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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01887366 | Efficacy and Safety of TV-1380 as Treatment for Facilitation of Abstinence in Cocaine-Dependent Subjects | PHASE2 | COMPLETED | 208 | — | — | Jun 1, 2013 | Oct 1, 2014 | Nov 5, 2015 | 19 | United States, Spain |
| Arm | Type | Description |
|---|---|---|
| TV-1380 150 mg | EXPERIMENTAL | - |
| TV-1380 300 mg | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| TV-1380 150 mg | DRUG | Subjects assigned to TV-1380 150 mg will be administered one intra-muscular (IM) injection once weekly over 12 weeks. The injection volume will be the same for all treatment groups. Therefore, to accommodate the volume required for the highest dosing group (3.0 mL), subjects in this group will receive 3.0 mL IM injection of TV-1380 150 mg (1.5 mL TV-1380 and 1.5 mL placebo/diluents). |
| TV-1380 300 mg | DRUG | Subjects assigned to TV-1380 300 mg will be administered one intra-muscular (IM) injection once weekly over 12 weeks. Subjects in this treatment group will receive 3.0 mL TV-1380. |
| Placebo | DRUG | Subjects assigned to placebo will be administered one intra-muscular (IM) injection once weekly over 12 weeks. Subjects in this treatment group will receive 3.0 mL placebo. |
Inclusion Criteria: * Have the ability to understand, and having understood, provide written informed consent to comply with the treatment protocol. * Male or female aged 18-60 years (inclusive). * Meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition. * Other criteria apply; p...