Dexmedetomidine in the Treatment of Agitation Associated With Schizophrenia

NCT ID: NCT04268303

Last Updated: 2023-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 380 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-24
• Study Completion Date: 2020-05-06

Brief Summary

This is a definitive study to support the safety and efficacy evaluation of BXCL501 for the acute treatment of agitation in schizophrenia. The BXCL501-301 study is designed to characterize the efficacy, safety and tolerability of BXCL501 (sublingual film formulation of DEX, HCl) in agitation associated with schizophrenia, schizoaffective disorder or schizophreniform disorder.

Detailed Description

The study will enroll approximately 375 subjects randomized 1:1:1 to dose regimens of 180µg, 120µg BXCL501, or placebo. Male and female adults with acute agitation associated with schizophrenia, schizoaffective disorder, or schizophreniform disorder will be enrolled. Eligible subjects may be identified in outpatient clinics, mental health, psychiatric or medical emergency services including medical/psychiatric observation units, or as newly admitted to a hospital setting for acute agitation or already in hospital for chronic underlying conditions. Subjects will be domiciled in a clinical research setting or hospitalized to remain under medical supervision while undergoing screening procedures to assess eligibility. Efficacy and safety assessments will be conducted periodically before and after dosing.

Conditions

Agitation; Schizophrenia; Schizo Affective Disorder; Schizoaffective Disorder; Schizophreniform Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

120 Micrograms

Sublingual film containing 120 Micrograms dexmedetomidine

Group Type: EXPERIMENTAL

Sublingual film containing dexmedetomidine (BXCL501)

Intervention Type: DRUG

Sublingual film containing dexmedetomidine (BXCL501)

180 Micrograms

Sublingual film containing 180 Micrograms dexmedetomidine

Group Type: EXPERIMENTAL

Sublingual film containing dexmedetomidine (BXCL501)

Intervention Type: DRUG

Sublingual film containing dexmedetomidine (BXCL501)

Placebo

Sublingual placebo film

Group Type: PLACEBO_COMPARATOR

Placebo Film

Intervention Type: DRUG

Placebo Film for BXCL501

Interventions

Sublingual film containing dexmedetomidine (BXCL501)

Sublingual film containing dexmedetomidine (BXCL501)

Intervention Type: DRUG

Placebo Film

Placebo Film for BXCL501

Intervention Type: DRUG

Other Intervention Names

Dexmedetomidine; Placebo

Eligibility Criteria

Inclusion Criteria

A subject will be eligible for inclusion in the study if he or she meets the following criteria:

1. Male and female patients between the ages of 18 to 75 years, inclusive.

2. Patients who have met DSM-5 criteria for schizophrenia, schizoaffective, or schizophreniform disorder.

3. Patients who are judged to be clinically agitated at Screening and Baseline with a total score of ≥ 14 on the 5 items (poor impulse control, tension, hostility, uncooperativeness, and excitement) comprising the PANSS Excited Component (PEC).

4. Patients who have a score of ≥ 4 on at least 1 of the 5 items on the PEC at Baseline.

5. Patients who read, understand, and provide written informed consent.

6. Patients who are in good general health prior to study participation as determined by a detailed medical history, physical examination, 12-lead ECG with rhythm strip, blood chemistry profile, hematology, urinalysis, and in the opinion of the Principal Investigator.

7. Participants who agree to use a medically acceptable and effective birth control method

Exclusion Criteria

A subject will be excluded from the study if he or she meets the following criteria:

1. Patients with agitation caused by acute intoxication, including positive identification of alcohol by breathalyzer or drugs of abuse (with the exception of THC) during urine screening.

2. Use of benzodiazepines, hypnotics and anti-psychotic drugs in the 4 hours before study treatment.

3. Treatment with alpha-1 noradrenergic blockers (terazosin, doxazosin, tamsulosin, alfuzosin, or prazosin) or other prohibited medications.

4. Patients who are judged to be at significant risk of suicide

5. Female patients who have a positive pregnancy test at screening or are breastfeeding.

6. Patients who have hydrocephalus, seizure disorder, or history of significant head trauma, stroke, transient ischemic attack, subarachnoid bleeding, brain tumor, encephalopathy, meningitis, Parkinson's disease or focal neurological findings.

7. History of syncope or other syncopal attacks, current evidence of hypovolemia, orthostatic hypotension.

8. Patients with laboratory or ECG abnormalities considered clinically significant by the investigator.

9. Patients with serious or unstable medical illnesses.

10. Patients who have received an investigational drug within 30 days prior to the current agitation episode.

11. Patients who are considered by the investigator, for any reason, to be an unsuitable candidate for receiving DEX.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cognitive Research Corporation

INDUSTRY

Sponsor Role: collaborator

BioXcel Therapeutics Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Risinger, MD

Role: STUDY_CHAIR

BioXcel Therapeutics

Locations

BioXcel Clinical Research Site

Little Rock, Arkansas, United States

BioXcel Clinical Research Site

Cerritos, California, United States

BioXcel Clinical Research Site

Culver City, California, United States

BioXcel Clinical Research Site

Long Beach, California, United States

BioXcel Clinical Research Site

Orange, California, United States

BioXcel Clinical Research Site

Miami Lakes, Florida, United States

BioXcel Clinical Research Site

Chicago, Illinois, United States

BioXcel Clinical Research Site

Gaithersburg, Maryland, United States

BioXcel Clinical Research Site

Las Vegas, Nevada, United States

BioXcel Clinical Research Site

Berlin, New Jersey, United States

BioXcel Clinical Research Site

Marlton, New Jersey, United States

BioXcel Clinical Research Site

Charleston, South Carolina, United States

BioXcel Clinical Research Site

Austin, Texas, United States

BioXcel Clinical Research Site

DeSoto, Texas, United States

BioXcel Clinical Research Site

Richardson, Texas, United States

Countries

United States

References

Citrome L, Preskorn SH, Lauriello J, Krystal JH, Kakar R, Finman J, De Vivo M, Yocca FD, Risinger R, Rajachandran L. Sublingual Dexmedetomidine for the Treatment of Acute Agitation in Adults With Schizophrenia or Schizoaffective Disorder: A Randomized Placebo-Controlled Trial. J Clin Psychiatry. 2022 Oct 3;83(6):22m14447. doi: 10.4088/JCP.22m14447.

Reference Type: DERIVED

PMID: 36198061 (View on PubMed)

Citrome L, Risinger R, Rajachandran L, Robison H. Sublingual Dexmedetomidine for Agitation Associated with Schizophrenia or Bipolar Disorder: A Post Hoc Analysis of Number Needed to Treat, Number Needed to Harm, and Likelihood to be Helped or Harmed. Adv Ther. 2022 Oct;39(10):4821-4835. doi: 10.1007/s12325-022-02274-3. Epub 2022 Aug 24.

Reference Type: DERIVED

PMID: 36002761 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://www.psychiatrist.com/jcp/schizophrenia/sublingual-dexmedetomidine-for-agitation-schizophrenia/

Journal Article

Other Identifiers

BXCL501-301

Identifier Type: -

Identifier Source: org_study_id