ADHDPhase 1NCT03292848
Trial to Assess the Pharmacokinetics, Safety, Tolerability of Oral Brexpiprazole in Children (6 to <13 Years Old) With Central Nervous System Disorders
A Phase 1 study testing Brexpiprazole in people with ADHD and Autism, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 9 sites in United States.
Trial summary
A study to assess pharmacokinetics, safety and tolerability of brexpiprazole in children ages 6 to <13 years with CNS disorders. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- ADHD, Autism, Bipolar I Disorder
- What is being tested?
- Brexpiprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 9 sitesUnited States
- Study dates
- 10 Oct 2017to 21 May 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male and female subjects between 6 and 12 years of age
- Subjects with CNS disorders including, but not limited to, ADHD, autism spectrum disorders, bipolar I disorder (subjects 10 to 12 years old only for bipolar), conduct disorder, oppositional defiant disorder, or any psychotic disorder and who are receiving antipsychotic treatment for their medical condition. Subjects' diagnoses will be determined by the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria and confirmed at screening using the Kiddie Schedule for Affective Disorders and Schizophrenia-Present and Lifetime version (K-SADS-PL).
- Subjects must be considered psychiatrically/medically appropriate for participation in a clinical trial in which they will receive two doses of an antipsychotic medication.
- Subjects with good physical health, as determined by no clinically significant deviation from normal for all of the following, prior to enrollment in the trial:
- Medical history
- Clinical laboratory determination
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- ECGs
- Physical examinations
- Subjects who are within the 5th to 95th percentile for gender-specific BMI for age from the Centers for Disease Control and Prevention growth charts and weight at least 15 kg (approx. 33 lbs)
- Ability to commit to remain fully abstinent or use 2 approved methods of birth control during the trial for 21 (± 2) days following the last dose of IMP for sexually active females of childbearing potential.
- Ability, in the opinion of the PI, of the subject and the subject's legally acceptable representative or caregiver(s) to understand the nature of the trial and follow protocol requirements, including all of the following:
- Comply with prescribed dosage regimens and tablet ingestion, as well as the discontinuation of prohibited concomitant medications
- Reliably return for scheduled visits
- To be reliably rated on assessment scales
Who cannot join
- 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) other than those listed in the second inclusion criterion above, or direct effect of a substance (ie, medication, illicit drug use, etc.).
- Subjects with a history of at least mild intellectual disability as determined by IQ < 70, clinical evidence, or a social or school history that is suggestive of intellectual disability.
- Subjects who have any of the following:
- A significant risk of committing suicide based on history and the principal investigator's clinical judgment, or routine psychiatric status examination
- Current suicidal behavior
- Imminent risk of injury; active suicidal ideation
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- Any lifetime history of suicidal behavior detected by the Children's Baseline/Screening version of the C-SSRS.
- Subjects with a lifetime history of a substance use disorder (as determined by the DSM-5 criteria), or current substance misuse including alcohol and benzodiazepines, but excluding caffeine and nicotine.
- Subjects who currently have clinically significant neurological, hepatic, renal, metabolic, hematological, immunological, cardiovascular, pulmonary, or gastrointestinal disorders such as any history of myocardial infarction, congestive heart failure, HIV seropositive status/acquired immunodeficiency syndrome, or chronic hepatitis B or C. Medical conditions that are minor or well-controlled may be considered acceptable if the condition does not expose the subject to an undue risk of significant adverse event or interfere with assessments during the course of the trial.
- Subjects with insulin dependent diabetes mellitus (IDDM) are excluded. Subjects with non-IDDM may be eligible for the trial if their condition is determined to be stable.
- Subjects with epilepsy or a history of seizures (except for a single seizure episode, for instance childhood febrile seizure or post traumatic) or a history of severe head trauma or cerebrovascular disease (eg, stroke, transient ischemic attack, etc.).
- Any major surgery within 30 days prior to the first dose of IMP.
- Any history of significant bleeding or hemorrhagic tendencies.
- Blood transfusions within 30 days prior to first dose of IMP.
- Subjects with a positive drug screen for cocaine, marijuana (even if by prescription), or other illicit drugs, or alcohol are excluded and may not be retested or rescreened.
- Subjects who have supine or standing diastolic blood pressure, after resting for at least 5 minutes, ≥ 95 mmHg.
- Subjects who have had a dose of depot antipsychotics within 6 months of screening.
- Consumption of alcohol or grapefruit, grapefruit juice, Seville oranges, or Seville orange juice within 72 hours prior to the first dose of IMP and throughout the trial
- Subjects who participated in a clinical trial and were exposed to IMP within the last 30 days prior to screening or who participated in more than 2 interventional clinical trials within the past year.
- Subjects with a history of neuroleptic malignant syndrome or hypersensitivity to atypical antipsychotics.
- Subjects with a history of true allergic (i.e. not intolerance) response to more than one class of medications.
- Subjects with a history of allergic reaction or a known or suspected sensitivity to any substance that is contained in the IMP formula.
- Subjects who do not tolerate venipuncture or have poor venous access that would cause difficulty for collecting blood samples.
- Prisoners or subjects who are compulsorily detained (e.g. juvenile detention, court-mandated treatment) for any reason.
- Inability to tolerate oral medication or swallow tablets.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
New Hope Clinical Research
Charlotte, North Carolina, 28211
Woodland International Research Group
Little Rock, Arkansas, 72211
Alliance for Wellness dba Alliance for Research
Long Beach, California, 90807
IPS Research Company
Oklahoma City, Oklahoma, 73103
Cutting Edge Research Group
Oklahoma City, Oklahoma, 73116
Aspen Clinical Research
Orem, Utah, 84058
Woodland Research Northwest, LLC
Rogers, Arkansas, 72758
Clinical Trials of Texas, Inc.
San Antonio, Texas, 78229
Road Runner Research Ltd.
San Antonio, Texas, 78249
About this study
Official title: A Phase 1, Single-dose, Sequential Cohort, Nonrandomized Crossover Trial to Assess the Pharmacokinetics, Safety, and Tolerability of Oral Brexpiprazole in Children (6 to< 13 Years Old) With Central Nervous System Disorders
A study to assess pharmacokinetics, safety and tolerability of brexpiprazole in children ages 6 to <13 years with CNS disorders.
Read the detailed description
A US based nonrandomized, sequential cohort, crossover trial to assess pharmacokinetics, safety and tolerability of brexpiprazole in children ages 6 to <13 years with CNS disorders who are receiving antipsychotic treatment for their medical condition.
- Being tested
- Brexpiprazole
- Keywords
- CNS Disorders, Brexpiprazole
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Autistic Disorder, Conduct Disorder, Oppositional Defiant Disorder, Central Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrexpiprazoleDrug
Also called OPC-34712
Tablet
| Study group | Role | What they receive |
|---|---|---|
| 10 to <13 Years of Age | Experimental | Two doses will be administered with a washout period of 14 days between the first dose of 1.5 mg the second dose of 3 mg. Receives: Drug: Brexpiprazole |
| 6 to <10 Years of Age | Experimental | Two doses will be administered with a washout period of 14 days between the first dose of 0.75 mg and the second dose of 1.5 mg. Receives: Drug: Brexpiprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Concentration (Cmax) [PK]
The maximum plasma concentration of drug will be assessed for brexpiprazole and its major metabolite DM-3411.
Measured: Up to 22 days or early termination
Area under concentration-time curve (AUC) calculated from time zero to time t (AUCt) [PK]
AUCt will be assessed for plasma brexpiprazole and its major metabolite DM-3411 to determine average concentration of drug over time
Measured: Up to 22 days or early termination
AUC from time zero to infinity [PK]
AUC infinity will be assessed for plasma brexpiprazole and its major metabolite DM-3411 to determine total drug exposure over time
Measured: Up to 22 days or early termination
Time of maximum plasma concentration (tmax) [PK]
The amount of time that the maximum plasma concentration of drug will be assessed for plasma brexpiprazole and its major metabolite DM-3411
Measured: Up to 22 days or early termination
Terminal-phase elimination half-life (t½,z) [PK]
t½,z will be assessed for plasma brexpiprazole and its major metabolite DM-3411 to determine drug persistence in the body
Measured: Up to 22 days or early termination
Apparent clearance of drug from plasma after extravascular administration (CL/F) [PK]
CL/F for brexpiprazole only
Measured: Up to 22 days or early termination
Secondary outcomes (15)
Treatment-Emergent Adverse Events (TEAES) [Safety]
Measured: Up to 22 days or early termination with a 21 day follow-up period
Clinical laboratory tests [Safety]
Collect hematology, serum chemistry,and urinalysis will be assessed to determine the safety and tolerability of drug
Measured: Up to 22 days or early termination
Vital signs observed and change from baseline data (systolic and diastolic blood pressure) [Safety]
Measured: Up to 22 days or early termination
Vital signs observed and change from baseline data (heart rate) [Safety]
Measured: Up to 22 days or early termination
Vital signs observed and change from baseline data (respiratory rate) [Safety]
Measured: Up to 22 days or early termination
Vital signs observed and change from baseline data (body temperature) [Safety]
Measured: Up to 22 days or early termination
12-lead electrocardiogram (ECGs) [Safety]
Measured: Up to 22 days or early termination
Physical examinations (height) [Safety]
Height is measured in cm,and will be used to calculate Body Mass Index (BMI)
Measured: Up to 22 days or early termination
Physical examinations (weight) [Safety]
Weight is measured in kg, and will be used to calculate Body Mass Index (BMI)
Measured: Up to 22 days or early termination
Physical examinations- Body Mass Index (BMI) [Safety]
Body Mass Index (BMI) measured using height (cm) and weight (kg)
Measured: Up to 22 days or early termination
Physical examinations- review of body systems [Safety]
Subject will be examined by site staff for any notable changes
Measured: Up to 22 days or early termination
Simpson-Angus Scale (SAS) rating scale [Safety]
Will be used in analysis of Extrapyramidal Symptoms (EPS)
Measured: Up to 22 days or early termination
Abnormal Involuntary Movement Scale (AIMS) [Safety]
Will be used in analysis of Extrapyramidal Symptoms (EPS)
Measured: Up to 22 days or early termination
Barnes Akathisia Rating Scale (BARS) [Safety]
Will be used in analysis of Extrapyramidal Symptoms (EPS)
Measured: Up to 22 days or early termination
Columbia-Suicide Severity Rating Scale (C-SSRS) [Safety]
Measured: Up to 22 days or early termination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2017
- Study start10 Oct 2017
- Primary completion21 May 2018
- Study completion21 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies of the same condition, open and under way.
- More trials run by Otsuka Pharmaceutical Development & Commercialization, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- H. Lundbeck A/S
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03292848
- Sponsor's protocol ID
- 331-201-00103
- Status last verified
- Jun 2018
- First submitted
- 21 Sep 2017
- Last updated
- 12 Jun 2018
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single-dose, Sequential Cohort, Nonrandomized Crossover Trial to Assess the Pharmacokinetics, Safety, and Tolerability of Oral Brexpiprazole in Children (6 to< 13 Years Old) With Central Nervous System Disorders
- ClinicalTrials.gov ID
- NCT03292848
- Acronym / sponsor ID
- 331-201-00103
- Keywords
- CNS Disorders, Brexpiprazole
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.Industry (pharma, biotech, devices)
- Collaborators
- H. Lundbeck A/S
- Study start
- 10 Oct 2017 (actual)
- Primary completion
- 21 May 2018 (actual)
- Study completion
- 21 May 2018 (actual)
- First posted
- 26 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study to assess pharmacokinetics, safety and tolerability of brexpiprazole in children ages 6 to <13 years with CNS disorders.
Detailed description
A US based nonrandomized, sequential cohort, crossover trial to assess pharmacokinetics, safety and tolerability of brexpiprazole in children ages 6 to <13 years with CNS disorders who are receiving antipsychotic treatment for their medical condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 10 to <13 Years of Age | Experimental | Drug: BrexpiprazoleTwo doses will be administered with a washout period of 14 days between the first dose of 1.5 mg the second dose of 3 mg. |
| 6 to <10 Years of Age | Experimental | Drug: BrexpiprazoleTwo doses will be administered with a washout period of 14 days between the first dose of 0.75 mg and the second dose of 1.5 mg. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (14 listed)
- Male and female subjects between 6 and 12 years of age
- Subjects with CNS disorders including, but not limited to, ADHD, autism spectrum disorders, bipolar I disorder (subjects 10 to 12 years old only for bipolar), conduct disorder, oppositional defiant disorder, or any psychotic disorder and who are receiving antipsychotic treatment for their medical condition. Subjects' diagnoses will be determined by the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria and confirmed at screening using the Kiddie Schedule for Affective Disorders and Schizophrenia-Present and Lifetime version (K-SADS-PL).
- Subjects must be considered psychiatrically/medically appropriate for participation in a clinical trial in which they will receive two doses of an antipsychotic medication.
- Subjects with good physical health, as determined by no clinically significant deviation from normal for all of the following, prior to enrollment in the trial:
- Subjects who are within the 5th to 95th percentile for gender-specific BMI for age from the Centers for Disease Control and Prevention growth charts and weight at least 15 kg (approx. 33 lbs)
Key exclusion criteria (25 listed)
- 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) other than those listed in the second inclusion criterion above, or direct effect of a substance (ie, medication, illicit drug use, etc.).
- Subjects with a history of at least mild intellectual disability as determined by IQ < 70, clinical evidence, or a social or school history that is suggestive of intellectual disability.
- Subjects who have any of the following:
- Subjects with a lifetime history of a substance use disorder (as determined by the DSM-5 criteria), or current substance misuse including alcohol and benzodiazepines, but excluding caffeine and nicotine.
- Subjects who currently have clinically significant neurological, hepatic, renal, metabolic, hematological, immunological, cardiovascular, pulmonary, or gastrointestinal disorders such as any history of myocardial infarction, congestive heart failure, HIV seropositive status/acquired immunodeficiency syndrome, or chronic hepatitis B or C. Medical conditions that are minor or well-controlled may be considered acceptable if the condition does not expose the subject to an undue risk of significant adverse event or interfere with assessments during the course of the trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BrexpiprazoleAlso: OPC-34712Tablet | Drug | 10 to <13 Years of Age, 6 to <10 Years of Age |
Primary outcome
Maximum Plasma Concentration (Cmax) [PK]
Time frame: Up to 22 days or early termination
The maximum plasma concentration of drug will be assessed for brexpiprazole and its major metabolite DM-3411.
Area under concentration-time curve (AUC) calculated from time zero to time t (AUCt) [PK]
Time frame: Up to 22 days or early termination
AUCt will be assessed for plasma brexpiprazole and its major metabolite DM-3411 to determine average concentration of drug over time
AUC from time zero to infinity [PK]
Time frame: Up to 22 days or early termination
AUC infinity will be assessed for plasma brexpiprazole and its major metabolite DM-3411 to determine total drug exposure over time
Time of maximum plasma concentration (tmax) [PK]
Time frame: Up to 22 days or early termination
The amount of time that the maximum plasma concentration of drug will be assessed for plasma brexpiprazole and its major metabolite DM-3411
Terminal-phase elimination half-life (t½,z) [PK]
Time frame: Up to 22 days or early termination
t½,z will be assessed for plasma brexpiprazole and its major metabolite DM-3411 to determine drug persistence in the body
Apparent clearance of drug from plasma after extravascular administration (CL/F) [PK]
Time frame: Up to 22 days or early termination
CL/F for brexpiprazole only
15 secondary outcomes
Treatment-Emergent Adverse Events (TEAES) [Safety]
Time frame: Up to 22 days or early termination with a 21 day follow-up period
Clinical laboratory tests [Safety]
Time frame: Up to 22 days or early termination
Vital signs observed and change from baseline data (systolic and diastolic blood pressure) [Safety]
Time frame: Up to 22 days or early termination
Vital signs observed and change from baseline data (heart rate) [Safety]
Time frame: Up to 22 days or early termination
Vital signs observed and change from baseline data (respiratory rate) [Safety]
Time frame: Up to 22 days or early termination
Vital signs observed and change from baseline data (body temperature) [Safety]
Time frame: Up to 22 days or early termination
12-lead electrocardiogram (ECGs) [Safety]
Time frame: Up to 22 days or early termination
Physical examinations (height) [Safety]
Time frame: Up to 22 days or early termination
Physical examinations (weight) [Safety]
Time frame: Up to 22 days or early termination
Physical examinations- Body Mass Index (BMI) [Safety]
Time frame: Up to 22 days or early termination
Physical examinations- review of body systems [Safety]
Time frame: Up to 22 days or early termination
Simpson-Angus Scale (SAS) rating scale [Safety]
Time frame: Up to 22 days or early termination
Abnormal Involuntary Movement Scale (AIMS) [Safety]
Time frame: Up to 22 days or early termination
Barnes Akathisia Rating Scale (BARS) [Safety]
Time frame: Up to 22 days or early termination
Columbia-Suicide Severity Rating Scale (C-SSRS) [Safety]
Time frame: Up to 22 days or early termination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Brexpiprazole in people with ADHD and Autism, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Plasma Concentration (Cmax) [PK] (time frame: Up to 22 days or early termination). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2018.