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A Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Subjects With Bipolar I Disorder

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03287869
Recruitment Status : Completed
First Posted : September 19, 2017
Last Update Posted : May 1, 2020
Sponsor:
Collaborator:
H. Lundbeck A/S
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.

Tracking Information
First Submitted Date  ICMJE August 24, 2017
First Posted Date  ICMJE September 19, 2017
Last Update Posted Date May 1, 2020
Actual Study Start Date  ICMJE October 24, 2017
Actual Primary Completion Date July 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 15, 2017)
Frequency and severity of Adverse Events (AEs) [Safety & Tolerability] [ Time Frame: Up to 26 weeks or early termination with a 21 day follow-up period ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: September 15, 2017)
  • Change from baseline in Young-Mania Rating Scale (YMRS) Total Score [Efficacy] [ Time Frame: Up to 26 weeks or early termination ]
  • Change from baseline in Clinical Global Impression-Bipolar (CGI-BP) Severity Score [Efficacy] [ Time Frame: Up to 26 weeks or early termination ]
  • Mean CGI-BP score change from preceding phase score in mania [Efficacy] [ Time Frame: Up to 26 weeks or early termination ]
  • Change from baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score [Efficacy] [ Time Frame: Up to 26 weeks or early termination ]
  • Change from baseline in Global Assessment of Functioning (GAF) Score [Efficacy] [ Time Frame: Up to 26 weeks or early termination ]
  • YMRS remission rate [Efficacy] [ Time Frame: Up to 26 weeks or early termination ]
    Remission defined as YMRS total score less than or equal to 12 and MADRS total score less than or equal to 12 at each visit
  • Stabilization rate at each visit [Efficacy] [ Time Frame: Up to 26 weeks or early termination ]
    Stabilization is defined as: Outpatient status, YMRS total score less than or equal to 12, MADRS total score less than or equal to 12, & no active suicidality (active suicidality defined as a score of 4 or more on the MADRS item 10 OR answer of "yes" on questions 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS))
  • Discontinuation rate for lack of efficacy [Efficacy] [ Time Frame: Up to 26 weeks or early termination ]
  • Analysis of data collected from a subject wearable device [Efficacy] [ Time Frame: Up to 26 weeks or early termination ]
    Collects data on subject activity. Will be monitored for abnormal changes from baseline
  • Clinical laboratory tests [Safety] [ Time Frame: Up to 26 weeks or early termination ]
    hematology, serum chemistry, coagulation parameters & urinalysis will be assessed to determine the safety and tolerability of drug
  • Physical Examinations [Safety] [ Time Frame: Up to 26 weeks or early termination ]
    Will be assessed for abnormal changes from baseline
  • Vital sign measurements [Safety] [ Time Frame: Up to 26 weeks or early termination ]
    Will be monitored for abnormal changes from baseline
  • Electrocardiograms (ECG) [Safety] [ Time Frame: Up to 26 weeks or early termination ]
    Will be monitored for abnormal changes from baseline
  • Body weight [Safety] [ Time Frame: Up to 26 weeks or early termination ]
    Will be measured in kilograms and monitored for changes from baseline
  • Height [Safety] [ Time Frame: Up to 26 weeks or early termination ]
    Will be measured in centimeters, and monitored for changes from baseline
  • Waist Circumference [Safety] [ Time Frame: Up to 26 weeks or early termination ]
    Will be measured in centimeters, and monitored for changes from baseline
  • Simpson-Angus Scale (SAS) Score [Safety] [ Time Frame: Up to 26 weeks or early termination ]
    To be used in assessing extrapyramidal symptoms (EPS) by evaluating mean change from baseline
  • Abnormal Involuntary Movement Scale (AIMS) Score [Safety] [ Time Frame: Up to 26 weeks or early termination ]
    To be used in assessing extrapyramidal symptoms (EPS) by evaluating mean change from baseline
  • Barnes Akathisia Rating Scale (BARS) Score [ Time Frame: Up to 26 weeks or early termination ]
    To be used in assessing extrapyramidal symptoms (EPS) by evaluating mean change from baseline
  • C-SSRS [Safety] [ Time Frame: Up to 26 weeks or early termination ]
    Utilized to assess and classify reported suicidal behavior
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE A Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Subjects With Bipolar I Disorder
Official Title  ICMJE A Multicenter, Open-label Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Subjects With Bipolar I Disorder
Brief Summary This study will evaluate the safety and tolerability of brexpiprazole (OPC-34712) in the treatment of subjects with bipolar I disorder. All subjects will receive a starting dose of brexpiprazole which will be titrated up in subsequent visits.
Detailed Description While the availability of atypical antipsychotics have increased the therapeutic options available, there remains a need for safer and more effective therapies in the treatment of manic and depressive episodes of bipolar I disorder. Brexpiprazole's specific receptor activity profile likely correlates with its established efficacy in schizophrenia and major depressive disorder, and may prove to be an effective target for the treatment of acute mania of bipolar I disorder.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Group composed of eligible rollover subjects who completed one of the double-blind, phase 3 efficacy trials (331-201-00080 or 331-201-00081). In the event the sponsor determines that the enrollment rate of rollover subjects will not be sufficient to meet the target completion, de novo subjects may be enrolled at select sites. The enrollment of de novo subjects at any site will not be permitted until initiation and notification by the sponsor.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Bipolar I Disorder
  • Acute Mania
Intervention  ICMJE Drug: Brexpiprazole
Brexpiprazole tablet
Study Arms  ICMJE Experimental: Brexpiprazole
Oral, tablet; starting dose of 2 mg/day, with potential to be titrated to a max of 4 mg/day
Intervention: Drug: Brexpiprazole
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 15, 2017)
384
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 31, 2019
Actual Primary Completion Date July 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria (rollover subjects from 331-201-00080 & 331-201-00081 trials)

  • Subjects remaining in hospital at the day 21 visit of trial 331-201-00080 or 331-201-00081 will be permitted to enroll in the 331-201-00083 trial at the week 3 visit of the double-blind trial if they are planned to be discharged from the hospital before the week 1 visit of trial 331-201-0083. Subjects not discharged by the week 1 visit of trial 331-201-0083 must be withdrawn.
  • Subjects who, in the opinion of the investigator, could potentially benefit from administration of oral brexpiprazole for the treatment of bipolar I disorder and who completed 3 weeks of post-randomization treatment in Trial 331-201-00080 & Trial 331-201-00081

Exclusion Criteria (rollover subjects from 331-201-00080 & 331-201-00081 trials)

  • Subjects with a major protocol violation during the course of their participation in the double-blind phase 3 trials (331-201-00080 or 331-201-00081).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Bulgaria,   Croatia,   Poland,   Serbia,   Ukraine,   United States
Removed Location Countries Romania
 
Administrative Information
NCT Number  ICMJE NCT03287869
Other Study ID Numbers  ICMJE 331-201-00083
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Sponsor  ICMJE Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators  ICMJE H. Lundbeck A/S
Investigators  ICMJE Not Provided
PRS Account Otsuka Pharmaceutical Development & Commercialization, Inc.
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP