A placebo-controlled trial of insulin-like growth factor-I in amyotrophic lateral sclerosis. European ALS/IGF-I Study Group.
To test the safety and efficacy of recombinant human insulin-like growth factor-I (rhIGF-I) in ALS, 183 patients from eight European centers were randomized to receive double-blind placebo (n = 59) or rhIGF-I 0.1 mg/kg/day (n = 124) subcutaneously for 9 months. At study completion, the primary efficacy outcome measure (change in disease progression as assessed by the Appel ALS rating scale) showed no significant difference between treatment groups. RhIGF-I appeared to be safe and well-tolerated.
Borasio
G D
GD
Department of Neurology, University of Munich, Germany.
Robberecht
W
W
Leigh
P N
PN
Emile
J
J
Guiloff
R J
RJ
Jerusalem
F
F
Silani
V
V
Vos
P E
PE
Wokke
J H
JH
Dobbins
T
T
D000328:Adult; D000690:Amyotrophic Lateral Sclerosis / Q000188:drug therapy*; D004311:Double-Blind Method; D005060:Europe; D006801:Humans; D007334:Insulin-Like Growth Factor I / Q000627:therapeutic use*; D011994:Recombinant Proteins / Q000627:therapeutic use
D011994:Recombinant Proteins; D007334:Insulin-Like Growth Factor I