Last reviewed · How we verify
NCT05974527
Pilot Study 1: Efficacy and Safety of Sublingual Dexmedetomidine (BXCL501) for the Treatment of Agitation in the Emergency Department
Phase 4 trial testing Sublingual film containing dexmedetomidine (BXCL501) in Agitation. Withdrawn.
30 September 2025
Quick facts
| Lead sponsor | Brigham and Women's Hospital |
|---|---|
| Phase | Phase 4 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Start date | 1 September 2023 |
| Primary completion | 30 September 2025 |
| Estimated completion | 30 June 2026 |
Drugs / interventions tested
- Sublingual film containing dexmedetomidine (BXCL501) — full drug profile →
Conditions studied
- Agitation — all drugs for Agitation →
- Schizophrenia — all drugs for Schizophrenia →
- Schizoaffective Disorder — all drugs for Schizoaffective Disorder →
- Schizophreniform Disorders — all drugs for Schizophreniform Disorders →
Sponsor
Brigham and Women's Hospital
Who can join
18 and older, any sex, with Agitation or Schizophrenia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a single-arm pilot study to examine the impact of BXCL501 (sublingual film formulation of dexmedetomidine) administration on reducing the severity of undifferentiated acute agitation in patients presenting to the emergency department with underlying bipolar disorder or schizophrenia. This study is designed to evaluate BXCL501 for its FDA-approved indication -- treatment of agitation associated with bipolar disorder or schizophrenia -- applied in the emergency department setting.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05974527
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Sublingual film containing dexmedetomidine (BXCL501)
Trials testing the same drug.
- NCT04268303 — Dexmedetomidine in the Treatment of Agitation Associated With Schizophrenia · Phase 3 · completed
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 Brigham and Women's Hospital trials
Trials by the same sponsor.
- NCT07011758 — Dynamic Treatment Regimes for Opioid Use Disorder · Phase 2 · not yet recruiting
- NCT06310018 — Augmented Ultrasound-Facilitated, Catheter-Directed Fibrinolysis for PE · suspended
- NCT04519177 — Randomized Trial of a Sleep Disorders Program on Firefighter Safety and Disability ... · NA · not yet recruiting
- NCT06355986 — Computerized Decision Support to Prevent Stroke in Atrial Fibrillation · NA · not yet recruiting
- NCT06099275 — Evaluation of Hemodynamics in People With Untreated Preeclampsia Using Echocardiography · suspended
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05974527 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Brigham and Women's Hospital
- Last refreshed: 28 January 2026
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/NCT05974527.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing