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NBI-1117568 · 6 trials · 3 indications
The PANSS evaluates the severity of various symptoms of schizophrenia, and is commonly used to measure symptom reduction in patients taking antipsychotics. Each item is scored on a 7-point severity scale (1=absent; 2=minimal; 3=mild; 4=moderate; 5=moderate severe; 6=severe; 7=extreme). The PANSS total score is derived from the summation of each item. A higher score indicates greater severity.
| Arm | Type | Description |
|---|---|---|
| NBI-1117568 | EXPERIMENTAL | All participants will receive NBI-1117568 during the Open-label Stabilization Period, then will be randomized to receive NBI-1117568 during the Double-blind Treatment Period. |
| Placebo | PLACEBO_COMPARATOR | All participants will receive NBI-1117568 during the Open-label Stabilization Period, then will be randomized to receive placebo matching NBI-1117568 during the Double-blind Treatment Period. |
| Dose Level A | EXPERIMENTAL | Participant administered Dose Level A (6 weeks) |
| Dose Level B | EXPERIMENTAL | Participant administered Dose Level B (6 weeks) |
| Dose Level C | EXPERIMENTAL | Participant administered Dose Level C (6 weeks) |
| Dose Level D | EXPERIMENTAL | Participant administered Dose Level D (6 weeks) |
| Placebo Schedule | PLACEBO_COMPARATOR | Participant administered placebo (6 weeks) |
| Name | Type | Description |
|---|---|---|
| NBI-1117568 | DRUG | Oral capsules |
| Placebo | DRUG | Oral capsules |
Key Inclusion Criteria: * Participant has a primary diagnosis of schizophrenia established by a comprehensive psychiatric evaluation based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria. * Participant had the initial diagnosis of schiz...