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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05658510 | Dexmedetomidine in the Treatment of Agitation Associated With Schizophrenia and Bipolar Disorder (SERENITY III) | PHASE3 | COMPLETED | 452 | — | — | Nov 21, 2022 | Aug 15, 2025 | Sep 18, 2025 | 24 | United States |
The Positive and Negative Syndrome Scale - Excited Component (PEC) comprises 5 items associated with agitation: poor impulse control, tension, hostility, uncooperativeness, and excitement; each scored 1 (minimum) to 7 (maximum). The PEC, the sum of these 5 subscales, thus ranges from 5 (absence of agitation) to 35 (extremely severe)
To assess the safety of 120 mcg BXCL501 when used in an at-home environment based on serious adverse events (SAE) and treatment emergent adverse events (TEAEs).
| Arm | Type | Description |
|---|---|---|
| Part 1: 60 mcg of BXCL501 | EXPERIMENTAL | Sublingual film containing 60 Micrograms Dexmedetomidine |
| Part 1: Matching Placebo | PLACEBO_COMPARATOR | Sublingual Placebo film |
| Part 2: 120 mcg of BXCL501 | EXPERIMENTAL | Sublingual film containing 120 Micrograms Dexmedetomidine |
| Part 2: Matching Placebo | PLACEBO_COMPARATOR | Sublingual Placebo film |
| Name | Type | Description |
|---|---|---|
| BXCL501 | DRUG | Sublingual Film |
| Matching Placebo | DRUG | Sublingual Placebo Film |
A patient may enroll in only one part of the study; either Part 1 or Part 2. Inclusion Criteria: * Male and female patients between the ages of 18 to 75 years, inclusive * Patients who can read, understand and provide written informed consent. * Patients who have met Diagnostic and Statistical Man...