A PLACEBO-CONTROLLED TRIAL OF INSULIN-LIKE GROWTH-FACTOR-I IN AMYOTROPHIC-LATERAL-SCLEROSIS

To test the safety and efficacy of recombinant human insulin-like grow th 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 completio n, the primary efficacy outcome measure (change in disease progression as assessed by the Appel ALS rating scale) showed no significant diff erence between treatment groups. RhIGF-I appeared to be safe and well- tolerated.