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Trial record 50 of 68 for:    brexpiprazole

Study to Assess the Safety, Tolerability and Pharmacokinetics of Oral Brexpiprazole (OPC- 34712) in Adolescents With Schizophrenia

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ClinicalTrials.gov Identifier: NCT02411695
Recruitment Status : Completed
First Posted : April 8, 2015
Last Update Posted : February 15, 2017
Sponsor:
Collaborator:
H. Lundbeck A/S
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Brexpiprazole (OPC-34712) Phase 1

Detailed Description:
Schizophrenia is a severely delibitating mental illness that affects approximately 1% of the world population. The onset of schizophrenia symptoms typically peaks in late adolescence and early adulthood. In a minority of cases, the initial episode may occur during childhood or early adolescence. Patients who experience this "early-onset schizophrenia" exhibit symptoms that are more severe and follow a more chronic course; adolescents with schizophrenia may never achieve full remission of the initial episode. The prognosis for early-onset schizophrenia tends to be poor, and cognitive impairment is greater compared with individuals whose onset of schizophrenia occurs later in life. Several antipsychotics have been investigated for the treatment of adolescent schizophrenia, however, there is a particular challenge because developing bodies are more sensitive to side effects of antipsychotics, particularly with respect to weight gain. In order to enroll a population that includes the younger ages, adolescents with other related psychiatric disorders are also included in this study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Multicenter, Open-label, Dose-Escalation Trial to Assess the Safety, Tolerability and Pharmacokinetics of Oral Brexpiprazole (OPC- 34712) in Adolescents With Schizophrenia
Study Start Date : March 2015
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: Cohort 1
0.5 mg, Brexpipraxzole (OPC-34712)
Drug: Brexpiprazole (OPC-34712)
Subjects who are deemed eligible for the trial will be assigned to a dosing cohort and will enter a Dose Titration Phase during which they will receive a starting dose of brexpiprazole for 2 to 10 days based on their assigned titration schedule. The Dose Titration Phase may be extended up to a maximum of 14 days, based on the observed safety and tolerability profile of the previous cohort's Dose Titration Phase. Following the Dose Titration Phase, subjects will enter the Fixed Dose Phase and will be administered the assigned dose for that cohort for 14 days.

Experimental: Cohort 2
1mg, Brexpipraxzole (OPC-34712)
Drug: Brexpiprazole (OPC-34712)
Subjects who are deemed eligible for the trial will be assigned to a dosing cohort and will enter a Dose Titration Phase during which they will receive a starting dose of brexpiprazole for 2 to 10 days based on their assigned titration schedule. The Dose Titration Phase may be extended up to a maximum of 14 days, based on the observed safety and tolerability profile of the previous cohort's Dose Titration Phase. Following the Dose Titration Phase, subjects will enter the Fixed Dose Phase and will be administered the assigned dose for that cohort for 14 days.

Experimental: Cohort 3
2mg, Brexpipraxzole (OPC-34712)
Drug: Brexpiprazole (OPC-34712)
Subjects who are deemed eligible for the trial will be assigned to a dosing cohort and will enter a Dose Titration Phase during which they will receive a starting dose of brexpiprazole for 2 to 10 days based on their assigned titration schedule. The Dose Titration Phase may be extended up to a maximum of 14 days, based on the observed safety and tolerability profile of the previous cohort's Dose Titration Phase. Following the Dose Titration Phase, subjects will enter the Fixed Dose Phase and will be administered the assigned dose for that cohort for 14 days.

Experimental: Cohort 4
3 mg, Brexpipraxzole (OPC-34712)
Drug: Brexpiprazole (OPC-34712)
Subjects who are deemed eligible for the trial will be assigned to a dosing cohort and will enter a Dose Titration Phase during which they will receive a starting dose of brexpiprazole for 2 to 10 days based on their assigned titration schedule. The Dose Titration Phase may be extended up to a maximum of 14 days, based on the observed safety and tolerability profile of the previous cohort's Dose Titration Phase. Following the Dose Titration Phase, subjects will enter the Fixed Dose Phase and will be administered the assigned dose for that cohort for 14 days.

Experimental: Cohort 5
4mg, Brexpipraxzole (OPC-34712)
Drug: Brexpiprazole (OPC-34712)
Subjects who are deemed eligible for the trial will be assigned to a dosing cohort and will enter a Dose Titration Phase during which they will receive a starting dose of brexpiprazole for 2 to 10 days based on their assigned titration schedule. The Dose Titration Phase may be extended up to a maximum of 14 days, based on the observed safety and tolerability profile of the previous cohort's Dose Titration Phase. Following the Dose Titration Phase, subjects will enter the Fixed Dose Phase and will be administered the assigned dose for that cohort for 14 days.




Primary Outcome Measures :
  1. Reported Adverse Events (AEs) at 30 day Follow-Up [ Time Frame: 30 day Follow-Up ]
  2. Change from Baseline to Day 17 in Vital Signs [ Time Frame: Baseline to Day 17 ]
  3. Change from Baseline to Day 17 ECGs [ Time Frame: Baseline to Day 17 ]
  4. Change from Baseline to Day 17 Hematology [ Time Frame: Baseline to Day 17 ]
  5. Change from Baseline to Day 14 Physical examination [ Time Frame: Baseline to Day 14 ]
  6. Change from Baseline to Day 17 Body weight [ Time Frame: Baseline to Day 17 ]
  7. Change from Baseline to Day 17 Serum chemistry [ Time Frame: Baseline to Day 17 ]
    Including Prolactin concentrations

  8. Change from Baseline to Day 17 Urinalysis [ Time Frame: Baseline to Day 17 ]
  9. Maximal peak steady-state plasma concentration [ Time Frame: At Day 14 ]
  10. Minimum trough steady-state plasma concentration [ Time Frame: At Day 14 ]
  11. Time to maximum peak steady-state plasma concentration [ Time Frame: At Day 14 ]
  12. Area under the concentration-time curve during the dosing interval at steady-state [ Time Frame: At Day 14 ]
  13. Terminal elimination half-life [ Time Frame: At Day 14 ]
  14. For Brex only, apparent cleanse and apparent volume of distribution [ Time Frame: At Day 14 ]

Secondary Outcome Measures :
  1. Mean change in CGI-S score [ Time Frame: Day -1 of Dose Titration Phase to Day 7 and Day 14 of Fixed Dose Phase ]
  2. Mean change in CGI-I score [ Time Frame: Day 7 and Day 14 ]
  3. Glycosylated haemoglobin [HbA1c] [ Time Frame: Baseline to Day 17 ]
  4. Change from Baseline to Day 17 Adrenocorticotropic hormone [ACTH] [ Time Frame: Baseline to Day 17 ]
  5. Change from Baseline to Day 17 Cortisol [ Time Frame: Baseline to Day 17 ]
  6. Change from Baseline to Day 17 Thyroid stimulating hormone [TSH] [ Time Frame: Baseline to Day 17 ]
  7. Change from Baseline to Day 17 Prothrombin time [PT] [ Time Frame: Baseline to Day 17 ]
  8. Change from Baseline to Day 17 Activated partial thromboplastin time [aPTT] [ Time Frame: Baseline to Day 17 ]
  9. Change from Baseline to Day 17 International normalized ratio [INR] [ Time Frame: Baseline to Day 17 ]
  10. For subjects with a current primary schizophrenia spectrum diagnosis, mean change in Positive and Negative Syndrom Scale (PANSS) [ Time Frame: Day-1 to Day 15 ]
  11. For subjects with a current diagnosis of bipolar spectrum disorder, mean change in Young Mania Rating Scale (YMRS) [ Time Frame: Day -1 to Day 15 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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 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..
  • Subjects with a current DSM-IV-TR diagnosis other than schizophrenia spectrum , bipolar spectrum, including any Axis I or Axis II (DSM-IV-TR) disorder.
  • Subjects with a clinical presentation and/or history of any neurodevelopmental disorder
  • Subjects who have met DSM-IV-TR criteria for substance abuse or dependence within the past 180 days.
  • 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.
  • Subjects with IDDM (ie, any subjects using insulin) are excluded. Subjects with non-IDDM may be eligible for the trial if their condition is stable.
  • Subjects with epilepsy or a history of seizures.
  • Any major surgery or blood transfusion within 30 days prior to first dose of trial medication.
  • Subjects with a positive drug screen for cocaine or other illicit drugs, or alcohol are excluded and may not be retested or re-screened.
  • Prohibited concomitant medications used within the exclusionary period prior to Day 1 of the Dose Escalation Phase or anticipated need for such medications during the trial.
  • Subjects who participated in a clinical trial and were exposed to IMP within the last 30 days or who participated in more than two interventional clinical trials within the past year.
  • Subjects with a history of true allergic response (ie, not intolerance) to more than one class of medications.
  • Inability to tolerate oral medication or swallow tablets.

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): NCT02411695


Locations
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United States, Arkansas
Little Rock, Arkansas, United States, 72211
United States, California
Culver City, California, United States, 90230
Orange, California, United States, 92858
United States, District of Columbia
Washington, District of Columbia, United States, 20016
United States, Georgia
Atlanta, Georgia, United States, 30331
United States, New Jersey
Marlton, New Jersey, United States, 08053
United States, Ohio
Cincinnati, Ohio, United States, 45219
Cleveland, Ohio, United States, 44106
United States, Texas
The Woodlands, Texas, United States, 77381
United States, Utah
Orem, Utah, United States, 84058
Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
H. Lundbeck A/S
Investigators
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Study Director: Eva Kohegyi, MD Otsuka Pharmaceutical Development & Commercialization

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Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT02411695     History of Changes
Other Study ID Numbers: 331-10-233
First Posted: April 8, 2015    Key Record Dates
Last Update Posted: February 15, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:
Adolescent
Otsuka,
Brexpiprazole
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