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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02634346 | A Study of ALKS 3831 in Adults With Acute Exacerbation of Schizophrenia (the ENLIGHTEN-1 Study) | PHASE3 | COMPLETED | 403 | — | — | Dec 1, 2015 | Jun 7, 2017 | Jun 27, 2018 | 31 | United States, Bulgaria +2 |
This scale consists of symptom constructs (7 positive, 7 negative, 16 general psychopathology), each to be rated on a 7-point Likert-type scale of severity with 1 being absent to 7 being extreme. Minimum scores (best outcome) equals 30 (total scale); maximum scores (worst outcome) equals 210 (total scale). Change is calculated between the baseline visit and Week 4.
| Arm | Type | Description |
|---|---|---|
| ALKS 3831 | EXPERIMENTAL | Administered as a coated bilayer tablet |
| Olanzapine | ACTIVE_COMPARATOR | Administered as a coated bilayer tablet |
| Placebo | PLACEBO_COMPARATOR | Administered as a coated bilayer tablet |
| Name | Type | Description |
|---|---|---|
| ALK3831 | DRUG | Daily dosing |
| Olanzapine | DRUG | Daily dosing |
| Placebo | DRUG | Daily dosing |
Inclusion Criteria: * Has a body mass index (BMI) of 18.0 - 40.0 kg/m\^2 * Meets criteria for the diagnosis of schizophrenia * Resides in a stable living situation when not hospitalized * Is willing and able to provide government-issued identification * Additional criteria may apply Exclusion Crit...