At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase Ib/II, Multicenter, Randomized, Double Blind, Placebo Controlled, Ascending Dose Finding, Efficacy, Pharmacokinetic and Safety Study of BXCL501 In Agitation Associated With Dementia
In Brief
A Phase 1 clinical trial evaluating Sublingual film containing Dexmedetomidine and Sublingual Placebo Film for Agitation,Psychomotor and Dementia. Completed, enrolled 100 participants across 5 sites.
Signals
Detailed 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.
Study Details
Timeline
Arms & Interventions
Cohort 1 consists of 10 patients out of whom 8 patients receive 30 Micrograms film and the remaining 2 patients receive a placebo
Cohort 2 consists of 10 patients out of whom 8 patients receive 60 Micrograms film and the remaining 2 patients receive a placebo. Additional 20 subjects receive 60 Micrograms or placebo.
Cohort 3 consists of 10 patients out of whom 8 patients receive 90 Micrograms film and the remaining 2 patients receive a placebo
Part B cohort consists 46 subjects receiving 40 Micrograms or placebo
Interventions
Sublingual film containing Dexmedetomidine
Sublingual placebo film that matches BXCL501