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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00804570 | A Study for the Treatment of Alcohol Dependence | PHASE2 | COMPLETED | 375 | — | — | Nov 1, 2008 | Feb 1, 2010 | Sep 24, 2019 | 17 | United States |
The Timeline Followback Method assesses the subject's daily drinking by means of a calendar that covers a specific time period and was used to assess the number of heavy drinking days. Heavy drinking is defined as ≥4 drinks/day for women and ≥5 drinks/day for men. Least Squares (LS) Mean value was controlled for treatment, pooled investigator, visit, gender, family history, treatment\*visit, gender\*family history, baseline, and baseline\*visit. An unstructured covariance structure was used.
| Arm | Type | Description |
|---|---|---|
| LY2196044 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| LY2196044 | DRUG | 250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks |
| placebo | DRUG | once daily, orally, 16 weeks |
Inclusion Criteria: * Have Alcohol Dependence. Subjects must manifest at least the following 3 requirements for their diagnosis of Alcohol Dependence: 1. Be tolerant, as defined by either of the following: 1. A need for markedly increased amounts of alcohol to achieve intoxication or desir...