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BXCL501 80 Micrograms · 1 trial · 5 indications
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...