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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 : Active, not recruiting
First Posted : September 19, 2017
Last Update Posted : April 12, 2019
Sponsor:
Collaborator:
H. Lundbeck A/S
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.

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.

Condition or disease Intervention/treatment Phase
Bipolar I Disorder Acute Mania Drug: Brexpiprazole Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 384 participants
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
Official Title: A Multicenter, Open-label Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Subjects With Bipolar I Disorder
Actual Study Start Date : October 24, 2017
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Brexpiprazole
Oral, tablet; starting dose of 2 mg/day, with potential to be titrated to a max of 4 mg/day
Drug: Brexpiprazole
Brexpiprazole tablet




Primary Outcome Measures :
  1. 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 ]

Other Outcome Measures:
  1. Change from baseline in Young-Mania Rating Scale (YMRS) Total Score [Efficacy] [ Time Frame: Up to 26 weeks or early termination ]
  2. Change from baseline in Clinical Global Impression-Bipolar (CGI-BP) Severity Score [Efficacy] [ Time Frame: Up to 26 weeks or early termination ]
  3. Mean CGI-BP score change from preceding phase score in mania [Efficacy] [ Time Frame: Up to 26 weeks or early termination ]
  4. Change from baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score [Efficacy] [ Time Frame: Up to 26 weeks or early termination ]
  5. Change from baseline in Global Assessment of Functioning (GAF) Score [Efficacy] [ Time Frame: Up to 26 weeks or early termination ]
  6. 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

  7. 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))

  8. Discontinuation rate for lack of efficacy [Efficacy] [ Time Frame: Up to 26 weeks or early termination ]
  9. 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

  10. 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

  11. Physical Examinations [Safety] [ Time Frame: Up to 26 weeks or early termination ]
    Will be assessed for abnormal changes from baseline

  12. Vital sign measurements [Safety] [ Time Frame: Up to 26 weeks or early termination ]
    Will be monitored for abnormal changes from baseline

  13. Electrocardiograms (ECG) [Safety] [ Time Frame: Up to 26 weeks or early termination ]
    Will be monitored for abnormal changes from baseline

  14. Body weight [Safety] [ Time Frame: Up to 26 weeks or early termination ]
    Will be measured in kilograms and monitored for changes from baseline

  15. Height [Safety] [ Time Frame: Up to 26 weeks or early termination ]
    Will be measured in centimeters, and monitored for changes from baseline

  16. Waist Circumference [Safety] [ Time Frame: Up to 26 weeks or early termination ]
    Will be measured in centimeters, and monitored for changes from baseline

  17. 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

  18. 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

  19. 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

  20. C-SSRS [Safety] [ Time Frame: Up to 26 weeks or early termination ]
    Utilized to assess and classify reported suicidal behavior



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

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): NCT03287869


  Show 73 Study Locations
Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
H. Lundbeck A/S

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Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT03287869     History of Changes
Other Study ID Numbers: 331-201-00083
First Posted: September 19, 2017    Key Record Dates
Last Update Posted: April 12, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:
Bipolar
Mania
Brexpiprazole

Additional relevant MeSH terms:
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Disease
Pathologic Processes
Brexpiprazole
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Dopamine Agonists
Dopamine Agents