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document
A phase I study of recombinant human ciliary neurotrophic factor ( rHCNTF ) in patients with amyotrophic lateral sclerosis . The ALS CNTF Treatment Study ( ACTS ) Phase I-II Study Group . Fifty-seven patients with amyotrophic lateral sclerosis ( ALS ) were randomly assigned to receive 0.5 , 1 , 3 , 7 , 10 , or 30 micrograms/kg recombinant human ciliary neurotrophic factor ( rHCNTF ) or placebo subcutaneously 3 times a week for 2 weeks . Dose-limiting toxicity , consisting of febrile reactions in some patients , fatigue , and nonproductive cough , was observed at a dose level of 30 micrograms/kg . Dose-related changes in parameters of the acute-phase response were noted , consistent with the relationship of CNTF and its receptor system to the cytokine interleukin-6 ( IL-6 ) and its receptor . No adverse neurologic consequences of rHCNTF administration were observed . Antibodies to rHCNTF were observed in sera of most patients tested after 2 weeks of continuous treatment and 4 weeks ' withdrawal period . rHCNTF was safe and tolerated within acceptable limits when administered to patients with ALS in this study at doses of up to 30 micrograms/kg 3 times a week for 2 weeks . Further studies to explore the efficacy of rHCNTF in the treatment of human motor neuron diseases are justified .
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Intervention_Pharmacological
recombinant human ciliary neurotrophic factor ( rHCNTF )
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Intervention_Pharmacological
recombinant human ciliary neurotrophic factor ( rHCNTF )
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Intervention_Control
placebo
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Intervention_Pharmacological
CNTF
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Intervention_Pharmacological
rHCNTF
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Intervention_Pharmacological
rHCNTF
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Intervention_Pharmacological
rHCNTF
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Intervention_Pharmacological
rHCNTF
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Outcome_Physical
Dose-limiting toxicity
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Outcome_Physical
consisting of febrile reactions in some patients
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Outcome_Physical
fatigue
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Outcome_Physical
nonproductive cough
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Outcome_Physical
Dose-related changes in parameters of the acute-phase response
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Outcome_Adverse-effects
adverse neurologic consequences of rHCNTF administration
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Outcome_Physical
Antibodies to rHCNTF
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Outcome_Other
safe and tolerated
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Participant_Condition
amyotrophic lateral sclerosis
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Participant_Sample-size
Fifty-seven
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Participant_Condition
amyotrophic lateral sclerosis ( ALS )
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Participant_Condition
ALS