Selegiline is ineffective in a collaborative double-blind, placebo-controlled trial for treatment of amyotrophic lateral sclerosis.
BACKGROUND
The cause of amyotrophic lateral sclerosis (ALS) is not known, and there is no effective treatment. Cell death may be caused by oxidative damage. Selegiline hydrochloride (Eldepryl) is a monoamine oxidase-B inhibitor with antioxidant properties.


OBJECTIVE
To determine if selegiline affects the clinical course of patients with ALS.


METHODS
Six-month, double-blind, placebo-controlled study of 133 patients with classical ALS and symptoms for less than 3 years. The primary end point to indicate effectiveness was the rate of change of the Appel ALS total score, an index of disease severity that incorporates strength and function in limbs, respiratory function, and bulbar function.


RESULTS
Of the 133 patients, 67 were randomized to receive selegiline and 66 to receive placebo. One hundred four patients (53 in the selegiline group and 51 in the placebo group) completed the 6-month trial. Both groups were comparable for baseline characteristics and mean Appel ALS total score (70.5 points for the selegiline group and 70.6 for the placebo group). There was no difference in the rate of progression as measured by the Appel ALS total score, showing an average increase of 22 points in 6 months. The monthly rate of change was 3.4 for the selegiline group and 3.5 for the placebo group. There was 1 adverse reaction: worsening depression. Seven patients died during the study (4 in the selegiline group and 3 in the placebo group).


CONCLUSIONS
Selegiline treatment had no significant effect on the rate of clinical progression or outcome of ALS.
Lange
D J
DJ
Department of Neurology, The Neurological Institute, Columbia-Presbyterian Medical Center, New York, NY 10032, USA.
Murphy
P L
PL
Diamond
B
B
Appel
V
V
Lai
E C
EC
Younger
D S
DS
Appel
S H
SH
D000284:Administration, Oral; D000690:Amyotrophic Lateral Sclerosis / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D008996:Monoamine Oxidase Inhibitors / Q000008:administration & dosage / Q000627:therapeutic use*; D012642:Selegiline / Q000008:administration & dosage / Q000627:therapeutic use*; D016896:Treatment Outcome
D008996:Monoamine Oxidase Inhibitors; D012642:Selegiline