Catalyst
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Cerecor Announces Initiation of Phase 2 Clinical Trial With CERC-501 for Smoking Cessation; top-line data expected in December 2016
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Additional Information
This is a thirty-day, double-blind, placebo-controlled, crossover study in subjects who are heavy cigarette smokers and currently not seeking treatment for tobacco use disorder. “We are enthusiastic about the potential use of CERC-501 for smoking cessation as well as other addictive disorders,” said Ronald Marcus, M.D., Chief Medical Officer and Head of Regulatory Affairs at Cerecor. The trial design assumes enrollment of 66 subjects who are heavy smokers. In Period 1, half the subjects in each group will receive CERC-501 and the other half will receive placebo. Each subject will then “crossover” to the opposite treatment during Period 2 after a wash-out period. The crossover design allows for subjects to be their own control. The primary objective of the study is to evaluate the effect of CERC-501 compared to placebo on symptoms of tobacco withdrawal and smoking behaviors in subjects who are not seeking treatment for tobacco use disorder. The Company expects to have top-line data in the second half of 2016.
Top-Line Phase 2 Data Expected in December 2016
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Catalyst Date
Occurred on:
Dec 05, 2016
Occurred Source:
http://ir.cerecor.com/press-releases/detail/31/cerecor-announces-top-line-results-from-cerc-501-phase-2
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Related Keywords
Phase 2 Clinical Trial, Cerc-501, Smoking Cessation, Heavy Cigarette Smokers, Tobacco Withdrawal, Tobacco Use Disorder
