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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03201757 | Study to Evaluate the Long-term Safety, Tolerability, and Durability of Treatment Effect of ALKS 3831 | PHASE3 | COMPLETED | 523 | — | — | Jun 15, 2017 | Sep 6, 2023 | Sep 26, 2024 | 85 | United States, Austria +11 |
| NCT03187769 | Study to Evaluate the Efficacy of ALKS 3831 on Body Weight in Young Adults Who Have Been Recently Diagnosed With Schizophrenia, Schizophreniform, or Bipolar I Disorder | PHASE3 | COMPLETED | 426 | — | — | Jun 8, 2017 | Jan 3, 2022 | Jan 19, 2023 | 57 | United States, Austria +10 |
| NCT02873208 | A Phase 3, Long-term Safety and Tolerability Study of ALKS 3831 in Adults With Schizophrenia | PHASE3 | COMPLETED | 266 | — | — | Aug 7, 2016 | Oct 17, 2019 | Jul 21, 2021 | 45 | United States, Puerto Rico |
| NCT02694328 | A Study of ALKS 3831 in Adults With Schizophrenia (The ENLIGHTEN-2 Study) | PHASE3 | COMPLETED | 561 | — | — | Mar 2, 2016 | Nov 7, 2018 | Feb 10, 2020 | 54 | United States, Puerto Rico |
| NCT02669758 | A Long-Term Safety and Tolerability Study of ALKS 3831 in Adults With Schizophrenia | PHASE3 | COMPLETED | 281 | — | — | Jan 20, 2016 | Jun 29, 2018 | Jul 26, 2019 | 31 | United States, Bulgaria +2 |
| NCT02804568 | A Phase 1 Safety Study in Adults With Schizophrenia | PHASE1 | COMPLETED | 42 | — | — | Jun 1, 2016 | Aug 1, 2016 | Sep 22, 2016 | 3 | United States |
The clinical global impression - severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis; 1 being normal, not ill at all and 7 being among the severally ill patients
The efficacy analyses were performed using the Final Analysis Set which is defined as all randomized subjects who received one dose of study drug and had at least 1 primary efficacy assessment after administration of study drug
Overall summary of treatment emergent adverse events during the treatment period
| Arm | Type | Description |
|---|---|---|
| ALKS 3831 | EXPERIMENTAL | Coated bilayer tablet |
| Olanzapine | ACTIVE_COMPARATOR | Coated bilayer tablet |
| Group 1 | EXPERIMENTAL | Olanzapine/samidorphan 10 mg/10 mg |
| Group 2 | EXPERIMENTAL | Olanzapine/samidorphan 20 mg/10 mg |
| Name | Type | Description |
|---|---|---|
| ALKS 3831 | DRUG | Olanzapine + samidorphan, daily oral dosing |
| Olanzapine | DRUG | Daily oral dosing |
Inclusion Criteria: * Willing and able to give informed consent/assent as per local requirements * Agrees to use an acceptable method of contraception during the study, and for 30 days after any study drug administration, unless surgically sterile or post-menopausal * Has the potential to benefit f...