NCT04010305

Sub-Lingual Dexmedetomidine in Agitation Associated With Schizophrenia

A Phase Ib Multicenter, Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study to Determine Efficacy, Pharmacokinetics and Safety of BXCL501 in Agitation Associated With Schizophrenia

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 135 (actual)
• Sponsor: BioXcel Therapeutics Inc · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a two-stage adaptive Phase Ib trial design, that will identify two doses (lowest dose with clinical benefit and highest safe dose) in a first stage and better evaluate safety, tolerability and variability of effect in the second stage.

Detailed description

This is a two-stage adaptive Phase Ib trial design. It is a randomized, double-blind, placebo-controlled, multiple ascending dose study assessing efficacy, pharmacokinetics, safety and tolerability of BXCL501 dosing in adult (18-65 years old) males and females with acute agitation associated with schizophrenia, schizoaffective disorder, or schizophreniform disorder. The first stage will characterize a safe and tolerable dose range that results in a calming effect as measured using the PEC total score. The lowest dose with clear clinical benefit, and the highest safe and well-tolerated dose that demonstrates efficacy in a large proportion of subjects will be selected over the course of testing multiple escalating dose cohorts. The second stage will comprise a total of 40 subjects per dose group in a three-arm placebo-controlled design in order to better characterize the broader range of safety and tolerability as well as better estimate variability (effect size) which may be observed in later phase placebo-controlled trials.

Conditions

• Agitation
• Schizophrenia

Interventions

Type	Name	Description
DRUG	Sublingual film containing BXCL501 (Dexmedetomidine)	Sublingual film containing BXCL501 (Dexmedetomidine) for the treatment of agitation associated with Schizophrenia
DRUG	Placebo film	Placebo film for BXCL501

Timeline

• Start date: 2019-05-22
• Primary completion: 2019-07-31
• Completion: 2019-07-31
• First posted: 2019-07-08
• Last updated: 2023-02-08

Locations

12 sites across 1 country: United States

Regulatory

• FDA-regulated drug study