search
Back to results

Safety and Tolerability of Open-Label Flexible-dose Brexpiprazole as Maintenance Treatment in Adolescents With Schizophrenia

Primary Purpose

Schizophrenia

Status
Active
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Brexpiprazole
Sponsored by
Otsuka Pharmaceutical Development & Commercialization, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Schizophrenia focused on measuring Brexpiprazole, Schizophrenia

Eligibility Criteria

13 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male & female subjects 13-17 years of age, inclusive.
  • Subjects who turn 18 during trial 331-10-234 are permitted in this trial.
  • Subjects with a current primary diagnosis of schizophrenia, as defined by Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria and confirmed by the K-SADS-PL completed at time of entry into Trial 331-10-234. For de novo subjects who did not participate in Trial 331-10-234, the initial diagnosis of schizophrenia must be made and documented, and the diagnosis confirmed by the K-SADS-PL at screening.
  • Subjects who, in the investigator's judgment, require treatment with antipsychotic medication(s).

Exclusion Criteria:

  • Subjects with a DSM-5 diagnosis other than schizophrenia that has been the primary focus of treatment within 3 months of screening
  • Subjects with a clinical presentation or history that is consistent with delirium, dementia, amnesia, or other cognitive disorders; subjects with psychotic symptoms that are better accounted for by another general medical condition(s) or direct effect of a substance (e.g., medication, illicit drug use).
  • History of failure of clozapine treatment or response to clozapine treatment only.
  • History of neuroleptic malignant syndrome

Sites / Locations

  • For additional information regarding sites, contact 844-687-8522

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Rollover & De-Novo

Arm Description

1-4 mg/day; Start at 0.5 mg/day, titrate and maintain between 1mg/day to max of 4 mg/day

Outcomes

Primary Outcome Measures

Frequency & Severity of Adverse Events (AE) [Safety]
Frequency and severity will be monitored; along with serious AEs & discontinuation from trial due to AE

Secondary Outcome Measures

Mean change from baseline and incidence of clinically significant abnormalities in clinical laboratory tests [Safety]
Abnormalities in hematology, serum chemistry [including fasting blood lipids, glucose and insulin, serum prolactin], glycosylated hemoglobin [HbA1c], creatine phosphokinase [CPK] and urinalysis) results
Mean change from baseline and incidence of clinically significant abnormalities in vital signs [Safety]
Mean change from baseline in supine and standing positions will be assessed and incidence of clinically significant abnormalities
Weight [Safety]
Change in weight, in kilograms, will be assessed for any notable differences from baseline
Height [Safety]
Change in height, in centimeters, will be assessed for any notable differences from baseline
Body Mass Index (BMI) [Safety]
Measured in kilograms/meter^2 and assessed to determine any notable differences from baseline
Waist Circumference [Safety]
Change in waist circumference, in centimeters will be assessed for any notable differences from baseline
Changes in ECG [Safety]
Mean change from baseline will be assessed and incidence of clinically significant abnormalities
Change in Abnormal Involuntary Movement Scale (AIMS) Score [Safety]
Mean change from baseline will be assessed
Change in Simpson-Angus Scale (SAS) Score [Safety]
Mean change from baseline will be assessed
Change in Barnes Akathisia Rating Scale (BARS) Score [Safety]
Mean change from baseline will be assessed
Potential suicide events recorded on the Columbia-Suicide Severity Rating Scale (C-SSRS) [Safety]
Analysis of potential suicide events recorded with C SSRS
Comprehensive psychotropic side effects as assessed by Udvalg for Kliniske Undersogelser (UKU) [Safety]
Psychotropic side effects will be assessed by UKU
The frequency of symptom items from New York Assessment for Adverse Cognitive Effects of Neuropsychiatric Treatment (NY-AACENT) [Safety]
Frequency of symptom items will be assessed
Change in Tanner Staging Scale Scores [Safety]
Baseline and post-baseline data will be assessed
Time to discontinuation due to AE
Time to discontinue will be assessed as applicable
Change in the Positive and Negative Syndrome Scale (PANSS) Total Score and PANSS Subscale Scores
Change from baseline in total score will be assessed for efficacy of drug. Positive/Negative subscale scores will be assessed for efficacy of drug.
Change in Children's Global Assessment Scale (CGAS) Score
Change from baseline in CGAS will be assessed for efficacy of drug
Change in Clinical Global Impression Severity (CGI-S) Score
Change in Clinical Global Impression Improvement (CGI-I) Score

Full Information

First Posted
August 1, 2017
Last Updated
August 2, 2023
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators
H. Lundbeck A/S
search

1. Study Identification

Unique Protocol Identification Number
NCT03238326
Brief Title
Safety and Tolerability of Open-Label Flexible-dose Brexpiprazole as Maintenance Treatment in Adolescents With Schizophrenia
Official Title
A Long-term, Multicenter, Open-label Trial to Evaluate the Safety and Tolerability of Flexible-Dose Brexpiprazole as Maintenance Treatment in Adolescents (13-17 Years Old) With Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 23, 2017 (Actual)
Primary Completion Date
May 2025 (Anticipated)
Study Completion Date
May 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators
H. Lundbeck A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To further characterize the long-term safety and tolerability of brexpiprazole in adolescents with schizophrenia
Detailed Description
This is a long-term, multicenter, open-label trial designed to examine the long-term safety and tolerability of brexpiprazole in adolescent subjects (ages 13-17) with a DSM-5 diagnosis of schizophrenia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Brexpiprazole, Schizophrenia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
296 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rollover & De-Novo
Arm Type
Experimental
Arm Description
1-4 mg/day; Start at 0.5 mg/day, titrate and maintain between 1mg/day to max of 4 mg/day
Intervention Type
Drug
Intervention Name(s)
Brexpiprazole
Other Intervention Name(s)
OPC-34712
Intervention Description
Once daily, oral tablets
Primary Outcome Measure Information:
Title
Frequency & Severity of Adverse Events (AE) [Safety]
Description
Frequency and severity will be monitored; along with serious AEs & discontinuation from trial due to AE
Time Frame
Up to 24 months or early termination with a 21 day follow-up period
Secondary Outcome Measure Information:
Title
Mean change from baseline and incidence of clinically significant abnormalities in clinical laboratory tests [Safety]
Description
Abnormalities in hematology, serum chemistry [including fasting blood lipids, glucose and insulin, serum prolactin], glycosylated hemoglobin [HbA1c], creatine phosphokinase [CPK] and urinalysis) results
Time Frame
Up to 24 months or early termination
Title
Mean change from baseline and incidence of clinically significant abnormalities in vital signs [Safety]
Description
Mean change from baseline in supine and standing positions will be assessed and incidence of clinically significant abnormalities
Time Frame
Up to 24 months or early termination with a 21 day follow-up period
Title
Weight [Safety]
Description
Change in weight, in kilograms, will be assessed for any notable differences from baseline
Time Frame
Up to 24 months or early termination
Title
Height [Safety]
Description
Change in height, in centimeters, will be assessed for any notable differences from baseline
Time Frame
Up to 24 months or early termination
Title
Body Mass Index (BMI) [Safety]
Description
Measured in kilograms/meter^2 and assessed to determine any notable differences from baseline
Time Frame
Up to 24 months or early termination
Title
Waist Circumference [Safety]
Description
Change in waist circumference, in centimeters will be assessed for any notable differences from baseline
Time Frame
Up to 24 months or early termination
Title
Changes in ECG [Safety]
Description
Mean change from baseline will be assessed and incidence of clinically significant abnormalities
Time Frame
Up to 24 months or early termination
Title
Change in Abnormal Involuntary Movement Scale (AIMS) Score [Safety]
Description
Mean change from baseline will be assessed
Time Frame
Up to 24 months or early termination
Title
Change in Simpson-Angus Scale (SAS) Score [Safety]
Description
Mean change from baseline will be assessed
Time Frame
Up to 24 months or early termination
Title
Change in Barnes Akathisia Rating Scale (BARS) Score [Safety]
Description
Mean change from baseline will be assessed
Time Frame
Up to 24 months or early termination
Title
Potential suicide events recorded on the Columbia-Suicide Severity Rating Scale (C-SSRS) [Safety]
Description
Analysis of potential suicide events recorded with C SSRS
Time Frame
Up to 24 months or early termination
Title
Comprehensive psychotropic side effects as assessed by Udvalg for Kliniske Undersogelser (UKU) [Safety]
Description
Psychotropic side effects will be assessed by UKU
Time Frame
Up to 24 months or early termination
Title
The frequency of symptom items from New York Assessment for Adverse Cognitive Effects of Neuropsychiatric Treatment (NY-AACENT) [Safety]
Description
Frequency of symptom items will be assessed
Time Frame
Up to 24 months or early termination
Title
Change in Tanner Staging Scale Scores [Safety]
Description
Baseline and post-baseline data will be assessed
Time Frame
Up to 24 months or early termination
Title
Time to discontinuation due to AE
Description
Time to discontinue will be assessed as applicable
Time Frame
Up to 24 months or early termination
Title
Change in the Positive and Negative Syndrome Scale (PANSS) Total Score and PANSS Subscale Scores
Description
Change from baseline in total score will be assessed for efficacy of drug. Positive/Negative subscale scores will be assessed for efficacy of drug.
Time Frame
Up to 24 months or early termination
Title
Change in Children's Global Assessment Scale (CGAS) Score
Description
Change from baseline in CGAS will be assessed for efficacy of drug
Time Frame
Up to 24 months or early termination
Title
Change in Clinical Global Impression Severity (CGI-S) Score
Time Frame
Up to 24 months or early termination
Title
Change in Clinical Global Impression Improvement (CGI-I) Score
Time Frame
Up to 24 months or early termination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male & female subjects 13-17 years of age, inclusive. Subjects who turn 18 during trial 331-10-234 are permitted in this trial. Subjects with a current primary diagnosis of schizophrenia, as defined by Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria and confirmed by the K-SADS-PL completed at time of entry into Trial 331-10-234. For de novo subjects who did not participate in Trial 331-10-234, the initial diagnosis of schizophrenia must be made and documented, and the diagnosis confirmed by the K-SADS-PL at screening. Subjects who, in the investigator's judgment, require treatment with antipsychotic medication(s). Exclusion Criteria: Subjects with a DSM-5 diagnosis other than schizophrenia that has been the primary focus of treatment within 3 months of screening Subjects with a clinical presentation or history that is consistent with delirium, dementia, amnesia, or other cognitive disorders; subjects with psychotic symptoms that are better accounted for by another general medical condition(s) or direct effect of a substance (e.g., medication, illicit drug use). History of failure of clozapine treatment or response to clozapine treatment only. History of neuroleptic malignant syndrome
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuko Hirata, MD, PhD
Organizational Affiliation
Otsuka Pharmaceutical Development & Commercialization, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
For additional information regarding sites, contact 844-687-8522
City
Kinston
State/Province
North Carolina
ZIP/Postal Code
28501
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Safety and Tolerability of Open-Label Flexible-dose Brexpiprazole as Maintenance Treatment in Adolescents With Schizophrenia

We'll reach out to this number within 24 hrs