Adults 18 to 75, any sex, with Agitation or Schizophrenia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change From Baseline in the Positive and Negative Syndrome Scale- Excited Component (PEC) Total ScorePrimary· Baseline and 2 hours
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).
Baseline
Group
Value
95% CI
120 Micrograms
17.5
± 2.46
180 Micrograms
17.6
± 2.69
Placebo
17.6
± 2.26
2 Hours
Group
Value
95% CI
120 Micrograms
-8.4
± 4.83
180 Micrograms
-10.4
± 4.34
Placebo
-4.7
± 4.69
Change From Baseline in the Positive and Negative Syndrome Scale- Excited Component (PEC) Total Score Over TimeSecondary· Baseline and 10, 20, 30, 45, 60, 90 minutes post-dose
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).
Baseline
Group
Value
95% CI
120 Micrograms
17.5
± 2.46
180 Micrograms
17.6
± 2.69
Placebo
17.6
± 2.26
10 minutes
Group
Value
95% CI
120 Micrograms
-1.3
± 2.50
180 Micrograms
-2.0
± 3.19
Placebo
-1.3
± 2.17
20 minutes
Group
Value
95% CI
120 Micrograms
-2.8
± 4.03
180 Micrograms
-3.9
± 4.54
Placebo
-2.5
± 3.20
30 minutes
Group
Value
95% CI
120 Micrograms
-4.4
± 4.90
180 Micrograms
-5.7
± 5.27
Placebo
-3.1
± 3.56
45 minutes
Group
Value
95% CI
120 Micrograms
-5.7
± 5.18
180 Micrograms
-7.6
± 5.32
Placebo
-3.6
± 3.78
60 minutes
Group
Value
95% CI
120 Micrograms
-6.9
± 5.06
180 Micrograms
-8.8
± 4.96
Placebo
-4.1
± 4.16
90 minutes
Group
Value
95% CI
120 Micrograms
-8.0
± 5.00
180 Micrograms
-9.8
± 4.60
Placebo
-4.6
± 4.38
Adverse events — posted to ClinicalTrials.gov
Time frame: 30 days.
Reporting threshold: 3%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
Other trials of Sublingual film containing dexmedetomidine (BXCL501)
Trials testing the same drug.
NCT05974527 — Pilot Study 1: Efficacy and Safety of Sublingual Dexmedetomidine (BXCL501) for the Treatment of Agitation in the Emergen
· Phase 4
· withdrawn
Other recruiting trials for Agitation
Currently open trials in the same condition.
NCT06937229 — A Study to Evaluate the Long-term Efficacy and Safety of KarXT + KarX-EC for Agitation in Alzheimer's Disease (ADAGIO-3)
· Phase 3
· recruiting
NCT05522647 — Detection of Risk Behaviors: Pilot Observational Study With Bedridden and Agitated Patients.
· recruiting
NCT06808984 — Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986368, for the Treatment of Agitation in Participants W
· Phase 2
· recruiting
Other BioXcel Therapeutics Inc trials
Trials by the same sponsor.
NCT07116694 — Assessment of Acute Psychomotor Agitation Measures Associated With Schizophrenia and Bipolar Disorder
· Phase 2
· completed
NCT06041646 — Tachyphylaxis, Tolerance, & Withdrawal Post Treatment With Igalmi for Agitation in Schizophrenia or Bipolar Disorder
· Phase 4
· completed
NCT05665088 — Dexmedetomidine in the Treatment of Agitation Associated With Dementia (TRANQUILITY III)
· Phase 3
· terminated
NCT05658510 — Dexmedetomidine in the Treatment of Agitation Associated With Schizophrenia and Bipolar Disorder (SERENITY III)
· Phase 3
· completed
NCT05271552 — Dexmedetomidine in the Treatment of Agitation Associated With Dementia (TRANQUILITY II)
· Phase 3
· completed
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by BioXcel Therapeutics Inc
Last refreshed: 18 June 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04268303.