Trials / Completed
CompletedNCT04276883
Dexmedetomidine in the Treatment of Agitation Associated With Bipolar Disorder
A Phase III Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine Efficacy and Safety of BXCL501 In Agitation Associated With Bipolar Disorder
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 380 (actual)
- Sponsor
- BioXcel Therapeutics Inc · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This is a definitive study to support the safety and efficacy evaluation of BXCL501 for the acute treatment of agitation in bipolar disorder. The BXCL501-302 study is designed to characterize the efficacy, safety and tolerability of BXCL501 (sublingual film formulation of DEX, HCl) in agitation associated with bipolar disorder.
Detailed description
The study will enroll approximately 375 subjects randomized 1:1:1 to dose regimens of 180µg, 120µg BXCL501, or placebo stratified by age \< 65 and age ≥ 65. Male and female adults with acute agitation associated with bipolar disorder will be enrolled. Eligible subjects (acutely agitated subjects with bipolar disorder, generally hypomanic, manic or mixed episodes) may be identified in outpatient clinics, mental health, psychiatric or medical emergency services including medical/psychiatric observation units, or as newly admitted to a hospital setting for acute agitation or already in hospital for chronic underlying conditions. Subjects will be domiciled in a clinical research setting or hospitalized to remain under medical supervision while undergoing screening procedures to assess eligibility. Efficacy and safety assessments will be conducted periodically before and after dosing.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Sublingual film containing Dexmedetomidine (BXCL501) | Sublingual film containing Dexmedetomidine (BXCL501) |
| DRUG | Placebo Film | Placebo Film for BXCL501 |
Timeline
- Start date
- 2020-02-24
- Primary completion
- 2020-05-21
- Completion
- 2020-05-21
- First posted
- 2020-02-19
- Last updated
- 2023-09-11
- Results posted
- 2023-09-11
Locations
15 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04276883. Inclusion in this directory is not an endorsement.