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    Summary
    EudraCT Number:2007-002198-30
    Sponsor's Protocol Code Number:EPICURESUB05T02
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-01-17
    Trial 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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2007-002198-30
    A.3Full title of the trial
    A MULTICENTRE RANDOMIZED CONTROLLED TRIAL COMPARING TOPIRAMATE, STIRIPENTOL AND CLOBAZAM AT THE MAXIMAL TOLERATED DOSAGE, AS ADJUNCTIVE THERAPY TO VALPROATE AND CLOBAZAM IN PAEDIATRIC PATIENTS WITH DRAVET`S SYNDROME (SMEI), AND AUXILIARY PHARMACOGENETIC STUDY
    Studio clinico multicentrico, randomizzato, controllato che confronta Topiramato, Stiripentolo e Clobazam al massimo dosaggio tollerato, come terapia aggiuntiva al Valproato e Clobazam in pazienti pediatrici con sindrome di Dravet (SMEI), e studio ausiliare farmacogenetico.
    A.3.2Name or abbreviated title of the trial where available
    EPICURE Sottoprogetto 5 task 2
    A.4.1Sponsor's protocol code numberEPICURESUB05T02
    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 SponsorInserm-ISP Pole Recherches cliniques et thérapeutiques
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    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 Yes
    D.2.1.1.1Trade name stiripentolo
    D.2.1.1.2Name of the Marketing Authorisation holderbiocodex
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberC(2001)4026
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Capsule, hard
    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 INNOther antiepileptics
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number250
    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 Yes
    D.3.11.13.1Other medicinal product typeNon Applicabile
    D.IMP: 2
    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 Yes
    D.2.1.1.1Trade name TOPAMAX
    D.2.1.1.2Name of the Marketing Authorisation holderJANSSEN CILAG SpA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 Capsule, hard
    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 INNTopiramate
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number25
    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 Yes
    D.3.11.13.1Other medicinal product typeNon Applicabile
    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 Yes
    D.2.1.1.1Trade name FRISIUM*30CPS 10MG
    D.2.1.1.2Name of the Marketing Authorisation holderSANOFI-AVENTIS SpA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 Capsule, hard
    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 INNClobazam
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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) 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 Yes
    D.3.11.13.1Other medicinal product typeNon Applicabile
    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
    Dravet Syndrome
    sindrome di Dravet
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10054859
    E.1.2Term Myoclonic epilepsy
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    evaluate the efficacy of STP and TPM, used as an add-on therapy in addition to VPA and CLB used at usual dosages, on the clonic or tonic-clonic seizures in paediatric patients with DravetÂ’s syndrome not adequately controlled with clobazam and valproate, compared to CLB used at the maximal tolerated dosage
    valutare lÂ’efficacia di STP e TPM utilizzati, come terapia aggiuntiva al Valproato e Clobazam utilizzati ai dosaggi standard, nelle crisi cloniche o tonico-cloniche nei soggetti pediatrici affetti da sindrome di Dravet non controllati adeguatamente con Clobazam e Valproato vs Clobazam utilizzato ai massimi dosaggi tollerati
    E.2.2Secondary objectives of the trial
    - Evaluate the efficacy of STP and TPM, used as an add-on therapy in addition to VPA and CLB used at usual dosages, on convulsive status epilepticus (a status epilepticus is defined as a clonic or tonic-clonic seizure lasting more than 15 minutes) in Dravet`s syndrome, compared to CLB used at the maximal tolerated dosage. - Compare the efficacy of STP to that of TPM, used as an add-on therapy in addition to VPA and CLB used at usual dosages, on the clonic or tonic-clonic seizures and convulsive status epilepticus in Dravet`s syndrome. - Evaluate the efficacy of STP and TPM, used as an add-on therapy in addition to VPA and CLB used at usual dosages in other seizure types other than clonic or tonic-clonic, compared to CLB used at the maximal tolerated dosage. - Evaluate the safety of STP and TPM (defined as their toxicity), used as an add-on therapy in addition to VPA and CLB used at usual dosages, in Dravet`s syndrome, compared to CLB used at the maximal tolerated dosage.
    - Valut lÂ’eff di STP e TPM utilizzati in associazione a dosi standard di VPA e CLB,nello stato di epilettico* di paz pediatrici affetti da sindrome di Dravet rispetto a Clobazam utilizzato ai massimi dosaggi tollerati.*crisi clonica o tonico-clonica della durata di oltre 15 minuti.- Confr. lÂ’eff dello STP vs TPM,utilizzati in associazione a dosi standard di VPA e CLB nelle crisi tonico o tonico-cloniche e nello stato di male epilettico convulsivo della sindrome di Dravet.- Valut lÂ’eff di STP e TPM,utilizzati in associazione a dosi standard diVPA e CLB,vs CLB utilizzato al massimo dosaggio in tipologie di crisi diverse da quelle cloniche o tonico-cloniche.- Valut la sicur. di STP e TPM(definita come tossicità propria)utilizzati in associazione a dosi standard di VPA e CLB vs CLB al massimo dosaggio tollerato nella sindrome di Dravet.- Confr. la sicur. di STP vs TPM,utilizzati in associazione a dosi standard di VPA e CLB,nella sindrome di Dravet.- Confr. lÂ’eff di STP e di TPM
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    PHARMACOGENETIC:
    Vers:03
    Date:2010/07/23
    Title:
    Objectives:

    FARMACOGENETICA:
    Vers:03
    Data:2010/07/23
    Titolo:Studio clinico multicentrico, randomizzato, controllato che confronta Topiramato, Stiripentolo e Clobazam al massimo dosaggio tollerato, come terapia aggiuntiva al Valproato e Clobazam in pazienti pediatrici con sindrome di Dravet (SMEI), e studio ausiliare farmacogenetico.
    Obiettivi:Fattori genetici possono influenzare la farmacocinetica e la farmacodinamica dei farmaci, spiegando parzialmente la variabilita` inter-idividuale. L’identificazione di alcuni polimorfismi genetici ancor prima di iniziare un trattamento potrebbero esitare in una migliore efficacia e sicurezza utilizzando dosaggi su base individuale o controindicandone il loro uso in alcuni soggetti. Questo rappresenta la ragione dello studio ancillare di farmacogenetica.

    E.3Principal inclusion criteria
    - Aged between 6 months and 15 years. - A signed Consent Form collection from parents or legal guardian. - Proven diagnosis of Dravet`s syndrome *. - Treated with VPA and CLB at usual dosages (at the appreciation of the investigator). - Clonic or tonic-clonic seizures not adequately controlled with VPA and CLB at usual dosages (at the appreciation of the investigator). * Criteria for “confirmed diagnosis of Dravet syndrome” - First seizure before the age of 1 year - Seizure types: convulsive seizures (clonic or tonic-clonic) - generalized or hemibody seizures - usually prolonged ((> 15 minutes), - febrile and afebrile - Later on (from the age fo1year to 2 years) seizure types possible: myoclonia, absences, partial seizures - Normal psychomotor development before the first seizure - Later on, severe mental retardation - EEG usually normal before the first seizure - Later on, abnormalities usually present *Diagnostic criteria for Dravet’s syndrome in patients between 6 months and 1 year - At least two clonic or tonic-clonic seizures, either generalized or unilateral or followed by a unilateral deficit - At least one afebrile seizure - At least one prolonged seizure (> 15 minutes), - In case of unilateral seizures or seizures followed by a unilateral deficit, both sides having been involved at least once - Normal psychomotor development - No pathological perinatal antecedent
    - Eta` compresa tra i 6 mesi e i 15 anni. - Rilascio del consenso informato sottoscritto e datato e dei documenti di assenso in cui si indichi che il soggetto e i genitori del soggetto o il suo rappresentante legale siano stati informati di tutti gli aspetti rilevanti dello studio. - Diagnosi confermata di sindrome di Dravet.* - Soggetti trattati con VPA e CLB alle dosi usuali (secondo il giudizio dello sperimentatore). - Crisi cloniche o tonico-cloniche non controllate adeguatamente con VPA e CLB alle dosi usuali (secondo il giudizio dello sperimentatore). *Criteri che confermano la diagnosi di Sindrome di Dravet • Prima crisi precedente al 1° anno di eta` • Tipologie di crisi: convulsive (cloniche o tonico-cloniche) • generalizzate o unilaterali • spesso prolungate (si parlera` di convulsivo di male epilettico se la durata e` &gt; 15 minuti) • febbrili o afebbrili • piu` tardi (da 1 anno a 2 anni), possono presentarsi altre tipologie di crisi: • crisi miocloniche, assenze, crisi parziali • sviluppo psicomotorio normale prima della 1a crisi • successivamente e spesso grave ritardo mentale • EEG normale prima della 1a crisi • successivamente e spessoEEG anormale Criteri necessari per formulare la diagnosi di Sindrome di Dravet in soggetti di eta` compresa tra i 6 mesi ed 1 anno: • almeno 2 crisi, convulsive, cloniche o tonico-cloniche, o generalizzate o unilaterali o con deficit unilaterale • almeno una crisi afebbrile • almeno una crisi prolungata (≥15 minuti) • in caso di crisi unilaterali o crisi seguite da deficit unilaterale, almeno una volta devono essere interessati entrambi gli emicorpi • sviluppo psicomotorio normale • non precedenti patologie perinatali
    E.4Principal exclusion criteria
    - Patients currently treated or history of treatment [in the past] with STP or TPM, - Patients treated with any other AED than VPA and CLB within one month before screening visit, with the exception of diazepam [(VALIUM)], midazolam, lorazepam and clonazepam [(RIVOTRIL)] if used [only] occasionally as emergency treatment for epileptic seizures, - Patients treated with medications known as inhibitors of the CYP3A4 (macrolides, azol antifungal agents, theophylline) or with oral anti-coagulants, - Parents or legal guardian unable to follow the study protocol and or complete the subject’s seizures diary, - Contra indications to study treatments : o Hypersensitivity to the active substance or to any of the excipients. o History of psychoses in the form of episodes of delirium o Renal and/or hepatic function disorder o Glucose and galactose malabsorption o Congenital intolerance to fructose o patients with myasthenia gravis o severe respiratory insufficiency o sleep apnoea syndrome - ongoing pregnancy or breastfeeding female, - childbearing potential female not willing to use an effective mean of contraception, - parents or legual guardians unable to give their consent.
    - Incapacita` dei del genitori tutore a fornire il consenso. - Soggetti in trattamento o trattati in passato con STP o TPM. - Soggetti trattati con altri farmaci antiepilettici diversi da VPA e CLB nel mese precedente la visita di inclusione nello studio, con eccezione di diazepam (VALIUM) e clonazepam(RIVOTRIL), midazolam e lorazepam, se utilizzati solo occasionalmente come trattamento di emergenza nelle crisi epilettiche. - Soggetti trattati con farmaci riconosciuti come inibitori del CYP3A4 (macrolidi, antifungini azolici, teofillina) o con anticoagulanti orali. - Genitori o tutore legale incapaci di seguire il protocollo di studio e/o compilare il diario delle crisi - Gravidanza o allattamento in corso - Ragazze potenzialmente fertili non disposte ad utilizzare un mezzo di contraccezione efficace - Controindicazioni ai trattamenti dello studio:  Ipersensibilita` alla sostanza attiva o ad alcuni eccipienti  Storia di psicosi in forma di delirio  Disordini della funzionalita` renale o epatica  Male assorbimento del glucosio e galattosio  Intolleranza congenita al fruttosio  Miastenia grave  Insufficienza respiratoria grave  Sindrome da apnea notturna
    E.5 End points
    E.5.1Primary end point(s)
    Absolute variation of the monthly number of clonic or tonic-clonic seizures and status epilepticus (defined as clonic or tonic-clonic seizures > 15 minutes), formulated for 30 days in the double blind comparison period (total number of seizures over the three months divided by 3) compared to the screening period ( total number of seizures over the 5 weeks * 4/5).
    Variazione assoluta del numero mensile di crisi clonico o tonico-cloniche e dello stato epilettico, formulato per 30 giorni nel periodo di confronto in doppio cieco (numero totale di crisi su 3 mesi diviso per 3) comparato al periodo di screening (numero totale di crisi su 5 settimane *4/5)
    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 Yes
    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) 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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.8.4.1Number of sites anticipated in Member State concerned15
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA65
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    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 years0
    E.8.9.1In the Member State concerned months41
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months41
    E.8.9.2In all countries concerned by the trial days0
    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: 0
    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) Yes
    F.1.1.5Children (2-11years) Yes
    F.1.1.6Adolescents (12-17 years) Yes
    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 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
    soggetti minori
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 90
    F.4.2.2In the whole clinical trial 90
    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 Decision2007-07-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-07-03
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2011-06-30
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