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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05025605 | Determining Efficacy and Safety of BXCL501 in Agitation Associated With Pediatric Schizophrenia and Bipolar Disorder | PHASE1 | RECRUITING | 140 | — | — | Aug 27, 2021 | Dec 31, 2027 | Apr 13, 2026 | 5 | 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)
| Arm | Type | Description |
|---|---|---|
| 80 Micrograms | EXPERIMENTAL | Sublingual film containing 80 micrograms Dexmedetomidine |
| 120 Micrograms | EXPERIMENTAL | Sublingual film containing 120 micrograms Dexmedetomidine |
| Placebo | PLACEBO_COMPARATOR | Sublingual Placebo film |
| 60 Micrograms | EXPERIMENTAL | Sublingual film containing 60 micrograms Dexmedetomidine Europe Only |
| Name | Type | Description |
|---|---|---|
| BXCL501 80 Micrograms | DRUG | Sublingual film containing 80 Micrograms BXCL501 |
| Placebo Film | DRUG | Matching Sublingual Placebo film |
| BXCL501 120 Micrograms | DRUG | Sublingual film containing 120 Micrograms BXCL501 |
| BXCL501 60 Micrograms | DRUG | Sublingual film containing 60 Micrograms BXCL501 Europe Only |
Inclusion Criteria: 1. Male and female subjects between the ages of 10-17 years, inclusive, with bipolar disorder (DSM-5 criteria) and 13-17 years, inclusive, in subjects with schizophrenia (DSM-5 criteria). 2. Patients who are judged to be clinically agitated at Screening and Baseline with a total...