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Also known as Sublingual film containing BXCL501 (Dexmedetomidine)
film containing BXCL501 · 1 trial · 2 indications
Positive and Negative Syndrome Scale - Excited Component (PEC). The 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 to 35.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Sublingual Film with no active drug; single administration with the possibility of repeating dose after 1 hour in case of lack of significant efficacy |
| 20 micrograms | EXPERIMENTAL | Sublingual Film containing 20 micrograms BXCL501; single administration with the possibility of repeating dose after 1 hour in case of lack of significant efficacy |
| 60 micrograms | EXPERIMENTAL | Sublingual Film containing 60 micrograms BXCL501; single administration with the possibility of repeating dose after 1 hour in case of lack of significant efficacy |
| 120 micrograms | EXPERIMENTAL | 2 Sublingual Films, each containing 60 micrograms BXCL501; single administration of 2 films with the possibility of repeating dose after 1 hour in case of lack of significant efficacy |
| 180 micrograms | EXPERIMENTAL | 2 Sublingual Films, each containing 60 micrograms BXCL501. |
| Name | Type | Description |
|---|---|---|
| Sublingual film containing BXCL501 (Dexmedetomidine) | DRUG | Sublingual film containing BXCL501 (Dexmedetomidine) for the treatment of agitation associated with Schizophrenia |
| Placebo film | DRUG | Placebo film for BXCL501 |
Inclusion Criteria: 1. Male and female patients between the ages of 18 to 65 years, inclusive. 2. Patients who have met Diagnostic and Statistical Manual (DSM) -5 criteria for schizophrenia, schizoaffective, or schizophreniform disorder. 3. Patients who are judged to be clinically agitated at Basel...