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A Long-term Administration Trial of Brexpiprazole Once-weekly (QW) Formulation in Patients With Schizophrenia

Primary Purpose

Schizophrenia

Status
Recruiting
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
OPC-34712FUM/ Brexpiprazole fumarate
Sponsored by
Otsuka Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

New Subjects

Screening period:

  • Patients who are able to provide written informed consent prior to initiation of any protocol-related procedures
  • Patients at least 18 years of age and below the age of 75 at the time of informed consent
  • Patients with a diagnosis of schizophrenia based on DSM-5® at the time of informed consent
  • Patients who are receiving treatment with antipsychotics (other than clozapine), who are considered to require maintenance therapy using antipsychotics, and for whom monotherapy with the brexpiprazole QW formulation and outpatient management are considered feasible. Hospitalization for washout from any previously used drugs specified as prohibited concomitant drugs or hospitalization for symptom management immediately after the start of IMP administration will be allowed at the discretion of the investigator. Hospitalization for social reasons (eg, homelessness or need for shelter that is unrelated to the patient's psychological condition) is permitted. Period 1:
  • Patients for whom switching to monotherapy with the brexpiprazole QW formulation using an add-on and taper-off method within 4 weeks is considered feasible

Period 2:

  • Patients who are able to begin monotherapy with the brexpiprazole QW formulation (at an initial dose of 48 mg/week) Rollover Subjects
  • Patients who are able to provide written informed consent prior to initiation of any protocol-related procedures
  • Patients who have completed the 6-week double-blind treatment period in Trial 331-102-00062
  • Patients for whom monotherapy with the brexpiprazole QW formulation and outpatient management are considered feasible. Hospitalization for symptom management immediately after the start of IMP administration will be allowed at the discretion of the investigator. Hospitalization for social reasons (eg, homelessness or need for shelter that is unrelated to the patient's psychological condition) is permitted.

"Exclusion Criteria: New Subjects

  • Patients who are considered resistant/refractory to antipsychotic treatment Patients
  • Patients who have a history of treatment with clozapine for schizophrenia
  • Patients experiencing acute depressive symptoms within 30 days prior to informed consent that, in the judgment of the investigator, require treatment with an antidepressant
  • Patients who fall under any of the following criteria regarding suicidal ideation and suicidal behavior a)

    • Patients who answered "yes" to Question 4 "Active Suicidal Ideation with Some Intent to Act, without Specific Plan" or Question 5 "Active Suicidal Ideation with Specific Plan and Intent" regarding Columbia-Suicide Severity Rating Scale (C-SSRS) suicidal ideation at screening (for the past 6 months) or at baseline (since the last assessment)
    • Patients who exhibited suicidal behavior on C-SSRS at screening (for the past 2 years) or at baseline (since the last assessment)
    • Patients who present a serious risk of suicide based on the judgment of the investigator
  • Patients presenting tardive dyskinesia at the time of informed consent, as determined by a score of 3 (moderate) or 4 (severe) for Item 8 (severity of abnormal movements) of the Abnormal Involuntary Movement Scale (AIMS) at screening or at baseline
  • Patients with a score of 5 (severe akathisia) in the Barnes Akathisia Rating Scale (BARS) global clinical assessment of akathisia at screening or at baseline
  • Patients with a diagnosis of a concurrent mental disorder besides schizophrenia (schizoaffective disorder, major depressive disorder, bipolar I disorder, bipolar II disorder, general anxiety disorder, obsessive-compulsive disorder, post-traumatic stress disorder, dementia or mild neurocognitive disorder, personality disorder, etc) based on DSM-5®. However, this exclusion does not apply to the following: a) Caffeine- or tobacco-related disorders b) Disorders other than intellectual disability in the category of neurodevelopmental disorders
  • Patients who have met the DSM-5® diagnostic criteria for substance-related or addictive disorder, including alcohol and benzodiazepines but excluding caffeine and tobacco, within 180 days before commencement of IMP administration
  • Patients who have a clinically significant neurological, hepatic, renal, metabolic, hematological, immunological, cardiovascular, pulmonary, or gastrointestinal disorder. Medical conditions that are minor or well-controlled may be considered acceptable if the condition does not interfere with safety and efficacy assessments.
  • Patients with known hypersensitivity or intolerance to brexpiprazole or patients with confirmed resistance to brexpiprazole therapy
  • Patients judged by the investigator to be unsuitable for participation in the trial Rollover Subjects
  • Patients who have a clinically significant neurological, hepatic, renal, metabolic, hematological, immunological, cardiovascular, pulmonary, or gastrointestinal disorder. Medical conditions that are minor or well-controlled may be considered acceptable if the condition does not interfere with safety and efficacy assessments.
  • Patients judged by the investigator to be unsuitable for participation in the trial"

Sites / Locations

  • Hayakawa ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Rollover subjects

New subjects

Arm Description

For rollover subjects, treatment will begin with oral administration of 1 tablet of the brexpiprazole QW formulation at 24 mg. From Week 1 onward, 2 tablets of brexpiprazole QW formulation 24 mg (48 mg/week) will be orally administered for 51 weeks.

In medication switching period, treatment will begin with oral administration of 1 tablet of the brexpiprazole QW formulation 24 mg, and the dose of the other antipsychotics will be gradually reduced, finally switching to monotherapy with 2 tablets of brexpiprazole QW formulation 24 mg (48 mg/week) by Week 4. In treatment period, 2 tablets of brexpiprazole QW formulation 24 mg (48 mg/week) will be orally administered for 52 weeks.

Outcomes

Primary Outcome Measures

The frequency of Adverse Events

Secondary Outcome Measures

Full Information

First Posted
April 6, 2022
Last Updated
September 7, 2023
Sponsor
Otsuka Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05326347
Brief Title
A Long-term Administration Trial of Brexpiprazole Once-weekly (QW) Formulation in Patients With Schizophrenia
Official Title
A Multicenter, Uncontrolled, Open-label Trial to Investigate the Long-term Tolerability, Safety, and Efficacy of Brexpiprazole Once-weekly (QW) Formulation Administered Once Weekly for 52 Weeks in Patients With Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 31, 2022 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
February 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Otsuka Pharmaceutical Co., Ltd.

4. Oversight

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

5. Study Description

Brief Summary
Confirm the tolerability and safety of long-term administration of the brexpiprazole QW formulation in patients with schizophrenia

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
190 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Rollover subjects
Arm Type
Experimental
Arm Description
For rollover subjects, treatment will begin with oral administration of 1 tablet of the brexpiprazole QW formulation at 24 mg. From Week 1 onward, 2 tablets of brexpiprazole QW formulation 24 mg (48 mg/week) will be orally administered for 51 weeks.
Arm Title
New subjects
Arm Type
Experimental
Arm Description
In medication switching period, treatment will begin with oral administration of 1 tablet of the brexpiprazole QW formulation 24 mg, and the dose of the other antipsychotics will be gradually reduced, finally switching to monotherapy with 2 tablets of brexpiprazole QW formulation 24 mg (48 mg/week) by Week 4. In treatment period, 2 tablets of brexpiprazole QW formulation 24 mg (48 mg/week) will be orally administered for 52 weeks.
Intervention Type
Drug
Intervention Name(s)
OPC-34712FUM/ Brexpiprazole fumarate
Intervention Description
The treatment will begin with oral administration of 1 tablet of the brexpiprazole QW formulation.
Primary Outcome Measure Information:
Title
The frequency of Adverse Events
Time Frame
From baseline to week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: New Subjects Patients who have been fully informed of and understand the objectives, procedures, risks, and expected medicinal benefits of the trial and are able to provide written informed consent prior to initiation of any trial-related procedures Patients at least 18 years of age and below the age of 75 at the time of informed consent Patients with a diagnosis of schizophrenia based on DSM-5® at the time of informed consent Patients who are receiving treatment with antipsychotics (other than clozapine), who are considered to require maintenance therapy using antipsychotics, and for whom monotherapy with the brexpiprazole QW formulation and outpatient management are considered feasible. Hospitalization for washout from any previously used drugs specified as prohibited concomitant drugs or hospitalization for symptom management immediately after the start of IMP administration will be allowed at the discretion of the investigator. Hospitalization for social reasons (eg, homelessness or need for shelter that is unrelated to the patient's psychological condition) is permitted. Period 1: - Patients for whom switching to monotherapy with the brexpiprazole QW formulation using an add-on and taper-off method within 4 weeks is considered feasible Period 2: Patients who are able to begin monotherapy with the brexpiprazole QW formulation (at an initial dose of 48 mg/week) Rollover Subjects Patients who have been fully informed of and understand the objectives, procedures, risks, and expected medicinal benefits of the trial and are able to provide written informed consent prior to initiation of any trial-related procedures Patients who have completed the 6-week double-blind treatment period in Trial 331-102-00062 Patients for whom monotherapy with the brexpiprazole QW formulation and outpatient management are considered feasible. Hospitalization for symptom management immediately after the start of IMP administration will be allowed at the discretion of the investigator. Hospitalization for social reasons (eg, homelessness or need for shelter that is unrelated to the patient's psychological condition) is permitted. "Exclusion Criteria: New Subjects Patients who are considered resistant/refractory to antipsychotic treatment Patients who are Patients who are considered resistant/refractory to antipsychotic treatment Patients who are "unresponsive to medication with 2 or more antipsychotics at effective doses for a sufficiently long duration (6 weeks)" will be deemed resistant/refractory to antipsychotic treatment. Patients experiencing acute depressive symptoms within 30 days prior to informed consent that, in the judgment of the investigator, require treatment with an antidepressant Patients who fall under any of the following criteria regarding suicidal ideation and suicidal behavior Patients who answered "yes" to Question 4 "Active Suicidal Ideation with Some Intent to Act, without Specific Plan" or Question 5 "Active Suicidal Ideation with Specific Plan and Intent" regarding Columbia-Suicide Severity Rating Scale (C-SSRS) suicidal ideation at screening (for the past 6 months) or at baseline (since the last assessment) Patients who exhibited suicidal behavior on C-SSRS at screening (for the past 2 years) or at baseline (since the last assessment) Patients who present a serious risk of suicide based on the judgment of the investigator Patients presenting tardive dyskinesia at the time of informed consent, as determined by a score of 3 (moderate) or 4 (severe) for Item 8 (severity of abnormal movements) of the Abnormal Involuntary Movement Scale (AIMS) at screening or at baseline Patients with a score of 5 (severe akathisia) in the Barnes Akathisia Rating Scale (BARS) global clinical assessment of akathisia at screening or at baseline Patients with a diagnosis of a concurrent mental disorder besides schizophrenia (schizoaffective disorder, major depressive disorder, bipolar I disorder, bipolar II disorder, general anxiety disorder, obsessive-compulsive disorder, post-traumatic stress disorder, dementia or mild neurocognitive disorder, personality disorder, etc) based on DSM-5®. However, this exclusion does not apply to the following: • Caffeine- or tobacco-related disorder Patients who have met the DSM-5® diagnostic criteria for substance-related or addictive disorder, including alcohol and benzodiazepines but excluding caffeine and tobacco, within 180 days before commencement of IMP administration Patients who have a clinically significant neurological, hepatic, renal, metabolic, hematological, immunological, cardiovascular, pulmonary, or gastrointestinal disorder. Medical conditions that are minor or well-controlled may be c+E97onsidered acceptable if the condition does not interfere with safety and efficacy assessments. Patients with known hypersensitivity or intolerance to brexpiprazole or patients with confirmed resistance to brexpiprazole therapy Patients judged by the investigator to be unsuitable for participation in the trial Rollover Subjects Patients who have a clinically significant neurological, hepatic, renal, metabolic, hematological, immunological, cardiovascular, pulmonary, or gastrointestinal disorder. Medical conditions that are minor or well-controlled may be considered acceptable if the condition does not interfere with safety and efficacy assessments. Patients judged by the investigator to be unsuitable for participation in the trial
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Drug Information Center
Phone
+81-3-6361-7314
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Takehisa Matsumaru
Organizational Affiliation
Otsuka Pharmaceutical Co., Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Hayakawa Clinic
City
Kure-shi
Country
Japan
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal.
IPD Sharing Time Frame
Data will be available after marketing approval in global markets, or beginning 1-3 years following article Publication. There is no end date to the availability of the data.
IPD Sharing Access Criteria
Otsuka will share data on an Otsuka-owned remotely accessible data sharing platform with Python and R analytical software. Research requests should be directed to clinicaltransparency@Otsuka-us.com.

Learn more about this trial

A Long-term Administration Trial of Brexpiprazole Once-weekly (QW) Formulation in Patients With Schizophrenia

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