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Alpha-2 Adrenergic Receptor Agonist

Dexmedetomidine for Agitation in Schizophrenia and Bipolar Disorder

Phase 3
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
Patients who have met Diagnostic and Statistical Manual5/5-Text Revision criteria for bipolar I or bipolar II disorder, schizophrenia, schizoaffective or schizophreniform disorder
Patients have had at least three clinical presentations of agitation requiring an intervention in the past three months prior to Screening (Part 2 only)
Must not have
Patients currently treated with alpha-1 noradrenergic blockers (terazosin, doxazosin, tamsulosin, alfuzosin, or prazosin), alpha-2 adrenergic agonists, or other prohibited medications
History of syncope or other syncopal attacks, current evidence of hypovolemia, or orthostatic hypotension
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, and 2, 4, 6, and 8 hours postdose
Awards & highlights
Pivotal Trial

Summary

This trial tests an investigational medication for treating episodes of agitation in bipolar I/II, schizophrenia, schizoaffective and schizophreniform disorder. It compares the drug to a placebo.

Who is the study for?
Adults aged 18-75 with bipolar I or II, schizophrenia, schizoaffective, or schizophreniform disorder who've had recent agitation episodes may join. They must be in good health based on medical exams and agree to use birth control. Exclusions include certain mental disorders pre-dating their diagnosis, recent investigational drug use, specific medication treatments, pregnancy/breastfeeding women, and those with serious neurological conditions.
What is being tested?
The trial is testing BXCL501 against a placebo for reducing agitation in patients with bipolar disorder or schizophrenia-related conditions. Participants are randomly assigned to receive either the study drug or a placebo to compare effectiveness.
What are the potential side effects?
Potential side effects of BXCL501 could include reactions similar to other medications affecting the brain's chemistry such as drowsiness, dry mouth, low blood pressure when standing up (orthostatic hypotension), and possible heart rhythm changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with bipolar disorder, schizophrenia, or a related condition.
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I've needed help for agitation 3 times in the last 3 months.
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I needed help for agitation in the last month.
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I am between 18 and 75 years old.
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I have been diagnosed with bipolar disorder, schizophrenia, or a related condition.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not taking medications like terazosin, doxazosin, or similar drugs.
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I have a history of fainting or currently have low blood volume or blood pressure issues when standing.
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I have previously taken IGALMI™ or participated in a trial for BXCL501.
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I am not pregnant or breastfeeding.
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I have a history of serious brain or neurological conditions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, and 2, 4, 6, and 8 hours postdose
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, and 2, 4, 6, and 8 hours postdose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Part 1: Change from baseline in Positive and Negative Syndrome Scale - Excited (PEC) total score
Part 2: The incidence of SAEs and TEAEs compared with placebo.
Secondary study objectives
Part 1: Change from baseline in heart rate (HR) at rest
Part 1: Change from baseline in heart rate (HR) under orthostatic stress
Part 1: Change from baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP) at rest
+10 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Part 2: 120 mcg of BXCL501Experimental Treatment1 Intervention
Sublingual film containing 120 Micrograms Dexmedetomidine
Group II: Part 1: 60 mcg of BXCL501Experimental Treatment1 Intervention
Sublingual film containing 60 Micrograms Dexmedetomidine
Group III: Part 2: Matching PlaceboPlacebo Group1 Intervention
Sublingual Placebo film
Group IV: Part 1: Matching PlaceboPlacebo Group1 Intervention
Sublingual Placebo film
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BXCL501
2022
Completed Phase 3
~160

Find a Location

Who is running the clinical trial?

BioXcel Therapeutics IncLead Sponsor
19 Previous Clinical Trials
1,905 Total Patients Enrolled
Worldwide Clinical TrialsOTHER
65 Previous Clinical Trials
14,410 Total Patients Enrolled
Robert Risinger, MDStudy ChairBioXcel Therapeutics
10 Previous Clinical Trials
1,375 Total Patients Enrolled

Media Library

BXCL501 (Alpha-2 Adrenergic Receptor Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT05658510 — Phase 3
Schizoaffective Disorder Research Study Groups: Part 1: 60 mcg of BXCL501, Part 2: 120 mcg of BXCL501, Part 2: Matching Placebo, Part 1: Matching Placebo
Schizoaffective Disorder Clinical Trial 2023: BXCL501 Highlights & Side Effects. Trial Name: NCT05658510 — Phase 3
BXCL501 (Alpha-2 Adrenergic Receptor Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05658510 — Phase 3
Schizoaffective Disorder Patient Testimony for trial: Trial Name: NCT05658510 — Phase 3
~109 spots leftby Sep 2025
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