CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 380 enrolled / 380 target
Drug / intervention
Sublingual film containing Dexmedetomidine (BXCL501) +1 moredrug
Likely dose
120 Microgramsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04276883
NCT04276883Phase 3CompletedOn Track (5.0/mo)Completion was 73mo ago
CompareCT.gov

A Phase III Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine Efficacy and Safety of BXCL501 In Agitation Associated With Bipolar Disorder

BioXcel Therapeutics Inc·interventional·Posted Feb 19, 2020·Updated Jun 4, 2026

In Brief

A Phase 3 clinical trial evaluating Sublingual film containing Dexmedetomidine (BXCL501) and Placebo Film for Agitation Associated With Bipolar Disorder and 2 related conditions. Completed, enrolled 380 participants across 15 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAgitation Associated With Bipolar Disorder, Agitation,Psychomotor, Bipolar Disorder
CountriesUnited States
CollaboratorsCognitive Research Corporation

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedFeb 19, 2020
Enrollment StartFeb 24, 2020
Primary CompletionMay 21, 2020
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 6.4 years ago

Arms & Interventions

120 Microgramsexperimental

Sublingual film containing 120 Micrograms Dexmedetomidine

Drug: Sublingual film containing Dexmedetomidine (BXCL501)
180 Microgramsexperimental

Sublingual film containing 180 Micrograms Dexmedetomidine

Drug: Sublingual film containing Dexmedetomidine (BXCL501)
Placeboplacebo_comparator

Sublingual placebo film

Drug: Placebo Film

Interventions

Sublingual film containing Dexmedetomidine (BXCL501)drug

Sublingual film containing Dexmedetomidine (BXCL501)

Placebo Filmdrug

Placebo Film for BXCL501