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NCT04010305
Sub-Lingual Dexmedetomidine in Agitation Associated With Schizophrenia
Phase 1 trial testing Sublingual film containing BXCL501 (Dexmedetomidine) in Agitation in 135 participants. Completed in 31 July 2019.
31 July 2019
Quick facts
| Lead sponsor | BioXcel Therapeutics Inc |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 135 |
| Start date | 22 May 2019 |
| Primary completion | 31 July 2019 |
| Estimated completion | 31 July 2019 |
| Sites | 12 locations across United States |
Drugs / interventions tested
- Sublingual film containing BXCL501 (Dexmedetomidine) — full drug profile →
- Placebo film — full drug profile →
Conditions studied
- Agitation — all drugs for Agitation →
- Schizophrenia — all drugs for Schizophrenia →
Sponsor
BioXcel Therapeutics Inc — full company profile →
Who can join
Adults 18 to 65, any sex, with Agitation or Schizophrenia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a two-stage adaptive Phase Ib trial design, that will identify two doses (lowest dose with clinical benefit and highest safe dose) in a first stage and better evaluate safety, tolerability and variability of effect in the second stage.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04010305
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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
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 NCT04010305 (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 BioXcel Therapeutics Inc
- Last refreshed: 8 February 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/NCT04010305.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing