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Also known as BXCL501 Sublingual Film
BXCL501 Film · 1 trial · 6 indications
The aim of the study is to assess the agreement/correlations among different measures so the comment is correct that different units of measure are being assessed. The informant-completed questionnaire (modified clinical global impression of severity for informants (mCGI-S-INF) and the clinical-rater completed questionnaire, Positive and Negative Syndrome Scale - Excited Component (PEC) are the primary outcomes being assessed. The mCGI-S-INF is a single item with a 0 to 3 point scale with higher values indicating more severe agitation. The PEC is a five item questionnaire with 7-point response options, overall scores range from 5 to 35 with higher scores indicating more severe agitation.
Assess content validity of the Modified Clinical Global Impression of Severity for Informants (mCGI-S-INF) and informant training materials. The scale being utilized is mCGI-S-INF. There is no score as it is a qualitative assessment and it is being validated to measure patient informant reported outcomes against patient reported outcomes (mCGI-S-PAT) and physician reported outcomes using the Positive and Negative Syndrome Scale - Excited Component (PEC) scale where the highest score indicates the maximum agitation that could be experienced.
| Arm | Type | Description |
|---|---|---|
| BXCL501 Sublingual film | EXPERIMENTAL | Experimental: 120 mcg of BXCL501 Sublingual film containing 120 Micrograms Dexmedetomidine |
| Name | Type | Description |
|---|---|---|
| BXCL501 Sublingual Film | DRUG | Single dose BXCL501 120 mcg |
Inclusion Criteria for Participant: 1. Male and female patients 18 to 75 years old, inclusive. 2. Patients who can read, understand, and provide written informed consent. 3. Patients who meet the Diagnostic and Statistical Manual of Mental Disorders, v5, Text Revision (DSM-5-TR) criteria for a prim...
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BXCL501 Film is an investigational sublingual film developed by BioXcel Therapeutics, Inc. for psychiatric conditions, including Bipolar I Disorder. It is a small-molecule product in Phase 2 clinical development. The film is placed under the tongue rather than swallowed.
BXCL501 Film is being studied in Bipolar I Disorder as part of a Phase 2 program. The completed trial enrolled participants with Bipolar I Disorder alongside other conditions, including Bipolar II Disorder, schizophrenia, schizoaffective disorder, schizophreniform disorders, and psychomotor agitation, and assessed acute psychomotor agitation measures.
BXCL501 Film is developed by BioXcel Therapeutics, Inc., which trades under the ticker BTAIQ. The company is the sponsor behind the sublingual film program, which is in Phase 2 development for Bipolar I Disorder and related psychiatric conditions.
BXCL501 Film is in Phase 2 clinical development. It is an investigational product and is not described as approved for any use. The Phase 2 program consists of one completed trial, and no trials are currently listed as active.
BXCL501 Film has been studied in one completed Phase 2 trial, NCT07116694, titled Assessment of Acute Psychomotor Agitation Measures Associated With Schizophrenia and Bipolar Disorder. The trial enrolled 33 participants in the United States, ages 18 and older, and was an uncontrolled study without randomization or blinding.
Yes, BXCL501 Film and BXCL501 Sublingual Film refer to the same product from BioXcel Therapeutics, Inc. The sublingual name describes the film formulation, which is placed under the tongue. Both names point to the same Phase 2 small-molecule program being studied in Bipolar I Disorder.