The Phase II trial is designed as a randomized, double-blind, placebo-controlled, intent-to-treat, multicenter trial to evaluate the safety and efficacy of CPP-109 as a treatment for methamphetamine addiction.
The trial is expected to enroll 180 methamphetamine addicted patients at 15 addiction treatment clinical centers in the US. Patients will be treated for a period of 12 weeks, with an additional 12 weeks of follow-up.
The primary endpoint of the study is to demonstrate that a larger proportion of CPP-109-treated subjects than placebo-treated subjects will be methamphetamine-free during their last two weeks of treatment (weeks 11 and 12). Additionally, Catalyst will be measuring several secondary endpoints based on reduction in craving and of methamphetamine use.
Catalyst expects to immediately begin screening patients for inclusion in this trial and expects initial top-line results of the Phase II clinical trial to be available during summer 2009.