Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01281202 | Vigabatrin for the Treatment of Cocaine Dependency | PHASE2 | COMPLETED | 207 | — | — | Jan 1, 2011 | Dec 1, 2012 | May 18, 2016 | 13 | United States |
The number of subjects in each treatment group who are cocaine abstinent during the last 2 weeks of the Treatment Phase (Weeks 8 and 9).
| Arm | Type | Description |
|---|---|---|
| CPP-109 Vigabatrin Tablets | ACTIVE_COMPARATOR | Subjects were evaluated for their compliance with protocol inclusion/exclusion criteria during a -2 to -4 week Screening/Baseline Phase During treatment, subjects received 3 CPP-109 Vigabatrin 500 mg Tablets, bid, for 9 weeks Subjects were provided with on-site, supervised, standardized, manualized Individual Drug Counseling 1x per week for 9 weeks and the first 4 weeks for the follow-up phase (weeks 10-13) |
| Placebo | PLACEBO_COMPARATOR | Subjects were evaluated for their compliance with protocol inclusion/exclusion criteria during a -2 to -4 week Screening/Baseline Phase During treatment, subjects received Vigabatrin matching placebo tablets, bid, for 9 weeks Subjects were provided with on-site, supervised, standardized, manualized Indivdiual Drug Counseling 1x per week for 9 weeks and the first 4 weeks for the follow-up phase (weeks 10-13) |
| Name | Type | Description |
|---|---|---|
| Vigabatrin | DRUG | Tablets |
| Matching Placebo | DRUG | Tablets |
Inclusion Criteria: * Able to understand the study and provide written informed consent. * Male or female at least 18 years of age. * Meet DSM-IV criteria for cocaine dependence as primary diagnosis, as determined by the Substance Abuse Structured Clinical Interview (SCID) for Diagnostic and Statis...