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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04987229 | Long-term Safety Extension Study of OLZ/SAM in Pediatric Subjects | PHASE3 | ENROLLING BY_INVITATION | 236 | — | — | Oct 22, 2021 | Sep 1, 2027 | Jun 2, 2026 | 35 | United States, Argentina +3 |
| NCT04987658 | Phase 1 Study of OLZ/SAM in Pediatric Subjects With Bipolar I Disorder | PHASE1 | COMPLETED | 7 | — | — | Jul 22, 2021 | Aug 11, 2023 | Nov 22, 2023 | 2 | United States |
| Arm | Type | Description |
|---|---|---|
| All subjects | EXPERIMENTAL | All subjects will receive OLZ/SAM at a dose determined by the Investigator and based on the olanzapine dosing received in the antecedent study (ALKS 3831-A311 or ALKS 3831-A312 ENLIGHTEN-Youth) |
| Group 1 Olanzapine/ 5 mg Samidorphan | EXPERIMENTAL | Olanzapine will be gradually increased to a target dose of 10mg/samidorphan 5mg (Range: 5-20mg Olanzapine/samidorphan 5mg) |
| Group 2 Olanzapine/ 10mg Samidorphan | EXPERIMENTAL | Olanzapine will be gradually increased to a target dose of 10mg/samidorphan 10mg (Range: 5-20mg Olanzapine/samidorphan 10mg) |
| Name | Type | Description |
|---|---|---|
| OLZ/SAM | DRUG | Olanzapine and Samidorphan fixed dose coated tablet taken once daily |
Inclusion Criteria: * Subject has completed the treatment period in either the ALKS 3831-A311 or the ALKS 3831-A312 study within 10 days of enrolling into this extension study, or subject had terminated early from Study ALKS 3831-A312 due to the clinically significant weight gain criterion. * Subje...