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Alpha-2 Adrenergic Receptor Agonist
Dexmedetomidine for Agitation in Schizophrenia and Bipolar Disorder
Phase 3
Waitlist Available
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, and 2, 4, 6, and 8 hours postdose
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, and 2, 4, 6, and 8 hours postdose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, and 2, 4, 6, and 8 hours postdose
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Part 1: Change from baseline in Positive and Negative Syndrome Scale - Excited (PEC) total score
Part 2: Incidence of serious adverse events (SAEs)
Part 2: Incidence of treatment-emergent adverse events (TEAEs)
Secondary outcome measures
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
+15 moreSide effects data
From 2020 Phase 4 trial • 798 Patients • NCT0200461357%
Clinically important hypotension
9%
Clinically important bradycardia
1%
infection
1%
stroke
1%
Atelectasis
1%
Hemorrhage
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Dexmedetomidine
Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Part 2: 80 mcg of BXCL501Experimental Treatment1 Intervention
Sublingual film containing 80 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
61 Previous Clinical Trials
13,937 Total Patients Enrolled
Robert Risinger, MDStudy ChairBioXcel Therapeutics
10 Previous Clinical Trials
1,375 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I've been on a steady treatment for my condition for the last 3 months.I've needed help for agitation 3 times in the last 3 months.I use medication as needed to manage sudden agitation episodes.I have a history of fainting or currently have low blood volume or blood pressure issues when standing.I have been diagnosed with bipolar disorder, schizophrenia, or a related condition.You are not showing signs of being very agitated due to being drunk or using drugs, except for THC.I am not taking medications like terazosin, doxazosin, or similar drugs.I haven't taken any sedatives or antipsychotic drugs in the 4 hours before the study treatment.My overall health is good as confirmed by various medical tests.I needed help for agitation in the last month.I haven't taken any sedatives or antipsychotic drugs in the 4 hours before treatment.I am between 18 and 75 years old.You have a high score on a specific test called the PEC at the beginning of the study.I have previously taken IGALMI™ or participated in a trial for BXCL501.You were diagnosed with certain personality disorders before being diagnosed with schizophrenia or bipolar disorder.You are considered to be very agitated based on a set of questions about your behavior and emotions.I am not pregnant or breastfeeding.I have been diagnosed with bipolar disorder, schizophrenia, or a related condition.I have a history of serious brain or neurological conditions.I do not have any serious or unstable illnesses.You are considered to be at high risk of harming yourself.You have a history of getting very upset because of using drugs or alcohol.You have abnormal test results that are important to your doctor.You have already participated in a clinical trial involving BXCL501 (Part 1 only).You are not currently showing aggressive behavior due to being intoxicated with alcohol or drugs, except for THC.
Research Study Groups:
This trial has the following groups:- Group 1: Part 1: 60 mcg of BXCL501
- Group 2: Part 2: 80 mcg of BXCL501
- Group 3: Part 2: Matching Placebo
- Group 4: Part 1: Matching Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Schizophreniform Disorder Patient Testimony for trial: Trial Name: NCT05658510 — Phase 3
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