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NCT04276883 · ClinicalTrials.gov registry record · Phase 3
Dexmedetomidine in the Treatment of Agitation Associated With Bipolar Disorder
A Phase 3 study of Bipolar Disorder and Agitation,Psychomotor, sponsored by BioXcel Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 380
- Enrollment target
- 15
- Study locations
NCT04276883: Completed Phase 3 study of Bipolar Disorder and Agitation,Psychomotor, sponsored by BioXcel Therapeutics.
NCT04276883 is a Phase 3 study of Bipolar Disorder and Agitation,Psychomotor that has completed, run by BioXcel Therapeutics. The registered enrollment target is 380 participants, above the 330-participant average among 162 other Bipolar Disorder trials with a reported enrollment target (15% higher). The trial reports 15 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04276883, a Phase 3 study of Bipolar Disorder and Agitation,Psychomotor, has completed, sponsored by BioXcel Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 380 participants
- Enrollment target
- 15
- Study locations
Study 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.
Primary Outcome
The Positive and Negative Syndrome Scale-Excited Component (PEC) includes 5 items-poor impulse control, tension, hostility, uncooperativeness, and excitement-each of which is rated from 1 (minimum) to 7 (maximum); the sum of these 5 items, the PEC total score, ranges from 5 (absence of agitation) to 35 (extremely severe).
Conditions Studied
Interventions
- DRUG Placebo Film
- DRUG Sublingual film containing Dexmedetomidine (BXCL501)
Study Locations (15)
California
- BioXcel Clinical Research Site - Cerritos
- BioXcel Clinical Research Site - Culver City
- BioXcel Clinical Research Site - Long Beach
- BioXcel Clinical Research Site - Orange
Texas
- BioXcel Clinical Research Site - Austin
- BioXcel Clinical Research Site - DeSoto
- BioXcel Clinical Research Site - Richardson
New Jersey
- BioXcel Clinical Research Site - Berlin
- BioXcel Clinical Research Site - Marlton
Arkansas
- BioXcel Clinical Research Site - Little Rock
Florida
- BioXcel Clinical Research Site - Miami Lakes
Illinois
- BioXcel Clinical Research Site - Chicago
Maryland
- BioXcel Clinical Research Site - Gaithersburg
Nevada
- BioXcel Clinical Research Site - Las Vegas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 380 participants |
| Start Date | 2020-02-24 |
| Est. Completion | 2020-05-21 |
| Phase | Phase 3 |
What the finished NCT04276883 record still lists
NCT04276883 is an interventional study that assigns participants to a tested intervention. The registered 380 participants enrollment target is mid-sized for trials with a published cap, above the 330-participant average among 162 other Bipolar Disorder trials with a reported enrollment target (15% higher).
The record links to 3 conditions, with Bipolar Disorder appearing as the primary indexed condition, and to 2 interventions - of which Placebo Film is the first listed.
NCT04276883 lists 15 locations in 9 states (California, Texas, New Jersey).
Frequently Asked Questions
What is clinical trial NCT04276883 about?
NCT04276883 is a clinical study titled "Dexmedetomidine in the Treatment of Agitation Associated With Bipolar Disorder". 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 asso...
What is the current status of trial NCT04276883?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 380 participants. The study started on 2020-02-24. Estimated completion is 2020-05-21.
What conditions does trial NCT04276883 study?
This clinical trial studies the following conditions: Bipolar Disorder, Agitation,Psychomotor, Agitation Associated With Bipolar Disorder.
What interventions are being tested in trial NCT04276883?
The interventions under investigation include: Placebo Film (DRUG), Sublingual film containing Dexmedetomidine (BXCL501) (DRUG).
Who is sponsoring clinical trial NCT04276883?
This trial is sponsored by BioXcel Therapeutics, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04276883 being conducted?
This trial has 15 study locations across Arkansas, California, Florida, Illinois, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04276883's enrollment target sits among peer trials
380 20th of 162 higher than 143 of 162 other Bipolar Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Bipolar Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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