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    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2005-005345-19
    Sponsor's Protocol Code Number:R076477BIM3003
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-05-10
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2005-005345-19
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group,
    Multicenter Study to Evaluate the Efficacy and Safety of Flexibly-Dosed
    Extended-Release Paliperidone as Adjunctive Therapy to Mood Stabilizers in
    the Treatment of Acute Manic and Mixed Episodes Associated with Bipolar I
    Disorder
    A.3.2Name or abbreviated title of the trial where available
    Efficacy/safety of Paliperidone OROS combined with mood stabilizers in Bipolar I Disorder
    A.4.1Sponsor's protocol code numberR076477BIM3003
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorJanssen-Cilag International N.V.
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Information not present in EudraCT
    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 3 mg overencapsulated tablets
    D.3.2Product code F022
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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.3.9.2Current sponsor codeR076477
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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 Information not present in EudraCT
    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 9 mg overencapsulated tablets
    D.3.2Product code F023
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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.3.9.2Current sponsor codeR076477
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number9
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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 placeboTablet
    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
    Bipolar I Disorder
    MedDRA Classification
    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 objectives of this study are to demonstrate the antimanic efficacy and to assess the safety and tolerability of paliperidone ER relative
    to placebo during 6 weeks of treatment in subjects with Bipolar I Disorder who experience an acute manic or mixed episode (with or without psychotic features) while they are taking lithium or valproate for treatment of Bipolar I Disorder.
    E.2.2Secondary objectives of the trial
    To assess the effect of paliperidone ER on global functioning compared with placebo during 6 weeks of treatment. Other objectives of this study include:
    " To assess the onset of antimanic clinical response to paliperidone ER compared with placebo.
    " To assess the global improvement in severity of illness associated with the use of paliperidone ER compared with placebo.
    " To evaluate the impact of paliperidone ER therapy on health-related functional status, using the Short Form (SF-36), compared with placebo.
    " To assess the impact of paliperidone ER on depressive symptoms compared with placebo.
    " To assess the impact of paliperidone ER on psychotic symptoms compared with placebo using a symptom-rating scale.
    " To explore the pharmacokinetics of paliperidone ER in subjects with Bipolar I Disorder and assessing the relationship of pharmacokinetics to the efficacy and safety of paliperidone ER.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1- Man or woman, between 18 (or the minimum age to provide informed consent in the jurisdiction in which the study is taking place, whichever is older) and 65 years of age, inclusive.
    2- Subjects must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and
    are willing to participate in the study. Note: It is acceptable to have additional signatures if required by local regulations.
    3- In countries where health authorities have approved the pharmacogenomic testing, subjects must have signed the informed consent form for pharmacogenomic testing indicating whether they do or do not agree to participate in the genetic part of the study. NOTE: Participation in the genetic testing component is not mandatory for participation in the study
    4- Meet DSM-IV criteria for Bipolar I Disorder, Most Recent Episode Manic or Mixed (with or without psychotic features) at the time of screening/washout (Days -7 to -1). Subjects with other Axis I and II disorders, except those listed in the exclusion criteria, are also acceptable. All diagnoses will be confirmed by the MINI.
    5- Subjects must have been taking the mood stabilizers, lithium or valproate, as part of treatment for Bipolar I Disorder for a minimum of 2 weeks before screening. At screening, the drug levels of subjects on lithium and valproate should be within the therapeutic range (0.6-1.2 mEq/L and 50-125 µg/mL, respectively). For subjects on lithium, documentation should be available of therapeutic drug levels from the period between 2 months and 2 weeks before screening. The dosage of lithium should not have changed in the period between the therapeutic drug monitoring and screening. For subjects on valproate, the dosage of the mood stabilizer should not have been changed over a period of at least 2 weeks before screening.
    6- History of at least 1 previously documented manic or mixed episode requiring medical treatment within the 3 years before the screening/washout phase.
    7- Total score of at least 20 on the YMRS at screening and at baseline (Day 1).
    8- Women must be postmenopausal (no spontaneous menses for at least 2 years), surgically sterile, abstinent, or, agree to practice an effective
    method of birth control if they are sexually active before entry and throughout the study (effective methods of birth control include prescription hormonal contraceptives, intrauterine device, double-barrier method, and male partner sterilization).
    9- Able and willing to comply with self-administration of medication, or have consistent help or support available.
    10- Able to meet study requirements (e.g., answer self-administered questionnaires). NOTE: If a subject is unable to read study information or answer study questions, study personnel may read the questions to the subject and the subject may then mark his or her choice.
    E.4Principal exclusion criteria
    1- In the opinion of the investigator, are at significant risk for suicidal or violent behavior during the course of the study.
    2- Meet DSM-IV criteria for any type of episode associated with bipolar disorder other than Bipolar I Disorder, Most Recent Episode Manic or Mixed (with or without psychotic features).
    3- Meet DSM-IV criteria for rapid cycling and schizoaffective disorder.
    4- Known or suspected borderline or antisocial personality disorder.
    5- Known or suspected history of substance dependence (excluding nicotine and caffeine) according to DSM-IV criteria, with DSM-IV duration
    criteria modified to at any time within the previous 3 months.
    6- Serious or unstable, medical illness or have a history of cerebrovascular disease or uncontrolled or insulin dependent diabetes mellitus. Subjects with chronic illness may be included but must be stable and otherwise physically healthy.
    7- Known or suspected seizure disorder or require treatment with anticonvulsants for another indication (except for valproate).
    8- History of severe pre-existing gastrointestinal narrowing or inability to swallow oral study drug whole with the aid of water.
    9- Results at screening or baseline for ALAT or ASAT greater than twice the upper limit of the central laboratory's reference range. If the results for any other serum chemistry, hematology, or urinalysis testing are not within the central laboratory's reference ranges, the subject can be enrolled only if, in the opinion of the investigator, the deviations are not clinically significant.
    10- Have active hypo- or hyperthyroidism unless stabilized on appropriate medication for at least 3 months before the screening/washout phase.
    11- History of neuroleptic malignant syndrome or similar encephalopathic syndrome.
    12- Have a moderate-to-severe degree of tardive dyskinesia at screening.
    13- Known or suspected history of hypersensitivity or intolerance to paliperidone, risperidone, lithium, or valproate; or suspected history of life-threatening drug allergy or hypersensitivity to any drug.
    14- Have received benzodiazepines at doses equivalent to 4 mg/day of lorazepam or higher for a period of 3 months or longer immediately before the screening/washout phase.
    15- Use of clozapine, aripiprazole, or fluoxetine within 1 month before the screening/washout phase.
    16- Have received antidepressant therapy, other than fluoxetine, within 7 days (or 5 times the half-life of the product, whichever is longer) before study drug administration on Day 1. Antidepressant medications include known antidepressants used for other indications as well as St. John's Wort, SAM-e, and other over-the-counter (OTC) antidepressants.
    17- Use of antiparkinsonian drugs or beta-adrenergic blockers (for any indication other than hypertension) within 3 days before study drug
    administration on Day 1.
    18- Have used cocaine, phencyclidine, amphetamine, methylphenidate, pemoline, an opioid (excluding low-dose codeine), hallucinogen, or any other drug that may be associated with manic symptoms as evidenced by a positive urine drug screen.
    19- Alcohol intoxication within 3 days before study drug administration on Day 1.
    20- Have had an injection of RISPERDAL CONSTA within 5 weeks before the screening/washout phase, or have received another depot antipsychotic within 1 treatment cycle before the screening/washout phase.
    21- Have received an experimental drug or used an experimental medical device within 3 months before the screening/washout phase.
    22- Electroconvulsive therapy within 6 months before study drug administration on Day 1.
    23- Women who are pregnant or nursing.
    24- Have an anticipated life expectancy of 6 months or less.
    25- Unable to provide their own consent.
    26- Previous participation in this study.
    E.5 End points
    E.5.1Primary end point(s)
    primary efficacy end point is the change in the total YMRS score from baseline to the last post-baseline assessment during 6 weeks of treatment.
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    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.8.3 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.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months2
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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) No
    F.1.2Adults (18-64 years) Yes
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2006-05-10. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 296
    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 Decision2006-05-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-07-25
    P. End of Trial
    P.End of Trial StatusCompleted
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