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Alpha-2A Adrenergic Receptor Agonist

BXCL501 for Pediatric Schizophrenia and Bipolar Agitation

Phase 1
Recruiting
Research Sponsored by BioXcel Therapeutics Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male and female subjects between the ages of 10-17 years with bipolar disorder (DSM-5 criteria)
Male and female subjects between the ages of 13-17 years with schizophrenia (DSM-5 criteria)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90, 60, 45, 30, 20,10 minutes - group one only

Summary

This trial shows that BXCL501 is safe and effective in treating children and adolescents with bipolar disorder or schizophrenia who are experiencing acute agitation.

Who is the study for?
This trial is for children and teens aged 10-17 with bipolar disorder, and those aged 13-17 with schizophrenia who are experiencing significant agitation. They must have a specific level of agitation on the PANSS Excited Component scale and agree to use effective birth control. It's not for those who've used certain sedatives recently, are at suicide risk, have serious health issues, or have taken experimental drugs within the last month.
What is being tested?
The study tests BXCL501 at different doses (60, 80, and 120 micrograms) against a placebo to see if it helps calm down kids and teens with bipolar disorder or schizophrenia during acute agitation episodes. The effectiveness and safety of these treatments are being compared.
What are the potential side effects?
While the side effects aren't specified here, common ones for psychiatric medications like BXCL501 could include drowsiness, headache, stomach upset, changes in appetite or weight; mood swings; dry mouth; increased saliva production; or restlessness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 10-17 years old and have been diagnosed with bipolar disorder.
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I am a teenager aged 13-17 with schizophrenia.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90, 60, 45, 30, 20,10 minutes - group one only
This trial's timeline: 3 weeks for screening, Varies for treatment, and 90, 60, 45, 30, 20,10 minutes - group one only for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Syndrome

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: 80 MicrogramsExperimental Treatment1 Intervention
Sublingual film containing 80 micrograms Dexmedetomidine
Group II: 60 MicrogramsExperimental Treatment1 Intervention
Sublingual film containing 60 micrograms Dexmedetomidine Europe Only
Group III: 120 MicrogramsExperimental Treatment1 Intervention
Sublingual film containing 120 micrograms Dexmedetomidine
Group IV: PlaceboPlacebo Group1 Intervention
Sublingual Placebo film

Find a Location

Who is running the clinical trial?

BioXcel Therapeutics IncLead Sponsor
19 Previous Clinical Trials
2,215 Total Patients Enrolled
5 Trials studying Schizophrenia
1,020 Patients Enrolled for Schizophrenia
Cognitive Research CorporationIndustry Sponsor
24 Previous Clinical Trials
2,248 Total Patients Enrolled
4 Trials studying Schizophrenia
881 Patients Enrolled for Schizophrenia
Robert Risinger, MDStudy ChairBioXcel Therapeutics
10 Previous Clinical Trials
1,685 Total Patients Enrolled
5 Trials studying Schizophrenia
1,191 Patients Enrolled for Schizophrenia

Media Library

BXCL501 (Alpha-2A Adrenergic Receptor Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT05025605 — Phase 1
Schizophrenia Research Study Groups: 80 Micrograms, 120 Micrograms, Placebo, 60 Micrograms
Schizophrenia Clinical Trial 2023: BXCL501 Highlights & Side Effects. Trial Name: NCT05025605 — Phase 1
BXCL501 (Alpha-2A Adrenergic Receptor Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05025605 — Phase 1
~47 spots leftby Jul 2026
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