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SERENITY II: Dexmedetomidine in the Treatment of Agitation Associated With Bipolar Disorder

Sponsor
BioXcel Therapeutics Inc (Industry)
Overall Status
Completed
CT.gov ID
NCT04276883
Collaborator
Cognitive Research Corporation (Industry)
378
Enrollment
15
Locations
3
Arms
2.9
Actual Duration (Months)
25.2
Patients Per Site
8.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a definitive study to support the safety and efficacy evaluation of BXCL501 for the acute treatment of agitation in bipolar disorder. The BXCL501-302 study is designed to characterize the efficacy, safety and tolerability of BXCL501 (sublingual film formulation of DEX, HCl) in agitation associated with bipolar disorder.

Condition or Disease Intervention/Treatment Phase
  • 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 stratified by age < 65 and age ≥ 65. Male and female adults with acute agitation associated with bipolar disorder will be enrolled. Eligible subjects (acutely agitated subjects with bipolar disorder, generally hypomanic, manic or mixed episodes) 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
378 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
phase III, randomized, double-blind, placebo-controlledphase 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 Bipolar Disorder
Actual Study Start Date :
Feb 24, 2020
Actual Primary Completion Date :
May 21, 2020
Actual Study Completion Date :
May 21, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Primary End Point [120 minutes]

    Absolute change from baseline in the PEC score at 2 hours

Secondary Outcome Measures

  1. Key Secondary Endpoint [120 minutes]

    Earliest time where an effect on agitation is apparent as measured by change from baseline PEC total score in contrast with placebo

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

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

  2. Patients who have met DSM-5 criteria for bipolar I or II 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:

  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 or other hypnotics or oral or short-acting intramuscular antipsychotic 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 BioXcel Clinical Research Site Little Rock Arkansas United States 72211
2 BioXcel Clinical Research Site Cerritos California United States 90703
3 BioXcel Clinical Research Site Culver City California United States 90230
4 BioXcel Clinical Research Site Long Beach California United States 90806
5 BioXcel Clinical Research Site Orange California United States 92868
6 BioXcel Clinical Research Site Miami Lakes Florida United States 33016
7 BioXcel Clinical Research Site Chicago Illinois United States 60640
8 BioXcel Clinical Research Site Gaithersburg Maryland United States 20877
9 BioXcel Clinical Research Site Las Vegas Nevada United States 89102
10 BioXcel Clinical Research Site Berlin New Jersey United States 08009
11 BioXcel Clinical Research Site Marlton New Jersey United States 08053
12 BioXcel Clinical Research Site Charleston South Carolina United States 29407
13 BioXcel Clinical Research Site Austin Texas United States 78754
14 BioXcel Clinical Research Site DeSoto Texas United States 75115
15 BioXcel Clinical Research Site Richardson Texas United States 75080

Sponsors and Collaborators

  • BioXcel Therapeutics Inc
  • Cognitive Research Corporation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
BioXcel Therapeutics Inc
ClinicalTrials.gov Identifier:
NCT04276883
Other Study ID Numbers:
  • BXCL501-302
First Posted:
Feb 19, 2020
Last Update Posted:
Aug 19, 2020
Last Verified:
Mar 1, 2020
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Psychomotor Agitation
Disease
Bipolar Disorder
Dexmedetomidine

Study Results

No Results Posted as of Aug 19, 2020