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

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03238326
• Other study ID #: 331-10-236
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: August 23, 2017
• Est. completion date: May 2025

Study information

• Verified date: June 2024
• Source: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To further characterize the long-term safety and tolerability of brexpiprazole in adolescents with schizophrenia

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 296
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Brexpiprazole
Once daily, oral tablets

Locations

Country	Name	City	State
United States	For additional information regarding sites, contact 844-687-8522	Kinston	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Development & Commercialization, Inc.	H. Lundbeck A/S

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency & Severity of Adverse Events (AE) [Safety]	Frequency and severity will be monitored; along with serious AEs & discontinuation from trial due to AE	Up to 24 months or early termination with a 21 day follow-up period
Secondary	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	Up to 24 months or early termination
Secondary	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	Up to 24 months or early termination with a 21 day follow-up period
Secondary	Weight [Safety]	Change in weight, in kilograms, will be assessed for any notable differences from baseline	Up to 24 months or early termination
Secondary	Height [Safety]	Change in height, in centimeters, will be assessed for any notable differences from baseline	Up to 24 months or early termination
Secondary	Body Mass Index (BMI) [Safety]	Measured in kilograms/meter^2 and assessed to determine any notable differences from baseline	Up to 24 months or early termination
Secondary	Waist Circumference [Safety]	Change in waist circumference, in centimeters will be assessed for any notable differences from baseline	Up to 24 months or early termination
Secondary	Changes in ECG [Safety]	Mean change from baseline will be assessed and incidence of clinically significant abnormalities	Up to 24 months or early termination
Secondary	Change in Abnormal Involuntary Movement Scale (AIMS) Score [Safety]	Mean change from baseline will be assessed	Up to 24 months or early termination
Secondary	Change in Simpson-Angus Scale (SAS) Score [Safety]	Mean change from baseline will be assessed	Up to 24 months or early termination
Secondary	Change in Barnes Akathisia Rating Scale (BARS) Score [Safety]	Mean change from baseline will be assessed	Up to 24 months or early termination
Secondary	Potential suicide events recorded on the Columbia-Suicide Severity Rating Scale (C-SSRS) [Safety]	Analysis of potential suicide events recorded with C SSRS	Up to 24 months or early termination
Secondary	Comprehensive psychotropic side effects as assessed by Udvalg for Kliniske Undersogelser (UKU) [Safety]	Psychotropic side effects will be assessed by UKU	Up to 24 months or early termination
Secondary	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	Up to 24 months or early termination
Secondary	Change in Tanner Staging Scale Scores [Safety]	Baseline and post-baseline data will be assessed	Up to 24 months or early termination
Secondary	Time to discontinuation due to AE	Time to discontinue will be assessed as applicable	Up to 24 months or early termination
Secondary	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.	Up to 24 months or early termination
Secondary	Change in Children's Global Assessment Scale (CGAS) Score	Change from baseline in CGAS will be assessed for efficacy of drug	Up to 24 months or early termination
Secondary	Change in Clinical Global Impression Severity (CGI-S) Score		Up to 24 months or early termination
Secondary	Change in Clinical Global Impression Improvement (CGI-I) Score		Up to 24 months or early termination