NCT05025605View on ClinicalTrials.gov

Determining Efficacy and Safety of BXCL501 in Agitation Associated With Pediatric Schizophrenia and Bipolar Disorder

PHASE1RecruitingINTERVENTIONAL
Enrollment

140

Participants

Timeline

Start Date

August 27, 2021

Primary Completion Date

July 31, 2026

Study Completion Date

December 31, 2026

Conditions
SchizophreniaSchizo-Affective DisorderSchizophreniform; SchizophrenicBipolar Disorder IBipolar Disorder II
Interventions
DRUG

BXCL501 80 Micrograms

Sublingual film containing 80 Micrograms BXCL501

DRUG

Placebo Film

Matching Sublingual Placebo film

DRUG

BXCL501 120 Micrograms

Sublingual film containing 120 Micrograms BXCL501

DRUG

BXCL501 60 Micrograms

Sublingual film containing 60 Micrograms BXCL501 Europe Only

Trial Locations (5)

30030

RECRUITING

Bioxcel Clinical Research Site, Decatur

30331

RECRUITING

BioXcel Clinical Research Site, Atlanta

33016

RECRUITING

Bioxcel Clinical Research Site, Hialeah

75115

RECRUITING

BioXcel Clinical Research Site, DeSoto

92805

RECRUITING

BioXcel Clinical Research Site, Anaheim

Sponsors
All Listed Sponsors
collaborator

Cognitive Research Corporation

INDUSTRY

lead

BioXcel Therapeutics Inc

INDUSTRY