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

Part of paid clinical trials in Anaheim, California.

Sponsor
BioXcel Therapeutics Inc
Study ID
NCT05025605
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Bipolar Disorder I
  • Bipolar Disorder II
  • Schizo-Affective Disorder
  • Schizophrenia
  • Schizophreniform; Schizophrenic

Eligibility Criteria

Sex
ALL
Age
10 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • BXCL501 80 Micrograms — DRUG
    Sublingual film containing 80 Micrograms BXCL501
  • Placebo Film — DRUG
    Matching Sublingual Placebo film
  • BXCL501 120 Micrograms — DRUG
    Sublingual film containing 120 Micrograms BXCL501
  • BXCL501 60 Micrograms — DRUG
    Sublingual film containing 60 Micrograms BXCL501 Europe Only

Study Details

This is a study of the efficacy and safety of BXCL501 in children and adolescents with acute agitation and either bipolar disorder or schizophrenia.

Key Dates

Start date
Aug 27, 2021
Status verified
Apr 2026
Primary completion
Jul 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
140 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 80 Micrograms
    Sublingual film containing 80 micrograms Dexmedetomidine
  • Experimental: 120 Micrograms
    Sublingual film containing 120 micrograms Dexmedetomidine
  • Placebo Comparator: Placebo
    Sublingual Placebo film
  • Experimental: 60 Micrograms
    Sublingual film containing 60 micrograms Dexmedetomidine Europe Only

Primary Outcome Measure

Absolute change from baseline in the Positive and Negative Syndrome Scale - Excited Component (PEC) total score [ Time Frame: 120 minutes - Group one only ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
BioXcel Clinical Research SiteAnaheimCalifornia92805
BioXcel CTM
[email protected]
475-254-5899
Bioxcel Clinical Research SiteHialeahFlorida33016
Bioxcel CTM
[email protected]
475-254-5899
BioXcel Clinical Research SiteAtlantaGeorgia30331-
Bioxcel Clinical Research SiteDecaturGeorgia30030
Bioxcel CTM
[email protected]
475-254-5899
BioXcel Clinical Research SiteDeSotoTexas75115
Bioxcel CTM
[email protected]
475-254-5899

Find similar trials in Anaheim, CA

By condition
Schizophrenia
By specialty
PsychiatryMental healthBehavioral health
By research site
BioXcel Clinical Research Site· Anaheim, CABioxcel Clinical Research Site· Hialeah, FLBioXcel Clinical Research Site· Atlanta, GABioxcel Clinical Research Site· Decatur, GABioXcel Clinical Research Site· DeSoto, TX

Related Studies