A Phase 3 interventional study of Sublingual film containing Dexmedetomidine (BXCL501) and Placebo Film in Agitation Associated With Bipolar Disorder, Agitation,Psychomotor and Bipolar Disorder, sponsored by BioXcel Therapeutics Inc. Completed at 15 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-11.
Sponsored by BioXcel Therapeutics Inc · Phase 3, Interventional, and Treatment
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.
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.
500 studies on the registry are indexed under Psychomotor Agitation; 55 are open to participants now.
This study's enrollment of 380 is above the median of 90 across 413 interventional studies indexed under Psychomotor Agitation.
Browse Psychomotor Agitation studies →BioXcel Therapeutics Inc is the lead sponsor of 15 studies on the registry; 1 is open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 8 (67%) have results posted.
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Exclusion Criteria:
Sublingual film containing 120 Micrograms Dexmedetomidine
Drug: Sublingual film containing Dexmedetomidine (BXCL501)
Sublingual film containing 180 Micrograms Dexmedetomidine
Drug: Sublingual film containing Dexmedetomidine (BXCL501)
Sublingual placebo film
Drug: Placebo Film
Sublingual film containing Dexmedetomidine (BXCL501)
Also known as: Dexmedetomidine
Placebo Film for BXCL501
Also known as: Placebo
Change From Baseline in the Positive and Negative Syndrome Scale- Excited Component (PEC) Total Score
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).
Time frame: Baseline and 120 minutes
Change From Baseline in the Positive and Negative Syndrome Scale- Excited Component (PEC) Total Score Over Time
Effect on agitation onset was measured by change from baseline in the Positive and Negative Syndrome Scale- Excited Component (PEC) total score. 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).
Time frame: Baseline and 20, 30, 45, 60, 90, 120 minutes post-dose
| Milestone | 180 Micrograms | 120 Micrograms | Placebo |
|---|---|---|---|
| Started | 127 | 127 | 126 |
| Completed | 123 | 119 | 120 |
| Not completed | 4 | 8 | 6 |
| Withdrew: Withdrawal by subject | 2 | 3 | 6 |
| Withdrew: Lost to follow-up | 1 | 3 | 0 |
| Withdrew: Adverse event | 0 | 1 | 0 |
| Withdrew: Randomized in error - di dnot receive treatment | 1 | 1 | 0 |
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).
| score on a scale | 180 Micrograms | 120 Micrograms | Placebo |
|---|---|---|---|
| Baseline | 18.0 ± 2.99 | 18.0 ± 2.73 | 17.9 ± 2.94 |
| Change from Baseline at 120 Minutes | -10.4 ± 4.45 | -9.0 ± 5.26 | -4.9 ± 4.67 |
Effect on agitation onset was measured by change from baseline in the Positive and Negative Syndrome Scale- Excited Component (PEC) total score. 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).
| score on a scale | 180 Micrograms | 120 Micrograms | Placebo |
|---|---|---|---|
| Baseline | 18 ± 2.99 | 18 ± 2.73 | 17.9 ± 2.94 |
| Change from Baseline at 20 minutes | -3.1 ± 4.45 | -2.9 ± 3.83 | -1.9 ± 3 |
| Change from Baseline at 30 minutes | -4.6 ± 5.08 | -4.3 ± 4.86 | -2.8 ± 3.85 |
| Change from Baseline at 45 minutes | -6.7 ± 5.12 | -6.3 ± 5.3 | -3.6 ± 4.14 |
| Change from Baseline at 60 minutes | -8.4 ± 5.17 | -7.5 ± 5.19 | -4.4 ± 4.53 |
| Change from Baseline at 90 minutes | -9.7 ± 4.90 | -8.6 ± 5.28 | -4.7 ± 4.52 |
| Change from Baseline at 120 minutes | -10.4 ± 4.45 | -9.0 ± 5.26 | -4.9 ± 4.67 |
Collected over 30 days. Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 180 Micrograms | 0/126 (0%) | 0/126 (0%) | 45/126 (35.7%) |
| 120 Micrograms | 0/126 (0%) | 1/126 (0.8%) | 44/126 (34.9%) |
| Placebo | 0/126 (0%) | 0/126 (0%) | 19/126 (15.1%) |
| Event | 180 Micrograms | 120 Micrograms | Placebo |
|---|---|---|---|
| AgitationNervous system disorders | 0/126 | 1/126 | 0/126 |
| Event | 180 Micrograms | 120 Micrograms | Placebo |
|---|---|---|---|
| SomnolenceNervous system disorders | 27/126 | 26/126 | 6/126 |
| Dry mouthGastrointestinal disorders | 6/126 | 9/126 | 1/126 |
| HypotensionVascular disorders | 8/126 | 6/126 | 0/126 |
| DizzinessNervous system disorders | 7/126 | 7/126 | 1/126 |
| HeadacheNervous system disorders | 2/126 | 6/126 | 6/126 |
| Orthostatic hypotensionVascular disorders | 6/126 | 5/126 | 1/126 |
| NauseaGastrointestinal disorders | 5/126 | 3/126 | 3/126 |
| Hypoesthesia oralGastrointestinal disorders | 5/126 | 2/126 | 1/126 |
Safety population (all participants who received study drug)
| Age, Continuous(years) | 180 Micrograms | 120 Micrograms | Placebo | Total |
|---|---|---|---|---|
| Mean | 45.9 ± 11.3 | 46.1 ± 11.5 | 44.8 ± 12.1 | 45.6 ± 11.6 |
| Sex: Female, Male(Participants) | 180 Micrograms | 120 Micrograms | Placebo | Total |
|---|---|---|---|---|
| Female | 67 | 67 | 73 | 207 |
| Male | 59 | 59 | 53 | 171 |
| Ethnicity (NIH/OMB)(Participants) | 180 Micrograms | 120 Micrograms | Placebo | Total |
|---|---|---|---|---|
| Hispanic or Latino | 15 | 12 | 11 | 38 |
| Not Hispanic or Latino | 111 | 114 | 115 | 340 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | 180 Micrograms | 120 Micrograms | Placebo | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 1 | 0 | 2 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 72 | 68 | 72 | 212 |
| White | 49 | 56 | 50 | 155 |
| More than one race | 3 | 1 | 1 | 5 |
| Unknown or Not Reported | 1 | 1 | 1 | 3 |
| Positive and Negative Syndrome Scale-Excited Component (PEC)(units on a scale) | 180 Micrograms | 120 Micrograms | Placebo | Total |
|---|---|---|---|---|
| Mean | 18.0 ± 3.0 | 18.0 ± 2.7 | 17.9 ± 2.9 | 18.0 ± 2.9 |
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BioXcel Therapeutics Inc