At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 151 enrolled
Drug / intervention
BXCL501 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Efficacy And Safety Study of PRN Dosing of BXCL501 Over A 12 Week Period In Subjects With Agitation Associated With Dementia
In Brief
A Phase 3 clinical trial evaluating BXCL501 and Matching Placebo for Agitation and Dementia. Completed, enrolled 151 participants across 11 sites.
Detailed Summary
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 28 doses within a 12-week treatment period.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsCognitive Research Corporation
Timeline
Phase 3CompletedFinished
2023202420252026
First PostedMar 2022
Enrollment StartApr 2022
Primary CompletionApr 2023
TodayJul 2026
First PostedMar 9, 2022
Enrollment StartApr 27, 2022
Primary CompletionApr 21, 2023
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 4.3 years ago
Interventions
BXCL501drug
Sublingual Film
Matching Placebodrug
Sublingual Placebo Film