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    The EU Clinical Trials Register currently displays   41230   clinical trials with a EudraCT protocol, of which   6756   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2007-000577-38
    Sponsor's Protocol Code Number:R076477-PSZ-3002
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2012-03-09
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2007-000577-38
    A.3Full title of the trial
    A 2-Year, Open-Label, Single-Arm Safety Study of Flexibly Dosed Paliperidone Extended Release (1.5-12 mg/day) in the Treatment of Adolescents (12 to 17 Years of Age) With Schizophrenia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Open-label Study of Flexible-dose Paliperidone ER (Extended Release) to Treat Adolescent Schizophrenia.
    A.4.1Sponsor's protocol code numberR076477-PSZ-3002
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00488319
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/154/2011
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorJanssen-Cilag International NV
    B.1.3.4CountryBelgium
    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 supportJanssen-Cilag International NV
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen-Cilag International NV, Turnhoutseweg 30, Belgium
    B.5.2Functional name of contact pointMichael B Emanuel
    B.5.3 Address:
    B.5.3.1Street Address50-100 Holmers Farm Way
    B.5.3.2Town/ cityBuckinghamshire
    B.5.3.3Post codeHP12 4DP
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number441494658336
    B.5.5Fax number441494658499
    B.5.6E-mailmemanuel@gcogb.jnj.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 INVEGA prolonged release tablets
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International NV
    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 namepaliperidone ER
    D.3.2Product code F067
    D.3.4Pharmaceutical form Prolonged-release 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 INNPaliperidone
    D.3.9.1CAS number 144598-75-4
    D.3.9.2Current sponsor codeR076477
    D.3.9.3Other descriptive namePALIPERIDONE
    D.3.9.4EV Substance CodeSUB23268
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPaliperidone
    D.3.9.1CAS number 144598-75-4
    D.3.9.2Current sponsor codeR076477
    D.3.9.3Other descriptive namePALIPERIDONE
    D.3.9.4EV Substance CodeSUB23268
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPaliperidone
    D.3.9.1CAS number 144598-75-4
    D.3.9.2Current sponsor codeR076477
    D.3.9.3Other descriptive namePALIPERIDONE
    D.3.9.4EV Substance CodeSUB23268
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    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
    Adolescent Schizophrenia
    E.1.1.1Medical condition in easily understood language
    Adolescent Schizophrenia
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10039629
    E.1.2Term Schizophrenia childhood
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study was to evaluate the long-term (2-year) safety and tolerability of paliperidone ER in at least 100 adolescent subjects (12 to 17 years of age, inclusive) with schizophrenia.
    E.2.2Secondary objectives of the trial
    Exploratory secondary objectives of this study were to:
    • Assess the effect of paliperidone ER on the long-term symptoms of schizophrenia as measured by the changes in Positive and Negative Syndrome Scale for Schizophrenia (PANSS) scores;

    • Assess the global improvement in severity of illness associated with treatment with paliperidone ER as measured by the Clinical Global Impression-Severity (CGI-S) scale;

    • Assess the benefits in psychological, social, and school functioning associated with treatment with paliperidone ER as measured by the Children’s Global Assessment Scale (CGAS);

    • Assess the changes in multiple domains of cognitive functioning associated with treatment with paliperidone ER as assessed by the Measurements and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) cognition assessment battery;

    • Assess the effect on sleep associated with treatment with paliperidone ER as measured by the sleep Visual Analog Scale (VAS).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Must be male or female, between 12 and 17 years of age, inclusive. Subject must meet the DSM-IV criteria for schizophrenia for at least one year. Parents or legal guardians must sign an informed consent and subjects must sign an assent. Subjects must be otherwise physically healthy and have no active or clinically significant medical problems. Subjects must weigh >/=29 kg. Female subjects were capable of pregnancy must take appropriate contraceptive measures or agree to abstinence throughout the duration of the study. Subjects must not be a danger to themselves or others.
    E.4Principal exclusion criteria
    Subjects who meet DSM-IV criteria for a major axis I disorder, mild, moderate, or severe mental retardation, a known or suspected history of substance dependence in the three months preceding screening, or at increased risk for the occurrence of QT prolongation are excluded. Subjects with a known or suspected history of seizure disorder, NMS, TD, IDDM, active malignancy, or a significant or unstable medical illness are excluded. Subjects with a significant abnormality in clinical laboratory tests or ECG are also excluded.
    E.5 End points
    E.5.1Primary end point(s)
    Effect of paliperidone on prolactin on growth and maturation. Effects on lipid levels, body weight and height, waist circumference, ECGs, fasting glucose, insulin, Tanner staging, EPS, sedation, monitoring of psychiatric adverse events (suicide related phenomena, homicidal ideation, depressed mood and worsening of psychosis)
    E.5.1.1Timepoint(s) of evaluation of this end point
    According to a pre-defined time and events schedule over approximate 108 week study duration
    E.5.2Secondary end point(s)
    Assess the effect of paliperidone ER on long-term symptoms of schizophrenia as measured by the changes in the Positive and Negative Syndrome Scale for Schizophrenia (PANSS) scores.
    Assess the effect of paliperidone ER on the long-term symptoms of schizophrenia as measured by the changes in the PANSS negative symptom scale based on Marder factors.
    Assess the global improvement in severity of illness associated with treatment with paliperidone ER as measured by the Clinical Global Impression - Severity (CGI-S) scale.
    Assess the benefits in psychological, social, and school functioning associated with treatment with paliperidone ER as measured by the Children’'s Global Assessment Scale (CGAS).
    Assess the changes in multiple domains of cognitive functioning associated with treatment with paliperidone ER as assessed by the modified Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) assessment battery.
    Assess the effect on sleep associated with treatment with paliperidone ER as measured by the sleep Visual Analog Scale (VAS).
    E.5.2.1Timepoint(s) of evaluation of this end point
    According to a pre-defined time and events schedule over the 108 week study duration
    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 Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    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 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    India
    Korea, Democratic People's Republic of
    Russian Federation
    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
    Last visit of the last subject undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    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: 400
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 400
    F.1.2Adults (18-64 years) No
    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 No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Subject had to give assent to participate before screening procedures began
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 400
    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)
    Posttreatment follow-up visit 1 week after the subject’s final dose of study drug to monitor AEs.
    G. Investigator Networks to be involved in the Trial
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised:
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