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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04101227 | Study to Evaluate AD04 in Adults With Alcohol Use Disorder (AUD) and Selected Serotonin Transporter Polymorphisms | PHASE3 | COMPLETED | 302 | — | — | Feb 1, 2020 | Mar 18, 2022 | Apr 17, 2024 | 25 | Bulgaria, Croatia +5 |
Change from baseline in the percentage of monthly HDDs, where (heavy) drinking is defined as the consumption of ≥ 60 g alcohol/day (if male) or ≥ 40 g alcohol/day (if female).
| Arm | Type | Description |
|---|---|---|
| Treatment Arm | EXPERIMENTAL | AD04 (ondansetron) |
| Placebo Arm | PLACEBO_COMPARATOR | Matching Placebo |
| Name | Type | Description |
|---|---|---|
| AD04 (ondansetron) | DRUG | AD04 (ondansetron) 0.33 mg, orally (p.o.) twice a day (BID) |
| Matching placebo | DRUG | Matching placebo to AD04 (ondansetron), orally (p.o.) twice a day (BID) |
| Companion Diagnostic for Genetic Testing | DEVICE | Companion Diagnostic for Genetic Testing |
| Brief Psychological Counseling | BEHAVIORAL | Brief Psychological Counseling |
Inclusion Criteria: 1. The subject has signed the Informed Consent Form. 2. The subject has breath alcohol concentration (BAC) of 0.00% at the Screening and \< 0.02 % at the Baseline visit. 3. The subject has moderate to severe diagnosis of AUD as measured by Diagnostic and Statistical Manual of Me...