A Phase 3 interventional study of Sublingual film containing dexmedetomidine (BXCL501) and Placebo Film in Agitation, Schizophrenia and Schizo Affective 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 schizophrenia. The BXCL501-301 study is designed to characterize the efficacy, safety and tolerability of BXCL501 (sublingual film formulation of DEX, HCl) in agitation associated with schizophrenia, schizoaffective disorder or schizophreniform disorder.
The study will enroll approximately 375 subjects randomized 1:1:1 to dose regimens of 180µg, 120µg BXCL501, or placebo. Male and female adults with acute agitation associated with schizophrenia, schizoaffective disorder, or schizophreniform disorder will be enrolled. Eligible subjects 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.
Counted across the registry records on this site, refreshed daily.
A subject will be eligible for inclusion in the study if he or she meets the following criteria:
Exclusion Criteria:
A subject will be excluded from the study if he or she meets the following 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 2 hours
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 10, 20, 30, 45, 60, 90 minutes post-dose
| Milestone | 120 Micrograms | 180 Micrograms | Placebo |
|---|---|---|---|
| Started | 129 | 125 | 126 |
| Completed | 126 | 123 | 123 |
| Not completed | 3 | 2 | 3 |
| Withdrew: Lost to follow-up | 1 | 1 | 2 |
| Withdrew: Withdrawal by subject | 0 | 1 | 1 |
| Withdrew: Adverse event | 2 | 0 | 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 | 120 Micrograms | 180 Micrograms | Placebo |
|---|---|---|---|
| Baseline | 17.5 ± 2.46 | 17.6 ± 2.69 | 17.6 ± 2.26 |
| 2 Hours | -8.4 ± 4.83 | -10.4 ± 4.34 | -4.7 ± 4.69 |
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 | 120 Micrograms | 180 Micrograms | Placebo |
|---|---|---|---|
| Baseline | 17.5 ± 2.46 | 17.6 ± 2.69 | 17.6 ± 2.26 |
| 10 minutes | -1.3 ± 2.50 | -2.0 ± 3.19 | -1.3 ± 2.17 |
| 20 minutes | -2.8 ± 4.03 | -3.9 ± 4.54 | -2.5 ± 3.20 |
| 30 minutes | -4.4 ± 4.90 | -5.7 ± 5.27 | -3.1 ± 3.56 |
| 45 minutes | -5.7 ± 5.18 | -7.6 ± 5.32 | -3.6 ± 3.78 |
| 60 minutes | -6.9 ± 5.06 | -8.8 ± 4.96 | -4.1 ± 4.16 |
| 90 minutes | -8.0 ± 5.00 | -9.8 ± 4.60 | -4.6 ± 4.38 |
Collected over 30 days. Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 120 Micrograms | 0/129 (0%) | 0/129 (0%) | 51/129 (39.5%) |
| 180 Micrograms | 0/126 (0%) | 0/126 (0%) | 47/126 (37.3%) |
| Placebo | 0/126 (0%) | 0/126 (0%) | 19/126 (15.1%) |
| Event | 120 Micrograms | 180 Micrograms | Placebo |
|---|---|---|---|
| SomnolenceNervous system disorders | 28/129 | 29/126 | 10/126 |
| Dry mouthGastrointestinal disorders | 10/129 | 5/126 | 2/126 |
| DizzinessNervous system disorders | 3/129 | 8/126 | 1/126 |
| HypotensionVascular disorders | 8/129 | 5/126 | 0/126 |
| Hypoesthesia oralNervous system disorders | 5/129 | 7/126 | 0/126 |
| Orthostatic hypotensionVascular disorders | 2/129 | 7/126 | 0/126 |
| HeadacheNervous system disorders | 6/129 | 4/126 | 6/126 |
| Paresthesia oralNervous system disorders | 5/129 | 3/126 | 1/126 |
Safety population (all participants who received study drug). One participant enrolled and randomized to the 120 μg group was enrolled a second time at a different site and randomized to the 180 μg group. The data from the first enrollment and treatment (120 μg) were included in the efficacy analyses. The data from both enrollments (120 μg and 180 μg) were included in the safety analyses and counted separately for each treatment group.
| Age, Continuous(years) | 120 Micrograms | 180 Micrograms | Placebo | Total |
|---|---|---|---|---|
| Mean | 45.7 ± 11.3 | 46.0 ± 11.9 | 45.1 ± 11.1 | 45.6 ± 11.4 |
| Sex: Female, Male(Participants) | 120 Micrograms | 180 Micrograms | Placebo | Total |
|---|---|---|---|---|
| Female | 52 | 43 | 44 | 139 |
| Male | 77 | 82 | 82 | 241 |
| Ethnicity (NIH/OMB)(Participants) | 120 Micrograms | 180 Micrograms | Placebo | Total |
|---|---|---|---|---|
| Hispanic or Latino | 17 | 13 | 7 | 37 |
| Not Hispanic or Latino | 112 | 112 | 119 | 343 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | 120 Micrograms | 180 Micrograms | Placebo | Total |
|---|---|---|---|---|
| Black or African American | 92 | 102 | 102 | 296 |
| White | 33 | 21 | 21 | 75 |
| Other | 4 | 2 | 3 | 9 |
| Hispanic or Latino | 17 | 13 | 7 | 37 |
| Positive and Negative Syndrome Scale-Excited Component(units on a scale) | 120 Micrograms | 180 Micrograms | Placebo | Total |
|---|---|---|---|---|
| Mean | 17.5 ± 2.5 | 17.6 ± 2.7 | 17.6 ± 2.3 | 17.6 ± 2.5 |
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BioXcel Therapeutics Inc