A pilot, double-blind, placebo-controlled trial of indinavir in patients with ALS.
There is some evidence of retroviral infection in ALS. A randomized, double-blind, placebo-controlled trial of indinavir in ALS was performed to assess safety and efficacy trends. Nephrolithiasis and gastrointestinal side effects were frequent with indinavir treatment. Group differences in the rate of decline were not significant between the groups for the ALS Functional Rating Scale (p = 0.36) or for the secondary variables. The toxicity and negative efficacy trends discourage further indinavir trials in ALS.
Scelsa
S N
SN
Beth Israel Medical Center, New York, NY, USA. sscelsa@bethisraelny.org.
MacGowan
D J L
DJ
Mitsumoto
H
H
Imperato
T
T
LeValley
A J
AJ
Liu
M H
MH
DelBene
M
M
Kim
M Y
MY
D000690:Amyotrophic Lateral Sclerosis / Q000188:drug therapy* / Q000503:physiopathology / Q000821:virology; D002490:Central Nervous System / Q000187:drug effects* / Q000503:physiopathology / Q000821:virology; D004311:Double-Blind Method; D005260:Female; D017320:HIV Protease Inhibitors / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D019469:Indinavir / Q000008:administration & dosage* / Q000009:adverse effects*; D007669:Kidney Calculi / Q000139:chemically induced; D008297:Male; D008875:Middle Aged; D018696:Neuroprotective Agents / Q000008:administration & dosage / Q000009:adverse effects; D010865:Pilot Projects; D010919:Placebos; D019782:Riluzole / Q000008:administration & dosage / Q000009:adverse effects; D017211:Treatment Failure
D017320:HIV Protease Inhibitors; D018696:Neuroprotective Agents; D010919:Placebos; D019469:Indinavir; D019782:Riluzole