Toxicity and tolerability of recombinant human ciliary neurotrophic factor in patients with amyotrophic lateral sclerosis.
We examined the toxicity of both single and multiple subcutaneous injections of recombinant human ciliary neurotrophic factor (rhCNTF) in 72 patients with ALS, in doses ranging from 2 to 100 micrograms/kg. Adverse events were generally dose related and ranged from mild to severe. The tolerability of daily subcutaneous rhCNTF was equivalent to placebo at doses < or = 5 micrograms/kg/day. At higher doses, anorexia, weight loss, reactivation of herpes simplex virus (HSV1) labialis/stomatitis, cough, and increased oral secretions occurred.
Miller
R G
RG
Department of Neurology, California Pacific Medical Center, San Francisco, USA.
Bryan
W W
WW
Dietz
M A
MA
Munsat
T L
TL
Petajan
J H
JH
Smith
S A
SA
Goodpasture
J C
JC
D000328:Adult; D000690:Amyotrophic Lateral Sclerosis / Q000188:drug therapy*; D020934:Ciliary Neurotrophic Factor; D004361:Drug Tolerance; D005260:Female; D006801:Humans; D008297:Male; D009414:Nerve Growth Factors / Q000009:adverse effects*; D009419:Nerve Tissue Proteins / Q000009:adverse effects*; D016037:Single-Blind Method
D020934:Ciliary Neurotrophic Factor; D009414:Nerve Growth Factors; D009419:Nerve Tissue Proteins