Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Dexmedetomidine in the Treatment of Agitation Associated With Schizophrenia (SERENITY I)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04268303
Recruitment Status : Recruiting
First Posted : February 13, 2020
Last Update Posted : March 20, 2020
Sponsor:
Collaborator:
Cognitive Research Corporation
Information provided by (Responsible Party):
BioXcel Therapeutics Inc

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.

Condition or disease Intervention/treatment Phase
Agitation Schizophrenia Schizo Affective Disorder Schizoaffective Disorder Schizophreniform Disorders Drug: Sublingual film containing dexmedetomidine (BXCL501) Drug: Placebo Film Phase 3

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 375 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Phase III, Randomized, Double-Blind, Placebo-Controlled
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double-Blind, Placebo-Controlled
Primary Purpose: Treatment
Official Title: A Phase III Multicenter, Randomized, Double-Blind, Placebo-Controlled Study To Determine Efficacy and Safety of BXCL501 In Agitation Associated With Schizophrenia
Actual Study Start Date : January 24, 2020
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : May 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: 120 Micrograms
Sublingual film containing 120 Micrograms dexmedetomidine
Drug: Sublingual film containing dexmedetomidine (BXCL501)
Sublingual film containing dexmedetomidine (BXCL501)

Experimental: 180 Micrograms
Sublingual film containing 180 Micrograms dexmedetomidine
Drug: Sublingual film containing dexmedetomidine (BXCL501)
Sublingual film containing dexmedetomidine (BXCL501)

Placebo Comparator: Placebo
Sublingual placebo film
Drug: Placebo Film
Placebo Film for BXCL501




Primary Outcome Measures :
  1. Primary End Point [ Time Frame: 120 minutes ]
    Absolute change from baseline in the PEC total score at 2 hours


Secondary Outcome Measures :
  1. key Secondary Endpoint [ Time Frame: 120 minutes ]
    Earliest time where an effect on agitation is apparent as measured by change from baseline PEC total score in contrast with placebo



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04268303


Contacts
Layout table for location contacts
Contact: Andressa de Oliveira 475-238-6837 adoliveira@bioxceltherapeutics.com
Contact: Cedric Burg 475-238-6837 cburg@bioxceltherapeutics.com

Locations
Layout table for location information
United States, Arkansas
BioXcel Clinical Research Site Recruiting
Little Rock, Arkansas, United States, 72211
Contact: BioXcel CTM    475-238-6837    info@bioxceltherapeutics.com   
United States, California
BioXcel Clinical Research Site Recruiting
Cerritos, California, United States, 78754
Contact: BioXcel CTM    475-238-6837    info@bioxceltherapeutics.com   
BioXcel Clinical Research Site Recruiting
Culver City, California, United States, 90230
Contact: BioXcel CTM    475-238-6837    info@bioxceltherapeutics.com   
BioXcel Clinical Research Site Recruiting
Long Beach, California, United States, 90806
Contact: BioXcel CTM    475-238-6837    info@bioxceltherapeutics.com   
BioXcel Clinical Research Site Recruiting
Orange, California, United States, 92868
Contact: BioXcel CTM    475-238-6837    info@bioxceltherapeutics.com   
United States, Florida
BioXcel Clinical Research Site Recruiting
Miami Lakes, Florida, United States, 33016
Contact: BioXcel CTM    475-238-6837    info@bioxceltherapeutics.com   
United States, Illinois
BioXcel Clinical Research Site Recruiting
Chicago, Illinois, United States, 60640
Contact: BioXcel CTM    475-238-6837    info@bioxceltherapeutics.com   
United States, Maryland
BioXcel Clinical Research Site Recruiting
Gaithersburg, Maryland, United States, 20877
Contact: BioXcel CTM    475-238-6837    info@bioxceltherapeutics.com   
United States, Nevada
BioXcel Clinical Research Site Recruiting
Las Vegas, Nevada, United States, 89102
Contact: BioXcel CTM    475-238-6837    info@bioxceltherapeutics.com   
United States, New Jersey
BioXcel Clinical Research Site Recruiting
Berlin, New Jersey, United States, 08009
Contact: BioXcel CTM    475-238-6837    info@bioxceltherapeutics.com   
BioXcel Clinical Research Site Recruiting
Marlton, New Jersey, United States, 08053
Contact: BioXcel CTM    475-238-6837    info@bioxceltherapeutics.com   
United States, South Carolina
BioXcel Clinical Research Site Recruiting
Charleston, South Carolina, United States, 29407
Contact: BioXcel CTM    475-238-6837    info@bioxceltherapeutics.com   
United States, Texas
BioXcel Clinical Research Site Recruiting
Austin, Texas, United States, 78754
Contact: BioXcel CTM    475-238-6837    info@bioxceltherapeutics.com   
BioXcel Clinical Research Site Recruiting
DeSoto, Texas, United States, 75115
Contact: BioXcel CTM    475-238-6837    info@bioxceltherapeutics.com   
BioXcel Clinical Research Site Recruiting
Richardson, Texas, United States, 75080
Contact: BioXcel CTM    475-238-6837    info@bioxceltherapeutics.com   
Sponsors and Collaborators
BioXcel Therapeutics Inc
Cognitive Research Corporation
Layout table for additonal information
Responsible Party: BioXcel Therapeutics Inc
ClinicalTrials.gov Identifier: NCT04268303    
Other Study ID Numbers: BXCL501-301
First Posted: February 13, 2020    Key Record Dates
Last Update Posted: March 20, 2020
Last Verified: March 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Psychomotor Agitation
Disease
Schizophrenia
Psychotic Disorders
Mood Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action