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    Summary
    EudraCT Number:2010-018911-13
    Sponsor's Protocol Code Number:31-09-267
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2010-09-07
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2010-018911-13
    A.3Full title of the trial
    A Long-term, Multicenter, Open-Label Study to Evaluate the Safety and Tolerability of Flexible-Dose Oral Aripiprazole (OPC-14597) as Maintenance Treatment
    in Adolescent Patients with Schizophrenia or Child and Adolescent Patients with Bipolar I Disorder, Manic or Mixed Episode with or without Psychotic Features
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An open label study assessing safety and tolerability of aripirazole in Adolescent Patients with Schizophrenia or Child and Adolescent Patients with Bipolar I Disorder.
    A.3.2Name or abbreviated title of the trial where available
    ATTAIN
    A.4.1Sponsor's protocol code number31-09-267
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/99/2011
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorOtsuka Pharmaceutical Development & Commercialization, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportOtsuka Pharmaceutical Development & Commercialization, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMatthew Media Group (MMG)
    B.5.2Functional name of contact pointNot applicable
    B.5.3 Address:
    B.5.3.1Street AddressNot applicable
    B.5.3.2Town/ cityNot applicable
    B.5.3.3Post codeNot applicable
    B.5.3.4CountryUnited States
    B.5.6E-mailATTAINstudyinfo@mmgct.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Abilify
    D.2.1.1.2Name of the Marketing Authorisation holderOtsuka America Pharmaceutical, Inc.
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namearipiprazole 2 mg tablet
    D.3.2Product code OPC-14597
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAripiprazole
    D.3.9.1CAS number 129722-12-9
    D.3.9.2Current sponsor codeOPC-14597
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Abilify 5 mg tablet
    D.2.1.1.2Name of the Marketing Authorisation holderOtsuka Pharmaceutical Europe Ltd, Uxbridge, UK
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namearipiprazole 5 mg tablet
    D.3.2Product code OPC-14597
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAripiprazole
    D.3.9.1CAS number 129722-12-9
    D.3.9.2Current sponsor codeOPC-14597
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Abilify 10 mg tablet
    D.2.1.1.2Name of the Marketing Authorisation holderOtsuka Pharmaceutical Europe Ltd., Uxbridge, UK
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namearipiprazole 10 mg tablet
    D.3.2Product code OPC-14597
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAripiprazole
    D.3.9.1CAS number 129722-12-9
    D.3.9.2Current sponsor codeOPC-14597
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 4
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Abilify 15 mg tablet
    D.2.1.1.2Name of the Marketing Authorisation holderOtsuka Pharmaceutical Europe Ltd., Uxbridge, UK
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namearipiprazole 15 mg tablet
    D.3.2Product code OPC-14597
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAripiprazole
    D.3.9.1CAS number 129722-12-9
    D.3.9.2Current sponsor codeOPC-14597
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Schizophrenia in Adolescent Patients or Child and Adolescent Patients with Bipolar I Disorder, Manic or Mixed Episode with or without Psychotic Features
    E.1.1.1Medical condition in easily understood language
    Schizophrenia in Adolescents and Bipolar I disorder in Children and Adolescents.
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Behavioral Disciplines and Activities [F04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10039626
    E.1.2Term Schizophrenia
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10004939
    E.1.2Term Bipolar I disorder
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objective of this study is to further characterize the long-term safety and tolerability of aripiprazole in adolescent subjects with schizophrenia and child and adolescent subjects with Bipolar I Disorder, manic or mixed episode, with or without psychotic features.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion Criteria Assessed at Screening
    1. Study specific written informed consent/assent obtained from a parent/guardian or legally acceptable representative,
    as applicable for local laws, prior to the initiation of any
    protocol-required procedures. In addition, the subject must provide informed assent at screening and must be able to
    understand that he or she can withdraw from the study at any time. All informed consent/assent procedures must be in accordance with the study center’s institutional review
    board/ethics committee (IRB/IEC) and local regulatory requirements. If the rollover subject should turn 18 years of age (or the age of adulthood as specified by local laws or regulations) within 4 weeks prior to entry into Study 267 or during Study 267 participation, an informed consent must be obtained from the subject.

    2) Adolescent male and female subjects including:
    Schizophrenia:
    • De novo subjects aged 13 to 17 years at the time of signing the informed consent/assent
    • Rollover subjects from Study 266
    Bipolar Manic or Mixed Episode:
    • De novo subjects aged 10 to 17 years at the time of signing the informed consent/assent.

    3. All Subjects: Co-morbid diagnoses are permitted including Attention Deficit Disorder (ADD), Attention Deficit Hyperactivity Disorder (ADHD), Conduct Disorder (CD), and Oppositional Defiant Disorder (ODD) and anxiety disorders (except Post Traumatic Stress Disorder [PTSD] and Obsessive Compulsive Disorder [OCD]).
    Subjects with Schizophrenia: Subjects with a current diagnosis of schizophrenia, as defined by DSM-IV-TR criteria (and confirmed by the K-SADS-PL for de novo subjects only), and a history of the illness (diagnosis or
    symptoms) for at least 6 months prior to screening (as per subject, family, or healthcare provider, or by previous medical records). Schizophrenia must be the primary DSM-IV-TR axis I diagnosis. The diagnosis of schizophrenia must be made and documented initially by an adequately trained clinician (eg, adolescent psychiatrist or local medical equivalent). For de novo subjects, the diagnosis should be confirmed by utilizing the K-SADSPL performed by an adequately trained clinician once at the time of the entry into Study 267. If a rollover subject does not have a completed K-SADS-PL assessment from Study 266, then this assessment must be completed at Screening for Study 267.
    Subjects with Bipolar Manic or Mixed Episode:
    Subjects with a current diagnosis of Bipolar I disorder, manic or mixed episode with or without psychotic features experiencing symptoms at least for a week, as defined by
    Axis I (DSM-IV-TR) criteria, confirmed by K-SADS-PL, and have a Young Mania Rating Scale (YMRS) score ≥ 20 at Baseline.

    4. Subjects who, in the investigator’s judgment, require treatment with antipsychotic medication(s).

    5. Subjects who have shown previous response to antipsychotic treatment (other than clozapine) and are not resistant to treatment with other antipsychotics, according
    to the investigator’s clinical judgment.

    6. Subjects who are currently being treated with oral antipsychotics other than clozapine, and subjects who are not resistant to treatment with other antipsychotics. De novo subjects who have been without antipsychotic treatment for no more than 3 weeks prior to screening will be considered as being treated currently for the purpose of determining eligibility for this trial.

    7. Inpatient or outpatient status, with the exception of acute hospitalization due to psychiatric reasons at the time of screening or before Phase 2. Subjects who rollover from Study 266 who meet the criteria for impending relapse are
    exempt from this criteria.

    8. Ability of the subject and the subject’s parent/guardian or legally acceptable representative, as applicable for local laws, to comprehend and satisfactorily comply with the protocol requirements (including the prescribed dosage regimens, tablet ingestion, and discontinuation of prohibited concomitant medications), to read and understand the written word in order to complete subject reported outcomes measures, and to reliably rate assessment scales.

    9. Females of childbearing potential must have a negative pregnancy test, must be practicing acceptable double barrier methods of contraception (or can confirm abstinence), and must not be pregnant or lactating.

    10. Subjects who are receiving antipsychotic(s) other than aripiprazole or clozapine must be cross-titrated to study aripiprazole monotherapy over 4 to 6 weeks using an initial dose of 2 mg/day in Phase 1 to achieve a recommended aripiprazole monotherapy minimum target dose of 10
    mg/day after Day 6 in order to enter Phase 2, but higher doses may be achieved based on the subject’s clinical need and investigator.

    The full list of inclusion criteria at screening plus Inclusion Criteria Assessed Prior to Entry into Phase 1 and Inclusion Criteria Assessed Prior to Entry into Phase 2 are described in the study protocol.
    E.4Principal exclusion criteria
    ALL SUBJECTS:
    1) Sexually active males who are not practicing doublebarrier birth control or who will not remain abstinent during the study and for 90 days following the last dose of
    study medication, or sexually active females of childbearing potential who are not practicing doublebarrier birth control or who will not remain abstinent during the study and for 30 days following the last dose of study medication. Abstinence will be permitted if it is confirmed and documented at every study visit. If employing birth control, two of the following precautions must be used: vasectomy, tubal ligation, vaginal diaphragm, intrauterine device (IUD), birth control pill, birth control depot injections, implant, condom or sponge with spermicide.

    2) Females who are breast-feeding and/or who have a positive serum pregnancy test result prior to receiving study drug.

    Target Disease
    3) All Subjects: Axis I (DSM-IV-TR) diagnosis for schizoaffective disorder, autism, pervasive developmental disorder (PDD), OCD, or PTSD.
    Subjects with Schizophrenia: Subjects with a current major depressive episode.
    Subjects with Bipolar Manic or Mixed Episode: Subjects presenting with a clinical picture and/or history that is consistent with an Axis I (DSM-IV-TR) diagnosis of Bipolar II Disorder or Bipolar Disorder not otherwise specified (NOS).

    4. Subjects with a clinical presentation and/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 (ie, medication, illicit drug use, etc.).

    5. Any neurological disorder, with the exception of Tourette’s syndrome.

    6. Subjects experiencing symptoms consistent with a major depressive episode at the time of screening other than subjects diagnosed with Bipolar I Disorder Mixed Episode.

    7. Subjects with schizophrenia or Bipolar Manic or Mixed Episode that is considered treatment resistant to antipsychotic medication, including relapse while on adequate doses of aripiprazole, by history.

    8. Subjects who are currently receiving clozapine or have received clozapine, regardless of dose or duration, at any time in the past are ineligible for entry into the study.

    9. Subjects who have a significant risk of committing suicide based on history (eg, suicide attempt in the past 1 year) or routine psychiatric status examination, or who
    have an answer of “yes” on Questions 4 or 5 (current or over the last 30 days) on the suicidal ideation section of the baseline screening version of the C-SSRS.

    10. Subjects who have met DSM-IV-TR criteria for substance dependence within the past 180 days prior to screening.

    11. Subjects who have epilepsy, a history of seizures, or a history of severe head trauma or stroke, or have a history or current evidence of other unstable medical conditions that would expose them to undue risk of a significant AE or interfere with assessments of safety or efficacy during the course of the trial, including but not limited to hepatic, renal, respiratory, cardiovascular, endocrine, neurologic, hematologic, or immunologic disease as determined by the clinical judgment of the investigator; subjects with a comorbid serious systemic illness that requires pharmacotherapy.

    12. Subject with a history of subclinical hypothyroidism (TSH ≥4 mIU/L), known hypothyroidism or hyperthyroidism (unless condition has been stabilized with medications).

    13. Subjects who have a medical history of uncontrolled diabetes, labile or unstable diabetes (brittle diabetes), newly diagnosed diabetes, or clinically significant abnormal blood glucose levels (defined as fasting blood glucose ≥ 125 mg/dL). If the result is abnormal, then hemoglobin A1c (HbA1c) testing will automatically be performed. If the HbA1c is ≥ 7%, at screening the subject must be withdrawn and considered a screen failure. At any time during the study, including screening, if a subject’s fasting blood glucose levels are abnormal (≥ 125 mg/dL), then fasting blood glucose testing must be repeated.

    14) Subjects who have a positive drug screen for cocaine or cannabis during screening are ineligible. (Subjects who fail the drug screen can be rescreened one additional time within the 42 day screening period. If they pass the second drug screen test they may be enrolled. They may not have a third repeated drug screen during the screening period. Subjects who have two consecutive positive drug screens for cocaine at any time during the study must be withdrawn from the study. Two positive drug screens for other drugs of abuse must be discussed with the medical monitor at anytime during the study and prior to entry into Phase 1 or Phase 2 unless the subject satisfies criteria for dependence, in which case the subject should be withdrawn from the
    study.

    A full list of Other Exclusion Criteria is contained in the protocol.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Endpoint:
    • The frequency and severity of AEs, SAEs (clinical and laboratory), and discontinuation from study due to AEs
    E.5.1.1Timepoint(s) of evaluation of this end point
    Throughout the duration of the study (max 12 months for rollover subjects)

    Throughout the duration of the study (max 24 months for Denovo subjects)
    E.5.2Secondary end point(s)
    Safety:
    • Mean change from baseline and incidence of clinically significant abnormalities in clinical laboratory tests and urinalysis results (including fasting blood lipids, glucose and insulin, serum prolactin, HbA1c and creatinine phosphokinase [CPK]), vital signs (supine and standing positions) and ECG parameters. A central ECG service will be utilized to review all ECGs in order to standardize interpretations for the safety analysis.
    • Review of physical examination findings
    • Mean change from baseline of z-scores for height and body weight, mean changes of BMI and waist circumference
    • Mean change from baseline on the AIMS, SAS, and BARS
    • The frequency of symptom items for the clinician-administered New York Assessment for Adverse Cognitive Effects of Neuropsychiatric Treatment: (NY-AACENT).
    • Baseline and postbaseline Tanner Staging
    • Analysis of potential suicide events recorded on the C-SSRS
    • Time to discontinuation due to AE

    Efficacy:
    Schizophrenia:
    • Mean change from baseline in PANSS Total Score
    • Mean change from baseline in PANSS Positive and Negative subscales
    • Mean change from baseline in CGI-S score
    • Mean CGI-I score at endpoint
    • Mean change from baseline in CGAS
    Bipolar Manic or Mixed Episode:
    • Mean change from baseline in YMRS
    • Mean change from baseline in CGI-BP Severity
    • Mean CGI-BP Improvement score at endpoint
    • Mean change from baseline in GBI
    • Mean change from baseline in ADHD-RS-IV
    • Mean change from baseline in CGAS

    Other Outcomes:
    • Change from baseline for P-QLES-Q
    • Mean change from baseline on the PANSS Cognitive Subscale Score
    • Time to discontinuation for all reasons
    E.5.2.1Timepoint(s) of evaluation of this end point
    Throughout the duration of the study (max 12 months for rollover subjects)

    Throughout the duration of the study (max 24 months for Denovo subjects)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    long-term safety and tolerability
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Bulgaria
    Croatia
    Hungary
    India
    Malaysia
    Philippines
    Poland
    Romania
    Russian Federation
    Serbia
    Taiwan
    Ukraine
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The last visit of the last subject.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 344
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 3
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 341
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 6
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 300
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Following the end of study treatment, subjects will be prescribed appropriate antipsychotic treatment and will be followed-up for safety reasons. Antipsychotic medications should be carefully titrated to higher doses as needed to achieve adequate efficacy while maintaining tolerability.

    All subjects will be followed up for safety reasons via telephone 30 days (± 3 days) after the last study visit. AEs will be recorded, including any associated concomitant
    medications.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2011-06-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-09-08
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2014-04-25
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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