drugset / Trial / NCT04251910
Sub-Lingual Dexmedetomidine in Agitation Associated With Dementia
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This is an adaptive Phase 1b/2 trial design. It is randomized, double-blind, placebo-controlled, multiple ascending dose study assessing efficacy, pharmacokinetics, safety and tolerability of BXCL-501 dosing in adult (65 years and older) males and females with acute agitation associated with dementia. Evaluation of 3 doses are planned.
Timeline
- Start
- 2019-12-27
- Primary completion
- 2022-01-24
- Completion
- 2022-01-24
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Dexmedetomidine | Other / unclassified | 30 ug | Other |
| Comparator | Dexmedetomidine | Other / unclassified | 40 ug | Other |
| Comparator | Dexmedetomidine | Other / unclassified | 60 ug | Other |
| Comparator | Dexmedetomidine | Other / unclassified | 90 ug | Other |