The Phase II trial is designed as a randomized, double-blind, placebo- controlled, intent-to-treat, multi-center study to evaluate the safety and efficacy of CPP-109 as a treatment for cocaine addiction. Under the study protocol, patients will be treated for a period of 12 weeks, with an additional 12 weeks of follow-up.
The primary objective of the study is to demonstrate that a larger proportion of CPP-109-treated subjects than placebo- treated subjects are cocaine-free during their last two weeks of treatment (weeks 11 and 12). Additionally, Catalyst will be measuring a number of secondary endpoints based on reductions of cocaine use and craving. CPP-109, an orally administered, small molecule drug which inhibits psychostimulant-induced dopamine release, is Catalyst’s lead compound, vigabatrin.
Patrick McEnany, CEO of Catalyst, said: “We expect to add more clinical trial sites to the 10 previously disclosed in order to complete the trial as soon as possible. We anticipate initial top-line results from this trial to be available by year-end.”