Phase 3TerminatedAge-related condition
Dexmedetomidine in the Treatment of Agitation Associated With Dementia (TRANQUILITY III)
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of PRN Dosing of BXCL501 Over a 12 Week Treatment Period in Subjects With Agitation Associated With Dementia Who Require at Least Moderate To Full Assistance With Activities of Daily Living
- Sponsor
- BioXcel Therapeutics Inc (Industry)
- Enrolment
- 13 enrolled
- Conditions
- Agitation; Dementia
- Interventions
- BXCL501; Matching Placebo
- Ages
- older adults
- Registry
- NCT05665088
Full record on ClinicalTrials.gov
From the registry
A study to determine the safety and efficacy of BXCL501 dosing for episodes of agitation associated with dementia when they occur (given as needed \[PRN\]), for a maximum of 168 doses within a 12-week treatment period.
Primary outcomes
- Change From Pre-dose in PEC Total Score at 30 Minutes Post-dose for the First Treated Episode of Agitation
- Change From Pre-dose in PEC Total Score at 1 Hour Post-dose for the First Treated Episode of Agitation
- Change From Pre-dose in PEC Total Score at 2 Hours Post-dose for the First Treated Episode of Agitation
- Change From Pre-dose in PEC Total Score at 4 Hours Post-dose for the First Treated Episode of Agitation
History
Results first posted
Last registry update
Primary completion
Registered
Started