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    Summary
    EudraCT Number:2010-023623-26
    Sponsor's Protocol Code Number:C10953/3073
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-02-27
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2010-023623-26
    A.3Full title of the trial
    A Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dosage Study to Evaluate the Efficacy and Safety of Armodafinil Treatment (150 mg/day) as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder
    Studio in doppio cieco, controllato con placebo, a gruppi paralleli e a dose fissa, mirato a valutare l' ™efficacia e la sicurezza del trattamento con Armodafinil (150 mg/die), come terapia addizionale in adulti affetti da depressione maggiore associata a disturbo bipolare I
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The purpose of this study is to look at the safety, effectiveness, and tolerability of armodafinil when used with mood stabilizers in subjects with major depression associated with bipolar I disorder.
    Lo scopo di questo studio e' valutare la sicurezza, efficacia e la tollerabilita' di armodafinil quando e' utilizzato come stabilizzatore dell'umore in soggetti con Depressione maggiore associata a disturbo Bipolare di Tipo I
    A.4.1Sponsor's protocol code numberC10953/3073
    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 SponsorCEPHALON FRANCE
    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 supportCepaholn Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIngenix Internation Italy (Srl)
    B.5.2Functional name of contact pointStart Up Group Global Regulatory
    B.5.3 Address:
    B.5.3.1Street AddressVia Cristoforo Colombo, 163
    B.5.3.2Town/ cityRoma
    B.5.3.3Post code00147
    B.5.3.4CountryItaly
    B.5.4Telephone number+39 0544 213422
    B.5.5Fax number+39 0544 246266
    B.5.6E-mailpaolo.collia@i3research.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 Armodafinil
    D.2.1.1.2Name of the Marketing Authorisation holderCephalon Inc.
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 INNNA
    D.3.9.1CAS number 112111-43-0
    D.3.9.2Current sponsor codeCEP-10953
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeNA
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    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
    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
    Major Depression associated with Bipolar Disorder I.
    Depressione Maggiore associata con il Disturbo Bipolare I.
    E.1.1.1Medical condition in easily understood language
    Serious depression associated with psychic disorder characterized by cyclic change of mood (manic period followed be depressive period)
    Depressione grave associata al disturbo psichico caratterizzato da alterazioni cicliche dell'umore (episodi maniacali alternati a episodi depressivi).
    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 10004911
    E.1.2Term Bipolar affective disorder, depressed
    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 the study is to determine whether armodafinil treatment, at a dosage of 150 mg/day, is more effective than placebo treatment as adjunctive therapy to mood stabilizers for treatment of adults with major depression associated with bipolar I disorder. Efficacy will be assessed by the mean change from baseline in the total score from the 30 Item Inventory of Depressive Symptomatology–Clinician Rated (IDS C30).
    L’obiettivo primario dello studio è determinare se il trattamento con armodafinil, a una dose di 150 mg/die, sia più efficace del trattamento con placebo come terapia addizionale agli stabilizzatori dell’umore, per il trattamento di pazienti adulti affetti da depressione maggiore associata a disturbo bipolare I.L’efficacia sarà valutata tramite la variazione media dal basale del punteggio totale ricavato dall’Inventario della sintomatologia depressiva da 30 voci, di eterovalutazione (IDS-C30).
    E.2.2Secondary objectives of the trial
    • To evaluate the efficacy of armodafinil treatment compared with placebo treatment as adjunctive therapy for adults who are experiencing a major depressive episode associated with bipolar I disorder, • To evaluate the change from baseline in the Clinical Global Impression of Severity (CGI-S) of illness rating for depression • to evaluate the efficacy of armodafinil treatment compared with placebo treatment on patient functioning as assessed by the Global Assessment of Functioning (GAF) Scale scores • To evaluate the safety and tolerability of armodafinil treatment
    • Valutare l’efficacia del trattamento con armodafinil rispetto al placebo come terapia addizionale in adulti che stanno manifestando un episodio depressivo maggiore associato a disturbo bipolare I • Valutare la variazione dal basale nell’Impressione globale clinica della gravità (CGI-S) della valutazione della malattia per la depressione • Valutare l’efficacia del trattamento con armodafinil rispetto al placebo sulla funzionalità del paziente, valutata tramite i punteggi della scala di Valutazione globale del funzionamento (GAF) • Valutare la sicurezza e la tollerabilità del trattamento con armodafinil
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    (a)The patient has a diagnosis of bipolar I disorder according to the Diagnostic and Statistical Manual of Mental Disorders (DSM IV-TR) criteria (b) The investigator has established, by medical record documentation or by history from the patient and at least 1 reliable informant, that the patient has had at least 1 previous manic or mixed episode, which resulted in functional impairment and was treated (or should have been treated) with a mood stabilizer or antipsychotic medication. (c) The patient has had no more than 6 mood episodes in the last year. (d) The patient’s current major depressive episode must have started no less than 2 weeks and no more than 12 months prior to the screening visit. The current depressive episode must have begun after the patient’s current mood stabilizer regime began. Date of onset of the current depressive episode must be at least 8 weeks after resolution of any previous mood episode (ie, depressive, manic, hypomanic, or mixed episode). (e) The patient must have been taking 1 (or 2) of the following protocol allowed mood stabilizers: • lithium • valproic acid • lamotrigine • aripiprazole • olanzapine • risperidone • ziprasidone (only if taken in combination with lithium or valproic acid) The following criteria must also be met: • The mood stabilizer(s) must have been taken a minimum 4 weeks before the onset of the major depressive episode and still be taken at the time of the screening visit at dose or blood level considered appropriate for maintenance therapy by the patient’s physician. • The patient must continue to take the same mood stabilizer(s) during the screening period; no mood stabilizer may be added during the screening period. • The mood stabilizer(s) must be taken for a minimum of 8 weeks prior to the baseline visit. • The dosage of the mood stabilizer(s) must be stable for a minimum of 4 weeks prior to the baseline visit. Minimum required dosages and plasma concentrations, if applicable, and the lengths of time for these minimum requirements (4 or 8 weeks depending on the medication) are provided in the protocol. • The mood stabilizer(s) must be taken in an oral formulation, with the exception of risperidone, which can be either in an oral or long acting injection formulation. • The patient may be taking 2 protocol allowed mood stabilizers only if 1 of the drugs is lithium or valproic acid. (f) The patient has been on a stable dosage of all other permitted medications (with the exception of medication to be used on an as needed basis) for 2 weeks prior to the baseline visit. (g) The patient has a score of 13 or more on the QIDS-C16 at the screening and baseline visits. (NOTE: The QIDS C16 will be derived from specified items in the IDS C30.) (h) The patient has a CGI-S rating (for depression) of 4 (moderately ill) or higher at the screening visit and at the baseline visit. (i) The patient has a YMRS total score of 10 or less at the screening and baseline visits. (j) The patient has a YMRS score of 0 or 1 on items 1 through 3 at the screening and baseline visits. (k) Written informed consent is obtained. (l) The patient is a man or woman 18 through 65 years of age.
    (a) Il paziente ha una diagnosi di disturbo bipolare I secondo i criteri del Manuale Diagnostico e Statistico delle Malattie Mentali(DSM-IV-TR) (b) Lo sperimentatore ha stabilito, tramite documentazione di cartelle cliniche o anamnesi del paziente e almeno da un informatore attendibile, che il paziente ha manifestato almeno 1 precedente episodio maniacale o misto, il quale ha causato disabilità funzionale ed è stato trattato (o avrebbe dovuto essere trattato) con uno stabilizzatore dell’umore o farmaco antipsicotico (c) Il paziente non ha avuto più di 6 episodi di alterazione dell’umore nell’ultimo anno. (d) L’attuale episodio depressivo maggiore del paziente deve essersi manifestato non meno di 2 settimane e non più di 12 mesi prima della visita di screening. L’episodio depressivo attuale deve essere iniziato dopo che il paziente ha iniziato il regime attuale di stabilizzazione dell’umore. La data di inizio dell’attuale episodio depressivo deve essere posteriore di almeno 8 settimane alla risoluzione di un eventuale episodio precedente di alterazione dell’umore (cioè, episodio depressivo, maniacale, ipomaniacale o misto). (e) Il paziente deve aver assunto uno (o due) dei seguenti stabilizzatori dell’umore permessi dal protocollo: • litio • acido valproico • lamotrigina • aripiprazolo • olanzapina • risperidone • ziprasidone (solo se assunto in combinazione con litio o acido valproico) Devono essere rispettati inoltre i seguenti criteri: • Lo stabilizzatore o gli stabilizzatori dell’umore devono essere stati assunti da almeno 4 settimane prima dell’insorgenza dell’episodio depressivo maggiore e devono essere ancora assunti al momento della visita di screening alla dose o livello ematico ritenuto opportuno per la terapia di mantenimento, secondo il parere del medico del paziente. • Il paziente deve continuare ad assumere lo stesso o stessi stabilizzatore/i dell’umore durante il periodo di screening: non è consentito aggiungere uno stabilizzatore dell’umore durante il periodo di screening. • Lo stabilizzatore o stabilizzatori dell’umore devono essere assunti per almeno 8 settimane prima della visita basale. • Il dosaggio dello stabilizzatore o degli stabilizzatori dell’umore deve essere stabile per almeno 4 settimane prima della visita basale. I requisiti di dosaggio minimo e delle concentrazioni nel plasma, se pertinenti, e la durata per questi requisiti minimi (4 o 8 settimane a seconda del farmaco) sono evidenziati nel protocollo. • Lo stabilizzatore o gli stabilizzatori dell’umore devono essere assunti in formulazione orale, con l’eccezione del risperidone, che può essere in forma orale o per iniezione a lunga durata. • Il paziente può assumere 2 stabilizzatori dell’umore consentiti dal protocollo soltanto se uno dei farmaci è il litio o l’acido valproico. (f) Il paziente è stato trattato con dosaggio stabile di tutti gli altri farmaci permessi (con l’eccezione di farmaci da usare secondo necessità) per 2 settimane prima della visita basale. (g) Il paziente ha un punteggio pari o superiore a 13 nel QIDS-C16 alle visite di screening e basale (NOTA: il QIDS-C16 deriverà da elementi specificati nell’IDS-C30). (h) Il paziente ha un punteggio CGI-S (per la depressione) pari o superiore a 4 (moderatamente malato) alla visita di screening e alla visita basale. (i) Il paziente ha un punteggio totale YMRS pari o inferiore a 10 alle visite di screening e basale. (j) Il paziente ha un punteggio YMRS pari a 0 o 1 nei punti da 1 a 3 alle visite di screening e basale. (k) Si è ottenuto il consenso informato scritto. (l) Il paziente è un uomo o una donna di età compresa tra i 18 e i 65 anni.
    E.4Principal exclusion criteria
    (a)The patient has any Axis I disorder apart from bipolar I disorder that was the primary focus of treatment within 6 months of the screening visit or during the screening period. (b)The patient has psychotic symptoms or has had psychosis within 4 weeks of the screening visit or during the screening period. (c) The patient has current active suicidal ideation, is at imminent risk of self harm, or has a history of significant suicidal ideation or suicide attempt at any time in the past that causes concern at present; or, at any time during the screening period or at baseline has a score of 2 or more for item 18 on the IDS C30. (d) The patient has any history of homicidal ideation or significant aggression or currently has homicidal or significant aggressive ideation. (e) The patient has a history of an eating disorder or obsessive compulsive disorder (OCD) within 6 months of the screening visit or during the screening period. (f) The patient has a history of alcohol or substance abuse or dependence (with the exception of nicotine dependence) within 3 months of the screening visit or during the screening period. (g) The patient has borderline personality disorder or antisocial personality disorder. (h) The patient has any other Axis II disorder that could interfere with the conduct of the study. (i) The patient has a HAM A score of 17 or more at the baseline visit. (j) The patient has a history of any cutaneous drug reaction or drug hypersensitivity reaction, a history of any clinically significant hypersensitivity reaction, or a history of multiple clinically relevant allergies. (k) The patient has a past or present seizure disorder (except history of a single febrile seizure), or a history of clinically significant head trauma (eg, brain damage) or of brain surgery. (l) The patient has left ventricular hypertrophy or the patient has mitral valve prolapse and has experienced mitral valve prolapse syndrome. (m) The patient has human immunodeficiency virus (HIV). (n) The patient has any clinically significant uncontrolled medical condition, treated or untreated. (o) In the judgment of the investigator, the patient has any clinically significant deviation from normal in the physical examination. (p) The patient has 1 or more clinical laboratory test values outside the ranges specified in the protocol (q) The patient has any other clinically significant laboratory abnormality, without prior written approval by the medical monitor. (r) The patient has a positive urine drug screen (UDS) for anything other than cannabis.
    (a) Il paziente soffre di un altro disturbo dell’Asse I, oltre al disturbo bipolare I che è il motivo principale per il trattamento, entro 6 mesi dalla visita di screening o durante il periodo di screening. (b) Il paziente ha sintomi psicotici o ha avuto psicosi entro 4 settimane dalla visita di screening o durante il periodo di screening. (c) Il paziente ha attuali idee suicide attive, è a rischio imminente di autolesione, o ha un’anamnesi di idee suicide significative o di tentativi di suicidio in qualsiasi momento del passato che destano preoccupazione attualmente; oppure, in qualsiasi momento durante il periodo di screening o al basale, il paziente ottiene un punteggio di 2 o superiore per l’elemento 18 su IDS-C30. (d) Il paziente ha un’anamnesi di idee omicide o aggressività significativa, oppure al momento ha idee omicide o significativamente aggressive. (e) Il paziente ha un’anamnesi di disturbi alimentari o disturbo ossessivo-compulsivo (OCD) entro 6 mesi dalla visita di screening o durante il periodo di screening. (f) Il paziente ha un’anamnesi di alcolismo o di abuso di sostanze stupefacenti o dipendenza (ad eccezione della dipendenza da nicotina) entro 3 mesi dalla visita di screening o durante il periodo di screening. (g) Il paziente è affetto da disturbo borderline della personalità o disturbo antisociale della personalità. (h) Il paziente ha qualsiasi altro disturbo dell’Asse II che potrebbe interferire con la conduzione dello studio. (i) Il paziente ha un punteggio HAM-A di 17 o maggiore alla visita basale. (j) Il paziente ha un’anamnesi di reazione cutanea ai farmaci o reazione di ipersensibilità ai farmaci, un’anamnesi di reazione di ipersensibilità clinicamente significativa o un’anamnesi di allergie multiple clinicamente rilevanti. (k) Il paziente ha, o ha avuto, un disturbo epilettico (escluso il caso di una singola convulsione febbrile) o un’anamnesi di trauma cranico clinicamente significativo (ad es., danno cerebrale) o di intervento chirurgico al cervello. (l) Il paziente soffre di ipertrofia ventricolare sinistra o prolasso valvolare mitralico e ha manifestato la sindrome da prolasso valvolare mitralico. (m) Il paziente è affetto dal virus dell’immunodeficienza umana (HIV). (n) Il paziente ha una condizione patologica non controllata clinicamente significativa, in trattamento o meno. (o) Secondo l’opinione dello sperimentatore, il paziente ha una qualsiasi deviazione clinicamente significativa dai parametri normali rilevata nell’esame obiettivo. (p) Il paziente presenta 1 o più valori degli esami di laboratorio al di fuori dell’intervallo indicato nel protocollo (q) Il paziente presenta una qualsiasi altra anormalità dei test di laboratorio clinicamente significativa, senza previa approvazione scritta da parte del supervisore medico (medical monitor). (r) Il paziente mostra un valore positivo nell’esame delle urine per sostanze stupefacenti (UDS) per altra sostanza che non sia cannabis.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy measure and endpoint for this study is the IDS C30 assessed at all postbaseline visits.
    La misura e l’endpoint di efficacia primaria per questo studio è l’IDS-C30 valutato a tutte le visite post-basali
    E.5.1.1Timepoint(s) of evaluation of this end point
    All postbaseline visits
    A tutte le visite post-basali.
    E.5.2Secondary end point(s)
    • IDS C30
    • CGI-S for depression
    • GAF Scale
    • IDS-C30
    • CGI-S per la depressione
    • Scala GAF
    E.5.2.1Timepoint(s) of evaluation of this end point
    • the IDS C30 will be assessed at weeks 1, 2, 4, 6, 7, and 8, or last postbaseline observation
    • CGI-S for depression will be assessed at weeks 1, 2, 4, 6, 7, and 8, or last postbaseline observation
    • GAF Scale will be assessed at weeks 4 and 8, or last postbaseline observation
    • l’IDS-C30 verrà valutata alle settimane 1, 2, 4, 6, 7 e 8 o all’ultima osservazione post-basale
    • CGI-S per la depressione verrà valutata alle settimane 1, 2, 4, 6, 7 e 8 o all’ultima osservazione post-basale
    • Scala GAF verrà valutata alle settimane 4 e 8 o all’ultima osservazione post-basale
    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) 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 trial2
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    European Union
    Brazil
    Croatia
    India
    South Africa
    United States
    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
    LVLS
    LVLS
    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 months18
    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 months18
    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 No
    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) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 370
    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 No
    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 220
    F.4.2.2In the whole clinical trial 370
    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)
    Patients who complete the double-blind treatment period may be eligible to enroll in an open-label extension study (eg. study C10953/3074).
    Patients who do not complete the double-blind treatment period are ineligible for inclusion or decline to participate in the extension study will be treated as per normal standard care.
    I pazienti che completano il periodo di trattamento in doppio-cieco possono essere idonei per essere arruolati nello studio in estensione in aperto (p.e. studio C10953/3074). I pazienti che non completano il periodo di trattamento in doppio cieco e che non sono idonei per l'inclusione o che rifiutano di partecipare allo studio in estensione saranno trattati con le terapie normali standard.
    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 Decision2011-09-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-06-24
    P. End of Trial
    P.End of Trial StatusCompleted
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    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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