Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Sabril, CPP 109, gamma vinyl GABA, GVG, VGB
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 being studied as a treatment for cocaine addiction and cocaine dependence. It is an investigational small molecule in Phase 2 clinical development, and it has not been approved for these uses. The research focuses on adults 18 years and older with cocaine dependence.
Vigabatrin targets ABAT, also known as gamma-aminobutyric acid transaminase. It acts as an inhibitor of this enzyme, which is involved in GABA metabolism. By inhibiting ABAT, vigabatrin raises GABA levels in the brain, a mechanism that researchers are studying in the context of cocaine dependence.
Catalyst Pharmaceuticals, Inc. (ticker: CPRX) is the developer of vigabatrin for cocaine addiction and cocaine dependence. The company is advancing the drug through Phase 2 clinical development in this psychiatry indication.
Vigabatrin is in Phase 2 clinical development for cocaine addiction and cocaine dependence. It is an investigational therapy and has not been approved by the FDA for these indications. The Phase 2 program includes completed trials, with no active trials currently listed.
Vigabatrin has been studied in Phase 2 trials for cocaine dependence, including NCT01281202, NCT00611130, and NCT00527683. These were randomized, double-blind, placebo-controlled studies conducted in the United States and Mexico, enrolling adults 18 years and older. All three trials are listed as completed.