drugset / Trial / NCT04251910

Sub-Lingual Dexmedetomidine in Agitation Associated With Dementia

NCT04251910

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

EvaluationDrugModalityDoseRoute
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

Indications