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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...
The film containing BXCL501 is being developed for the treatment of agitation, including agitation associated with schizophrenia. It is a sublingual film formulation studied in adult patients with agitation and schizophrenia in a completed Phase 1 clinical trial.
The film containing BXCL501 is being developed by BioXcel Therapeutics, Inc., which trades on the Nasdaq under the ticker symbol BTAI. The company is responsible for the clinical development of this sublingual film formulation.
The film containing BXCL501 is in Phase 1 clinical development. It has completed one Phase 1 trial and is not yet approved by the FDA. It has received Breakthrough Therapy and Fast Track designations from the FDA for its development program.
The film containing BXCL501 has been studied in a completed Phase 1 trial, NCT04010305, titled Sub-Lingual Dexmedetomidine in Agitation Associated With Schizophrenia. The trial enrolled 135 participants in the United States and was randomized, double-blind, and placebo-controlled.
Yes, the film containing BXCL501 is also known as sublingual film containing BXCL501 (dexmedetomidine). BXCL501 is the investigational code name for this sublingual film formulation of dexmedetomidine, which is being developed for agitation.