Sub-Lingual Dexmedetomidine in Agitation Associated With Schizophrenia

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04010305
Study type	Interventional
Source	BioXcel Therapeutics Inc
Contact
Status	Completed
Phase	Phase 1
Start date	May 22, 2019
Completion date	July 31, 2019

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