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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 who are receiving stable treatment for the last 3 months prior to Screening for the underlying primary diagnosis and who are expected to remain on stable treatment for the duration of the study (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 below
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I have been diagnosed with bipolar disorder, schizophrenia, or a related condition.
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I've been on a steady treatment for my condition for the last 3 months.
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I've needed help for agitation 3 times in the last 3 months.
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I use medication as needed to manage sudden agitation episodes.
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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 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 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

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 more

Side effects data

From 2020 Phase 4 trial • 798 Patients • NCT02004613
57%
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 1: Matching PlaceboPlacebo Group1 Intervention
Sublingual Placebo film
Group IV: Part 2: 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?

Worldwide Clinical TrialsOTHER
60 Previous Clinical Trials
13,937 Total Patients Enrolled
BioXcel Therapeutics IncLead Sponsor
18 Previous Clinical Trials
1,972 Total Patients Enrolled
11 Trials studying Psychomotor Agitation
1,296 Patients Enrolled for Psychomotor Agitation
Robert Risinger, MDStudy ChairBioXcel Therapeutics
10 Previous Clinical Trials
1,372 Total Patients Enrolled
6 Trials studying Psychomotor Agitation
669 Patients Enrolled for Psychomotor Agitation

Media Library

BXCL501 (Alpha-2 Adrenergic Receptor Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT05658510 — Phase 3
Psychomotor Agitation Research Study Groups: Part 2: 80 mcg of BXCL501, Part 1: Matching Placebo, Part 1: 60 mcg of BXCL501, Part 2: Matching Placebo
Psychomotor Agitation 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
Psychomotor Agitation Patient Testimony for trial: Trial Name: NCT05658510 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is eligibility for this clinical trial restricted to individuals over 50 years of age?

"As outlined by the ineligibility parameters, the minimum age requirement to participate is 18 years old, while those aged 75 or older are excluded."

Answered by AI

Are individuals currently able to enrol in this research project?

"Based on clinicaltrials.gov, this trial is currently in search of participants with an initial posting date set at November 21st 2022 and a recent update made on December 12th 2021."

Answered by AI

Has the Food and Drug Administration given authorization to use 60 mcg of BXCL501 in Part 1?

"The safety assessment of 60 mcg BXCL501 has been rated a 3 due to the evidence collected in Phase 3 trials, including data that positively supports its efficacy and multiple rounds verifying its security."

Answered by AI

To what extent is enrollment in this clinical trial being expanded?

"Affirmative. Clinicaltrials.gov records demonstrate that this medical experiment, going live on November 21st 2022, is still recruiting participants. 450 people are needed to join the trial at two different sites."

Answered by AI

Am I eligible to be a part of this experiment?

"This trial is seeking 450 participants who have akathisia, aged between 18 and 75. Additional criteria must be met, such as being able to read and understand written informed consent and having a minimum score of 14 on the Poor Impulse Control Scale (PEC). Additionally, those enrolled in Part 1 require effective birth control use while those enrolling in Part 2 need to meet Diagnostic & Statistical Manual 5/5-Text Revision requirements for bipolar I or II disorder, schizophrenia, schizoaffective or schizophreniform disorders. Furthermore all potential patients are subject to a comprehensive medical history review alongside physical examination, 12-lead ECG testing"

Answered by AI

What is the objective of this clinical experiment?

"According to the study sponsor, BioXcel Therapeutics Inc., their primary outcome is Part 2: Occurrence of treatment-emergent adverse events (TEAEs) over a two hour period. Additionally, they will be measuring secondary outcomes such as Part 1: Shift in Modified Clinical Global Impression - Severity (mCGI-S) scores from baseline, Part 1: Number of responders based on mCGI-S score, and Part1: Change from Baseline in Agitation-Calmness Evaluation Scale (ACES)."

Answered by AI

Who else is applying?

What state do they live in?
Pennsylvania
Texas
Other
California
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
2
1
3+
What site did they apply to?
Bioxcel Clinical Research Site
BioXcel Clinical Research Site
BioXcel Clinical Research Site 125
Other

Why did patients apply to this trial?

No drug seems to bring me down for king. I'm really hoping for a drug that works.
PatientReceived 1 prior treatment
I am up and down seasonally. I need something better. Tired of loisibg love ones, family members because of this condition.
PatientReceived 1 prior treatment
My current medications to treat Schizoaffective Disorder aren't working as well as I had hoped.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

are the compensated ?? Does any of the trial require me to stay overnight?
PatientReceived no prior treatments
What does the study pay and do you provide transportation?
PatientReceived 2+ prior treatments
~193 spots leftby Mar 2025