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

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ClinicalTrials.gov Identifier: NCT03238326
Recruitment Status : Recruiting
First Posted : August 3, 2017
Last Update Posted : August 1, 2019
Sponsor:
Collaborator:
H. Lundbeck A/S
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.

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

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Brexpiprazole Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Actual Study Start Date : August 23, 2017
Estimated Primary Completion Date : November 2023
Estimated Study Completion Date : November 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: Rollover & De-Novo
1-4 mg/day; Start at 0.5 mg/day, titrate and maintain between 1mg/day to max of 4 mg/day
Drug: Brexpiprazole
Once daily, oral tablets
Other Name: OPC-34712




Primary Outcome Measures :
  1. Frequency & Severity of Adverse Events (AE) [Safety] [ Time Frame: Up to 24 months or early termination with a 21 day follow-up period ]
    Frequency and severity will be monitored; along with serious AEs & discontinuation from trial due to AE


Secondary Outcome Measures :
  1. Mean change from baseline and incidence of clinically significant abnormalities in clinical laboratory tests [Safety] [ Time Frame: Up to 24 months or early termination ]
    Abnormalities in hematology, serum chemistry [including fasting blood lipids, glucose and insulin, serum prolactin], glycosylated hemoglobin [HbA1c], creatine phosphokinase [CPK] and urinalysis) results

  2. Mean change from baseline and incidence of clinically significant abnormalities in vital signs [Safety] [ Time Frame: Up to 24 months or early termination with a 21 day follow-up period ]
    Mean change from baseline in supine and standing positions will be assessed and incidence of clinically significant abnormalities

  3. Weight [Safety] [ Time Frame: Up to 24 months or early termination ]
    Change in weight, in kilograms, will be assessed for any notable differences from baseline

  4. Height [Safety] [ Time Frame: Up to 24 months or early termination ]
    Change in height, in centimeters, will be assessed for any notable differences from baseline

  5. Body Mass Index (BMI) [Safety] [ Time Frame: Up to 24 months or early termination ]
    Measured in kilograms/meter^2 and assessed to determine any notable differences from baseline

  6. Waist Circumference [Safety] [ Time Frame: Up to 24 months or early termination ]
    Change in waist circumference, in centimeters will be assessed for any notable differences from baseline

  7. Changes in ECG [Safety] [ Time Frame: Up to 24 months or early termination ]
    Mean change from baseline will be assessed and incidence of clinically significant abnormalities

  8. Change in Abnormal Involuntary Movement Scale (AIMS) Score [Safety] [ Time Frame: Up to 24 months or early termination ]
    Mean change from baseline will be assessed

  9. Change in Simpson-Angus Scale (SAS) Score [Safety] [ Time Frame: Up to 24 months or early termination ]
    Mean change from baseline will be assessed

  10. Change in Barnes Akathisia Rating Scale (BARS) Score [Safety] [ Time Frame: Up to 24 months or early termination ]
    Mean change from baseline will be assessed

  11. Potential suicide events recorded on the Columbia-Suicide Severity Rating Scale (C-SSRS) [Safety] [ Time Frame: Up to 24 months or early termination ]
    Analysis of potential suicide events recorded with C SSRS

  12. Comprehensive psychotropic side effects as assessed by Udvalg for Kliniske Undersogelser (UKU) [Safety] [ Time Frame: Up to 24 months or early termination ]
    Psychotropic side effects will be assessed by UKU

  13. The frequency of symptom items from New York Assessment for Adverse Cognitive Effects of Neuropsychiatric Treatment (NY-AACENT) [Safety] [ Time Frame: Up to 24 months or early termination ]
    Frequency of symptom items will be assessed

  14. Change in Tanner Staging Scale Scores [Safety] [ Time Frame: Up to 24 months or early termination ]
    Baseline and post-baseline data will be assessed

  15. Time to discontinuation due to AE [ Time Frame: Up to 24 months or early termination ]
    Time to discontinue will be assessed as applicable

  16. Change in the Positive and Negative Syndrome Scale (PANSS) Total Score and PANSS Subscale Scores [ Time Frame: Up to 24 months or early termination ]
    Change from baseline in total score will be assessed for efficacy of drug. Positive/Negative subscale scores will be assessed for efficacy of drug.

  17. Change in Children's Global Assessment Scale (CGAS) Score [ Time Frame: Up to 24 months or early termination ]
    Change from baseline in CGAS will be assessed for efficacy of drug

  18. Change in Clinical Global Impression Severity (CGI-S) Score [ Time Frame: Up to 24 months or early termination ]
  19. Change in Clinical Global Impression Improvement (CGI-I) Score [ Time Frame: Up to 24 months or early termination ]


Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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, the current diagnosis of schizophrenia must be 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

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): NCT03238326


Locations
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United States, California
Alliance for Wellness dba Alliance for Research Recruiting
Long Beach, California, United States, 90807
Contact: Andrea Hillard    562-548-8500    ahilliard@allianceforresearch.com   
United States, New York
Manhattan Behavioral Medicine, PLLC Recruiting
New York, New York, United States, 10036
Contact: Judith Joseph    646-678-4196    recruitment@nymbm.com   
Finger Lakes Clinical Research Recruiting
Rochester, New York, United States, 14618
Contact: Tracie Doerner    585-241-9670    flcr@flclinical.com   
United States, Washington
Eastside Therapeutic Resource dba Core Clinical Research Recruiting
Everett, Washington, United States, 98201
Contact: Maria Golescu    425-443-9551    maria.golescu@ccrtrial.com   
Serbia
Clinic of Neurology and Psychiatry for Children and Youth Recruiting
Belgrade, Serbia, 11000
Contact: Vesna Milovanovic    381 65 3135 060    Vesna.milovanovic@hotmail.rs   
Institute of Mental Health Recruiting
Belgrade, Serbia, 11000
Contact: Milica Pejovic-Milovancevic    381 63 343 969    milica.pejovic@imh.org.rs   
Clinical Centre Kragujevac, Clinic of Psychiatry Recruiting
Kragujevac, Serbia, 34000
Contact: Vladimir Janic    381 64 1133 706    vladadok@yahoo.com   
Clinical Center Vojvodina, Clinic of psychiatry, Department for child and adolescent psychiatry Recruiting
Novi Sad, Serbia, 21000
Contact: Svetlana Ivanovic-Kovacevic    381 60 3655 440    svetlanaivankov@gmail.com   
Ukraine
Communal Institution "Dnipropetrovsk Children's Municipal Hospital named #5" Dnepropetrovsk Regional Council" Recruiting
Dnipro, Ukraine, 49027
Contact: Svitlana Moroz    380 67 565 8914    psookbm@gmail.com   
SI Institute of Neurology, Psychiatry and Narcology of NAMSU, Department of Clinical, Social and Child Psychiatry Recruiting
Kharkiv, Ukraine, 61068
Contact: Valerii Pidkorytov    380 50 683 4133    pid-vs@ukr.net   
State Institution "Institute of the Health Care of Children and Adolescents of the National Academy of Medical Sciences of Ukraine", Psychiatry Department Recruiting
Kharkiv, Ukraine
Contact: Tetiana Matkovska    380 502 39 6366    2396366@gmail.com   
Kherson Regional Psyciatric Hospital Recruiting
Kherson, Ukraine, 73488
Contact: Pavlo Palamarchuk    380 50 494 0457    pavel.palamarchuk@mental.kherson.ua   
Communal Institution of Lviv Regional Council "Lviv Regional Clinical Psychiatric Hospital" Recruiting
Lviv, Ukraine, 79021
Contact: Oleksandr Filts    380 67 670 28 27    filz.uuap@gmail.com   
CE'' Poltava Regional Clinical Psychiatric Hospital named after O. F. Maltsev Recruiting
Poltava, Ukraine, 36013
Contact: Andrii Skrypnikov    380 50 252 3300    skripnikovan@mail.ru   
Ternopil Regional Municipal Clinical Psychoneurological Hospital Recruiting
Ternopil, Ukraine, 46027
Contact: Olena Venger    380 67 756 55 56    olenavenger@gmail.com   
Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
H. Lundbeck A/S
Investigators
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Study Director: Eva Kohegyi, M.D. Otsuka Pharmaceutical Development & Commercialization, Inc.

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Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT03238326     History of Changes
Other Study ID Numbers: 331-10-236
First Posted: August 3, 2017    Key Record Dates
Last Update Posted: August 1, 2019
Last Verified: July 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.:
Brexpiprazole
Schizophrenia
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Brexpiprazole
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Dopamine Agonists
Dopamine Agents