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    The EU Clinical Trials Register currently displays   43935   clinical trials with a EudraCT protocol, of which   7309   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:2005-000016-27
    Sponsor's Protocol Code Number:CL2-33138-007
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-04-25
    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 ConcernedGermany - BfArM
    A.2EudraCT number2005-000016-27
    A.3Full title of the trial
    Safety and efficacy of S 33138 versus risperidone in schizophrenic patients with predominant positive symptoms:
    A pilot phase IIa, international, multicentre, randomised, double-blind, parallel-group, controlled study.
    A.3.2Name or abbreviated title of the trial where available
    CL2-33138-PO-C-RISP-160P-SCHIZOPHRENIA
    A.4.1Sponsor's protocol code numberCL2-33138-007
    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 SponsorInstitut de Recherches Internationales Servier
    B.1.3.4CountryFrance
    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
    B.Sponsor: 2
    B.1.1Name of SponsorLaboratorios Servier S.L. (For Spain only)
    B.1.3.4CountrySpain
    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
    B.Sponsor: 3
    B.1.1Name of SponsorSERVIER Research and Development ICTR (For United Kingdom only)
    B.1.3.4CountryUnited Kingdom
    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.3.2Product code S33138-F34
    D.3.4Pharmaceutical form Capsule, hard
    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.3.9.2Current sponsor codeS33138
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    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) 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.3.2Product code S33138-F35
    D.3.4Pharmaceutical form Capsule, hard
    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.3.9.2Current sponsor codeS33138
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    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) 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: 3
    D.1.2 and D.1.3IMP RoleComparator
    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.2.1.1.1Trade name RISPERDAL
    D.2.1.1.2Name of the Marketing Authorisation holderJANSSEN-CILAG
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameRisperidone
    D.3.4Pharmaceutical form Capsule, hard
    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 INNrisperidone
    D.3.9.1CAS number 106266-06-2
    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) 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 placeboCapsule, hard
    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
    Schizophrenia
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 7.0
    E.1.2Level P.T.
    E.1.2Classification code 10039626
    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 pilot study is to assess the clinical and biological safety of S 33138 after 8 weeks of oral administration in schizophrenic patients with predominant positive symptoms.
    E.2.2Secondary objectives of the trial
    The secondary objectives are:
    - to assess the efficacy of S 33138,
    - to get an evaluation of patient’s subjective well-being,
    - to assess the pharmacokinetics of S 33138 and S 35424.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Selection criteria :
    - Male or female, aged between 18 and 65 years old (inclusive),
    - Hospitalised for an acute first episode or a relapse of schizophrenia paranoid or undifferentiated types or provisional schizophreniform disorder or schizoaffective disorder .
    - Patients with a total score of at least 60 for the 30-item PANSS, a score of at least 4 on three or more items of the PANSS positive subscale, a (PANSS positive subscale score - PANSS negative subscale score) > 0 and with a CGI severity of illness score of at least 4.

    Inclusion criteria :
    - Patients with a total score of at least 60 for the 30-item PANSS (scoring 1-7), a score of at least 4 on three or more items of the PANSS positive subscale, a (PANSS positive subscale score - PANSS negative subscale score) >0,
    - Patients with a CGI Severity of Illness score of at least 4 (moderately ill),
    - Normal results (or judge by the investigator as clinically not significant) for physical examination and vital signs.
    E.4Principal exclusion criteria
    Non-selection criteria - General criteria :
    - Pregnant or breast feeding women,
    - Women of childbearing potential or women who have been post menopausal for less than 2 years without effective contraception (protected by oral contraception or intra-uterine device or any other method judged by the investigator to be adapted to the patient’s condition),

    Non-selection criteria - Medical and therapeutic :
    - Patients presenting DSM-IV-TR criteria for any other psychotic disorder such as:
    . schizophrenia disorganised type (295.10), catatonic type (295.20) and residual type (295.60),
    . delusional disorder (297.1), brief psychotic disorder (298.8), shared psychotic disorder (297.3), substance-induced psychotic disorder and psychotic disorder NOS (298.9),
    - Patients with ongoing or previous recurrent disease of the central nervous system, especially convulsive disorders or epilepsy, depression, generalised anxiety disorder, mental retardation, brain tumor, delirium, dementia,
    - Patients with a history of not responding to risperidone or who have not responded to risperidone for the present episode,
    - Patients having a known hypersensitivity to risperidone,
    - Patients with a history of neuroleptic malignant syndrome,
    - Patients having received long-acting intramuscular neuroleptic medication or barbiturates within 4 weeks before the selection visit,
    - Patients treated with fluoxetine, lithium, valproate, valpromide, carbamazepine, phenytoine within 15 days preceding the selection visit,
    - Patients treated with antidepressants other than fluoxetine within six days before the selection visit,
    - Patients simultaneously treated with two or more QT/QTc interval prolonging drugs and/or two or more concomitant treatments which are CYP 2D6 substrates or inhibitors, and/or 2C19 and/or 3A4 inhibitors, which cannot be stopped and/or must be maintained during the study,
    - Patients resistant to antipsychotic treatment defined as failure to respond to at least 3 periods of treatment lasting at least 6 weeks in the preceding 5 years with antipsychotics from at least 2 different chemical classes at maximum effective dosages (e.g. 300 mg per day of chlorpromazine or 20 mg per day of haloperidol or 8 mg per day of risperidone or 15 mg per day of olanzapine), and with no period of relatively good functioning within the previous 5 years,
    - Patients who are non responders for the present psychotic episode defined as failure to respond to at least two different adequate antipsychotic treatments, during 3 weeks at an adequate dose,
    - Patients with previous or present history of severe or uncontrolled cardiovascular, pulmonary, infectious, autoimmune, renal, hepatic, gastro-intestinal, ophthalmologic, endocrine, blood disease or cancer,
    - Patients with severe or uncontrolled arterial hypertension,
    - Patients with a known moderate to severe hepatic or renal insufficiency,
    - Patients having a known glucose intolerance or diabetes type I or II,
    - Patients with a known lactose intolerance,
    - Patients with congestive or ischemic heart disease or infarction,
    - Patients with a known personal or family history of Long QT Syndrome,
    - Patients with history of extreme and/or repeated violence or judged by the investigator to be at risk of suicide or homicide,
    - Patients with presence of alcohol or drug abuse or addiction.

    Non-inclusion criteria :
    - Patients having significant abnormalities seen with the 12-lead ECG as: QTc > 450 ms, AVBIIb, AVBIII, repeated sequences of 3 or more consecutive VES, or any other disorder judged by the investigator as clinically significant,
    - Patients having biological results [haematology, blood biochemistry, endocrinology and urinalysis (glucose, protein, acetone)] out of the normal range and judged by the investigator as clinically significant,
    - With positive urinary drug screening: opiates, barbiturates, amphetamines, cocaine (except benzodiazepines and cannabinoids),
    - With positive blood alcohol level,
    - With positive serology tests (Hbs antigen, anti-HCV antibodies). However, if results are not yet available at the time of the inclusion and if the other hepatic biological results are normal, patients can be included according to investigator's judgement.
    E.5 End points
    E.5.1Primary end point(s)
    The safety criteria are:
    - Adverse events,
    - Simpson-Angus scale total score,
    - Barnes Akathisia scale,
    - UKU side effect rating scale ,
    - ECG parameters issued from the central reading of ECG tracings,
    - ECG abnormalities issued from the central reading of ECG tracings,
    - Supine Blood pressure [SBP (mmHg) and DBP (mmHg)] and Heart rate (bpm),
    - Body temperature (°C) and Body weight (kg),
    - Laboratory parameters.

    The efficacy criteria are:
    - Positive And Negative Syndrome Scale (PANSS) total score,
    - PANSS positive subscale score,
    - PANSS negative subscale score,
    - PANSS-derived Brief Psychiatric Rating Scale (BPRS) score,
    - Clinical Global Impression (CGI) Severity of Illness score, CGI Global Improvement score, CGI Efficacy Index,
    - Response to treatment defined as a decrease from baseline > or = 20% of the PANSS total score and a CGI Global Improvement equal to 1 (very much improved) or 2 (much improved),
    - Response to treatment defined as a decrease from baseline > or = 30% of the PANSS positive subscale score and a CGI Global Improvement equal to 1 (very much improved) or 2 (much improved).
    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 No
    E.6.10Pharmacogenetic Information not present in EudraCT
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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) Yes
    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.8.5The 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 years
    E.8.9.1In the Member State concerned months12
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months12
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 2005-04-25. 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    - Patients hospitalised in acute phase could not be able yet to give their consent personally, in this case, a legal representative or a witness, will give previously their consent.
    - ­Women of childbearing potential with effective contraception.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 134
    F.4.2.2In the whole clinical trial 160
    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 Decision2005-06-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-07-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2006-10-06
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