mary
AU - Fernandes, J. Americo M.
AU - Santella, Regina
N1 - Publisher Copyright:
© 2018 Wiley Periodicals, Inc.
PY - 2019/2
Y1 - 2019/2
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.
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U2 - 10.1002/mus.26335
DO - 10.1002/mus.26335
M3 - Article
C2 - 30192007
AN - SCOPUS:85057307266
SN - 0148-639X
VL - 59
SP - 201
EP - 207
JO - Muscle and Nerve
JF - Muscle and Nerve
IS - 2
ER -