trial

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

NCTId NCT05025605
as of 2026-07-01
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at a glance
Phase 1 · Recruiting
Enrollment 140 (estimated)
Sponsored by BioXcel Therapeutics Inc
Primary completion 2027-07-31
Synthesized from structured facts only — each point cited above.

Design & status

Phase
Phase 1
Status
Recruiting
Enrollment
140 (estimated)
Study type
Interventional
Allocation
Randomized
Model
Parallel
Masking
Double
Start
2021-08-27
Primary completion
2027-07-31
Eligibility
ALL · 10 Years · 17 Years

Interventions & indications

Drugs
BXCL501 80 MicrogramsBXCL501 120 MicrogramsBXCL501 60 Micrograms

Sponsors

BioXcel Therapeutics IncLead Sponsor
ProPharma GroupCollaborator

Investigators

1
Robert Risinger, MDStudy Chair

Sites

5 total
Anaheim, United StatesHialeah, United StatesAtlanta, United StatesDecatur, United StatesDeSoto, United States

Facts & assertions

4 sourced
Enrollment
140
Phase
PHASE1
Primary Completion Date
2027-07-31
Status
RECRUITING
relationships
The graph out of here
drug
BXCL501 80 Micrograms
drug
BXCL501 120 Micrograms
drug
BXCL501 60 Micrograms
drug
lead_sponsor
BioXcel Therapeutics Inc
company
collaborator
ProPharma Group
company
indication
Bipolar Disorder
indication
Bipolar Disorder I
indication
Schizo-affective Disorder
indication
investigator
Robert Risinger, MD
person