Study to Assess the Safety, Tolerability and Pharmacokinetics of Oral Brexpiprazole (OPC- 34712) … (NCT02411695) | Clinical Trial Compass
CompletedPhase 1
Study to Assess the Safety, Tolerability and Pharmacokinetics of Oral Brexpiprazole (OPC- 34712) in Adolescents With Schizophrenia
United States43 participantsStarted 2015-03
Plain-language summary
The purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of oral brexpipirazole in adolescent subjects with schizophrenia or Other Related Psychiatric Disorders.
Who can participate
Age range
13 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male and female subjects 13 to 17 years of age, inclusive, at the time of informed consent.
* Subjects with a current diagnosis of primary schizophrenia spectrum or bipolar spectrum disorder, as defined by DSM-IV-TR criteria, and confirmed by K-SADS-PL.
* No psychiatric hospitalizations within the past 12 weeks.
* Subjects require treatment with antipsychotic medications.
* Subjects who have received previous outpatient antipsychotic treatment at an adequate dose for an adequate duration (at least 6 weeks) and who showed a previous good response to such antipsychotic treatment (other than clozapine) in the last 12 months.
* Subjects with a body weight at Screening greater than or equal to 30 kg.
Exclusion Criteria:
* Sexually active females of childbearing potential and male subjects who are not practicing two different methods of birth control with their partner (or abstinence) during the trial and for 30 days after the last dose of trial medication
* Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving trial drug.
* Subjects who have received continuous medication therapy to treat schizophrenia and schizophrenia spectrum diagnosis for less than six months prior to first dose of study medication AND subjects who have received continuous medication therapy to treat bipolar and bipolar spectrum disorder for less than two months in the past three years; or subjects who require more than one antipsychotic..
*…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this was a Phase 1 trial in adolescents specifically studying safety, tolerability, and how the body processes brexpiprazole rather than whether it works — what does that mean for what we actually know about its effectiveness and long-term safety for a teenager with schizophrenia?
2The trial tracked things like heart rhythm changes on ECG, blood chemistry, and vital signs over just 17 days — are there any signals from those short-term measurements that you think are relevant to consider if brexpiprazole is being discussed as a treatment option for my child?
3This study is now completed — is the data from this adolescent pharmacokinetics trial being used to support any larger Phase 2 or Phase 3 trials, and would those later-stage studies be worth looking into as next steps?
4Given that this trial was measuring how brexpiprazole is absorbed and eliminated in adolescent bodies specifically, does that pharmacokinetic data change how a doctor would dose it differently for a teenager compared to an adult?
5Before considering brexpiprazole or any trial related to it, are there currently approved medications or standard-of-care treatments for adolescent schizophrenia that you would recommend trying first, and how would those compare?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Reported Adverse Events (AEs) at 30 day Follow-Up
Timeframe: 30 day Follow-Up
2
Change from Baseline to Day 17 in Vital Signs
Timeframe: Baseline to Day 17
3
Change from Baseline to Day 17 ECGs
Timeframe: Baseline to Day 17
4
Change from Baseline to Day 17 Hematology
Timeframe: Baseline to Day 17
5
Change from Baseline to Day 14 Physical examination
Timeframe: Baseline to Day 14
6
Change from Baseline to Day 17 Body weight
Timeframe: Baseline to Day 17
7
Change from Baseline to Day 17 Serum chemistry
Timeframe: Baseline to Day 17
8
Trial details
NCT IDNCT02411695
SponsorOtsuka Pharmaceutical Development & Commercialization, Inc.