Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Vigabatrin · 3 trials · 2 indications
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).
Number of subjects in the CPP-109 Vigabatrin Group vs. Number in Placebo Group abstinent from using cocaine during Weeks 11 and 12 of the Treatment Phase.
| Arm | Type | Description |
|---|---|---|
| A | ACTIVE_COMPARATOR | Subjects will receive vigabatrin in escalating doses to 3 grams per day over three weeks, continued for 4 weeks and then tapered to zero over the next 2 weeks. |
| B | PLACEBO_COMPARATOR | Orange juice and administration identical to Arm A. |
| 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) |
| 1 | EXPERIMENTAL | 3 Vigabatrin Tablets, 500 mg, bid, for 9 weeks |
| 2 | PLACEBO_COMPARATOR | 3 Placebo Tablets, bid, for 9 weeks |
| Name | Type | Description |
|---|---|---|
| Vigabatrin | DRUG | crystalline drug dissolved in orange juice, dosage escalates from 500 mg twice daily to 1.5 g twice daily over a 3 week period. This dose is maintained for 4 weeks and then tapered to zero over the next two weeks |
| Placebo | DRUG | orange juice is administered twice daily in containers indistinguishable from the treatment arm. |
| Group therapy | BEHAVIORAL | Participants attend group sessions once a week |
| Matching Placebo | DRUG | Tablets |
Inclusion Criteria: In order to participate in the study, subjects must * Be at least 18 years of age and no older than 55 years of age. * Weigh more than 100 pounds. * Have a DSM-IV diagnosis of cocaine dependence. * Be seeking treatment for cocaine dependence. * Have a urine sample positive for ...
Vigabatrin is an investigational small molecule being studied for the treatment of cocaine dependence and cocaine addiction. It is in Phase 2 clinical development for these psychiatric conditions. Vigabatrin has been evaluated in completed clinical trials enrolling adults aged 18 years and older.
Catalyst Pharmaceuticals, Inc. (CPRX) is developing Vigabatrin for cocaine dependence and cocaine addiction. The company is conducting clinical research to evaluate the drug's safety and efficacy in this psychiatric indication.
Vigabatrin is in Phase 2 clinical development for cocaine dependence and cocaine addiction. It is an investigational drug and has not been approved for this use. Clinical trials have been completed to assess its effects in patients with these conditions.
Vigabatrin has been studied in three completed Phase 2 clinical trials for cocaine dependence. These include NCT00527683 in Mexico with 100 participants, NCT00611130 in the United States with 186 participants, and NCT01281202 in the United States with 207 participants. All trials were randomized, double-blind, and placebo-controlled.
Vigabatrin is the same drug that is approved for epilepsy, but it is being investigated for a new use in cocaine dependence and cocaine addiction. In this context, it is an investigational drug in Phase 2 development by Catalyst Pharmaceuticals, Inc. for the psychiatric indication.