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From the Department of Neurology (Dr. Borasio), University of Munich, Germany; the Department of Neurology (Dr. Robberecht), University of Leuven, Belgium; the Department of Clinical Neurosciences (Dr, Leigh), Institute of Psychiatry and King's College School of Medicine and Dentistry, London, UK; the Laboratory of Experimental Neurology (Dr. Vos). Academic Medical Center, Amsterdam, the Netherlands; the Department of Neurology B (Dr. Emile), University Medical Center, Angers, France; the Department of Neurology (Dr. Jerusalem), University of Bonn, Germany; The Neuromuscular Unit (Dr. Guiloff), Charing Cross Hospital, London, UK; the Department of Neurology (Dr. Silani), I.R.C.C.S. Ospedale Maggiore, University of Milan, Italy; the Division of Neuromuscular Diseases (Drs. Vos and Wokke), University of Utrecht, the Netherlands; and Cephalon, Inc. (Dr. Dobbins), West Chester, PA.
Address correspondence and reprint requests to Dr. Gian Domenico Boraiso, Department of Neurology, University of Munich, Klinikum Grosshadern, D-81366 München, Germany.
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.
Supported by Cephalon, Inc., and Chiron, Inc. The investigators received no financial incentives such as equity interest, patent rights, or corporate affiliation. Compensation was provided only for the cost of the study and for partial reimbursement of investigator time in carrying out the trial.
Deceased.
See the appendix for a list of the participants and their institutions.
Presented in part at the 6th International Symposium of ALS/MND, Dublin, Ireland, November 1995.
Received September 9, 1997. Accepted in final form March 10, 1998.
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