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    Summary
    EudraCT Number:2007-000576-16
    Sponsor's Protocol Code Number:R076477PSZ3001
    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 number2007-000576-16
    A.3Full title of the trial
    A Randomized, Multicenter, Double-Blind, Weight-Based, Fixed-Dose,
    Parallel-Group, Placebo-Controlled Study of the Efficacy and Safety of
    Extended Release Paliperidone for the Treatment of Schizophrenia in
    Adolescent Subjects, 12 to 17 Years of Age
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Double-blind, Placebo-controlled Study of the Safety and Efficacy of
    Paliperidone Extended Release (ER) in the Treatment of Schizophrenia in
    Adolescent Patients
    A.4.1Sponsor's protocol code numberR076477PSZ3001
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00518323
    A.5.4Other Identifiers
    Name:Original Study ID:Number:CR002368
    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.3.8 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 number12
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    D.8.4Route of administration of the placeboOral use
    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 10008525
    E.1.2Term Childhood schizophrenia
    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 is to evaluate the efficacy, safety and tolerability of three weight-based, fixed-dose groups of paliperidone ER (to fully explore the tolerability range) as
    compared with placebo in adolescent subjects 12 to 17 years of age, inclusive, with schizophrenia.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to:
    • Assess the change in the global impression of severity of illness
    associated with the use of paliperidone ER compared with placebo 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 compared with placebo as measured by the Children's Global Assessment Scale (CGAS).
    • Explore the pharmacokinetics of paliperidone ER and the relationship between its pharmacokinetics and the results of the efficacy parameters (e.g., Positive and Negative Syndrome Scale [PANSS]) and safety parameters (e.g., extrapyramidal symptoms
    [EPS], adverse events) of interest.

    An exploratory secondary objective is to 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
    Males or females between 12 and 17 years of age, inclusive, with a
    body weight of at least 29 kg, who met the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM IV) criteria for schizophrenia at least 1 year before screening and who had a PANSS total score between 60 and 120, inclusive, at screening and baseline. Eligible subjects were otherwise physically healthy based on medical history, physical examination, electrocardiogram (ECG), and laboratory
    test results.
    E.4Principal exclusion criteria
    • Subjects who, at screening, met the DSM-IV criteria for dissociative disorder, bipolar disorder, major depressive disorder, schizoaffective disorder, schizophreniform disorder, autistic disorder, or primary substance-induced psychotic disorder.
    • Subjects with mild, moderate, or severe mental retardation (ie,
    documented intelligence quotient [IQ] <70), established by previous IQ testing or history;
    • History or presence of circumstances that could have increased the risk of the occurrence of torsade de pointes or sudden death in
    association with the use of drugs that prolong the QT interval corrected for heart rate (QTc)
    E.5 End points
    E.5.1Primary end point(s)
    Primary Outcome Measures:
    •Change in the PANSS Total Score From Baseline to the Last
    Postrandomization Assessment in the Double-blind Period of the
    Study. The Positive and Negative Syndrome Scale (PANSS) measures the severity of psychotic symptoms of schizophrenia. Scores range from 30 to 210, where 30=best and 210=worst. The change in PANSS total score for all eligible subjects was measured from the beginning of the study to the end.
    E.5.1.1Timepoint(s) of evaluation of this end point
    According to time and events schedule over 6 week duration of study
    E.5.2Secondary end point(s)
    Secondary Outcome Measures:
    •Change From Baseline to End Point in Clinical Global Impression-
    Severity (CGI-S) Scale
    The CGI-S rating scale was used to assess the severity of a subject's overall clinical condition. Scores range from 1 to 7, where 1=best and 7=worst.
    •Change From Baseline to End Point in Children's Global Assessment (CGAS) Score
    The CGAS score assesses psychological, social, and school functioning for children 6 to 17 years of age. Scores range from 1 to 100, where 100=best and 1=worst.
    •Change From Baseline to End Point in Sleep Visual Analog Scale (VAS) for Quality of Sleep.
    The sleep VAS for sleep quality is a scale for measuring the quality of sleep experienced by a patient. Scores range from 0 to 100, where 100=best and 0=worst.
    •Change From Baseline to End Point in Sleep VAS for Daytime
    Drowsiness
    The sleep VAS for daytime drowsiness is a scale for measuring the
    drowsiness experienced by a patient. Scores range from 0 to 100,
    where 100=best and 0=worst.
    E.5.2.1Timepoint(s) of evaluation of this end point
    According to time and events schedule over 6 week duration of study
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    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
    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 last subject undergoing 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: 201
    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: 201
    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 must give an assent to participate before screening procedures began. Subjects who did not give assent to participate were not to be included in the study;

    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 201
    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)
    For subjects not entering the open-label study, a follow-up visit will be scheduled 1 week after completion of the study or upon early discontinuation to monitor for adverse events.
    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: India
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