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    Summary
    EudraCT Number:2015-001221-16
    Sponsor's Protocol Code Number:RISSCH3024
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2015-03-31
    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 number2015-001221-16
    A.3Full title of the trial
    A Prospective Study of the Clinical Outcome Following Treatment Discontinuation After Remission in First-Episode Schizophrenia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Follow-Up Study of Schizophrenic Participants Following Treatment Discontinuation After Remission From a First Psychotic Episode
    A.4.1Sponsor's protocol code numberRISSCH3024
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorJanssen Cilag N.V./S.A
    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 EMEA Medical Affairs
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen Research and Development
    B.5.2Functional name of contact pointClinical Registry Group-JB BV
    B.5.3 Address:
    B.5.3.1Street AddressArchimedesweg 29
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333CM
    B.5.3.4CountryNetherlands
    B.5.6E-mailClinicalTrialsEU@its.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 RISPERDAL
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen Pharmaceutical K.K.
    D.2.1.2Country which granted the Marketing AuthorisationJapan
    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.3.4Pharmaceutical 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 INNRISPERIDONE
    D.3.9.3Other descriptive nameRISPERIDONE
    D.3.9.4EV Substance CodeSUB10335MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    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) 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 RISPERDAL CONSTA
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen Pharmaceutical K.K.
    D.2.1.2Country which granted the Marketing AuthorisationJapan
    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.3.4Pharmaceutical form Powder and solvent for prolonged-release suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRISPERIDONE
    D.3.9.3Other descriptive nameRISPERIDONE
    D.3.9.4EV Substance CodeSUB10335MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number50
    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
    E.1.1.1Medical condition in easily understood language
    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 17.1
    E.1.2Level PT
    E.1.2Classification code 10039626
    E.1.2Term 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 purpose of this study is to evaluate the outcome of medication discontinuation, the safety and effectiveness of re-initiating risperidone long acting injection (RLAI) in case of relapse (the return of a medical problem) of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) during the study observation period of 36 months.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Participants who completed 24 months RIS-PSY-301 study
    - Surgically sterile female participants or practicing an effective method of birth control before entry and throughout the study; and must have shown a negative urine serum pregnancy test at baseline before study entry
    - Participants who have signed informed consent document
    E.4Principal exclusion criteria
    - Participants requiring treatment with mood stabilizers or antidepressants at study entry
    - Participants with evidence of alcohol or drug abuse or dependence (except for nicotine and caffeine dependence) according to Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria diagnosed in the last month before entry
    - Participants with a history of severe drug allergy, drug hypersensitivity, or neuroleptic malignant (cancerous) syndrome
    - Participants with known hypersensitivity to risperidone
    - Participants with acute risk of suicide at study entry or a history of suicidal attempt(s)
    E.5 End points
    E.5.1Primary end point(s)
    - Time to Relapse After Discontinuation of Risperidone Long-Acting Injection (RLAI) in First-Episode Participants Successfully Treated for 24 Months With RLAI in Previous Study (RIS-PSY-301) (Period 1)
    - Percentage of Participants who Relapsed After Discontinuation of RLAI (Period 1)
    - Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score After Re-Initiation of RLAI, at Month 24 or EW (Period 2)
    - Time to Treatment Response After Re-Initiation of RLAI (Period 2)
    E.5.1.1Timepoint(s) of evaluation of this end point
    - Month 36 or early withdrawal (EW)
    - Month 36 or EW
    - Baseline and Month 24 or EW
    - Month 24 or EW
    E.5.2Secondary end point(s)
    - Change From Baseline in PANSS Total Score and Subscales of PANSS at Month 36 or EW (Period 1)
    - Change From Baseline in PANSS Total Score and Subscales of PANSS at Month 24 or EW (Period 2)
    - Change From Baseline in Marder PANSS Subscales Score at Month 36 or EW (Period 1)
    - Change From Baseline in Marder PANSS Subscales Score at Month 24 or EW (Period 2)
    - Number of Participants With Disease Remission Based on PANSS (Period 1)
    - Number of Participants With Disease Remission Based on PANSS (Period 2)
    - Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Month 36 or EW (Period 1)
    - Clinical Global Impression of Change (CGI-C) Score at Month 36 or EW (Period 1)
    - Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Month 24 or EW (Period 2)
    - Clinical Global Impression of Change (CGI-C) Score in Period 2 at Month 24 or EW (Period 2)
    - Change From Baseline in Calgary Depression Scale Score for Schizophrenia (CDSS) at Month 36 or EW (Period 1)
    - Change From Baseline in Calgary Depression Scale Score for Schizophrenia (CDSS) at Month 24 or EW (Period 2)
    - Change From Baseline in Social and Occupational Functioning Assessment Scale (SOFAS) Score at Month 36 or EW (Period 1)
    - Change From Baseline in Social and Occupational Functioning Assessment Scale (SOFAS) Score at Month 24 or EW (Period 2)
    - Change From Baseline in Patient Global Impression-Severity (PGI-S) Score at Month 36 or EW (Period 1)
    - Patient Global Impression-Change (PGI-C) Score at Month 36 or EW (Period 1)
    - Change From Baseline in Patient Global Impression-Severity (PGI-S) Score at Month 24 or EW (Period 2)
    - Patient Global Impression-Change (PGI-C) Score at Month 24 or EW (Period 2)
    - Change From Baseline in 12-Item Short-Form (SF-12) Score - Quality of Life Survey at Month 36 or EW (Period 1)
    - Change From Baseline in 12-Item Short-Form (SF-12) Score - Quality of Life Survey at Month 24 or EW (Period 2)
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Baseline and Month 36 or EW
    - Baseline and Month 24 or EW
    - Baseline and Month 36 or EW
    - Baseline and Month 24 or EW
    - Month 36 or EW
    - Month 24 or EW
    - Baseline and Month 36 or EW
    - Month 36 or EW
    - Baseline and Month 24 or EW
    - Month 24 or EW
    - Baseline and Month 36 or EW
    - Baseline and Month 24 or EW
    - Baseline and Month 36 or EW
    - Baseline and Month 24 or EW
    - Baseline and Month 36 or EW
    - Month 36 or EW
    - Baseline and Month 24 or EW
    - Month 24 or EW
    - Baseline and Month 36 or EW
    - Baseline and Month 24 or EW
    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 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 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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    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.8.2.4Number of treatment arms in the trial2
    E.8.3 Will this trial be conducted at a single site globally? Yes
    E.8.4 Will this trial be conducted at multiple sites globally? No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    South Africa
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years4
    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: 33
    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: 33
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 33
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Patients aged between 17-47 years of age.
    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 33
    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)
    None
    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: South Africa
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