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    Summary
    EudraCT Number:2009-016648-38
    Sponsor's Protocol Code Number:C10953/3074
    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:2012-03-07
    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 number2009-016648-38
    A.3Full title of the trial
    A 6-Month, Open-Label, Flexible-Dosage (150 to 200 mg/day) Extension Study of the Safety and Efficacy of Armodafinil Treatment as Adjunctive Therapy in Adults with Major Depression Associated with Bipolar I Disorder.
    Studio di estensione di 6 mesi a dosaggio flessibile (da 150 a 200 mg/die), in aperto per la valutazione della sicurezza e dell'efficacia del trattamento con Armodafinil come terapia aggiuntiva negli 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 for 6 months with mood stabilizers in subjects with major depression associated with bipolar I disorder.
    Lo scopo di questo studio e' di osservare la sicurezza, l'efficacia e la tollerabilita' di armodafinil quando e' usato per 6 mesi con gli stabilizzatori dell'umore in soggetti con depressione maggiore associata a disturbi bipolare I.
    A.4.1Sponsor's protocol code numberC10953/3074
    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 supportCephalon Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIngenix International 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 No
    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 nameArmodafinil
    D.3.2Product code CEP-10953
    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 INNMODAFINIL
    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
    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 I Disorder.
    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 periodic alteration of mood (maniacal episodes alternated with depressive episodes).
    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 this study is to evaluate the safety and tolerability of long-term (6 months) armodafinil treatment as adjunctive therapy to mood-stabilizing medications in adults with bipolar I disorder whose most recent episode was a depressive episode.
    L'obiettivo primario dello studio è determinare la sicurezza e la tollerabilità di un periodo di trattamento a lungo termine (6 mesi) con armodafinil aggiunto alla terapia di stabilizzatori dell'umore in adulti con disturbo bipolare di tipo I che hanno manifestato un recente episodio depressivo.
    E.2.2Secondary objectives of the trial
    ° To evaluate long-term efficacy of armodafinil 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) for depression to week 1 and months 1, 2, 4 and 6 (or last postbaseline observation) ° To evaluate the efficacy of armodafinil treatment on patients functioning as assessed by the Global Assessment of Functioning (GAF) Scale scores at month 6 (or last postbaseline observation).
    ° Valutare l'efficacia di un trattamento a lungo termine con Armodafinil come terapia aggiuntiva in adulti che hanno manifestato un episodio di depressione maggiore associato al disturbo bipolare I. ° Valutare la variazione dal basale della Impressione globale clinica della gravità (CGI-S)della depressione alla settimana 1 e ai mesi 1, 2, 4 e 6 (o all'ultima osservazione postbasale). °Valutare la efficacia del trattamento con armodafinil sul funzionamento del paziente valutata con la Scala di Valutazione Globale di Funzionamento (GAF) al mese 6 (o all'ultima osservazione postbasale).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients are included in the study if all the following criteria are met: (a)The patient has completed 8 weeks of treatment in a Cephalon-sponsored Phase 3, double-blind study of armodafinil treatment in patients with major depression associated with bipolar I disorder. (b)The patient met criteria for enrollment in the previous double-blind study and, in the opinion of the investigator, is in need of continued treatment for depression. (C)During the previous double-blind study, the patient must have been taking 1 (or 2) of the following protocol-allowed mood stabilizers: lithium; valproic acid; aripiprazole; olanzapine; ziprasidone taken in combination with lithium or valproic acid; lamotrigine; or risperidone. (d) The patient has a YMRS totals score of 14 or less at the enrollment visit. Patients who have a YMRS score of 12 through 14 must be discussed with the medical monitor to determine their suitability for enrollment.(e) The patientis a man or woman 18 through 65 years of age at the time of enrollment in the double-blind study. (f)The patient is in good health (except for diagnosis of bipolar I disorder)as judged by the investigator, on the basis of medical and psychiatric history, medical examination, ECG, serum chemistry, hematology, and urinalysis results.(g)Women of childbearing potential who are sexually active must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for 30 days after participation in the study.(h)The patient is willing and able to comply with restrictions and to attend regularly scheduled clinic visits as specified in this protocol.(i)The patient has permanent accommodations and means of being contacted by the study center.(j)The patient agrees not to enroll in any other clinical study while participating in this study.(k)The patient may temporarily reside in a clinic or hospital, or may currently be treated in an over-night medical facility at the beginning of and throught the study, in a manner consistent with medical practices as related to the treatment of depression associated with bipolar I disorder.
    I pazienti vengono inclusi nello studio se tutti i seguenti criteri sono soddisfatti: (a)Il paziente ha completato 8 settimane di trattamento in uno studio in doppio cieco di Fase 3 sponsorizzato da Cephalon per la valutazione del trattamento con armodafinil nei pazienti affetti da depressione grave associata a disturbo bipolare I.(b) Il paziente soddisfa i criteri di arruolamento dello studio in doppio cieco precedente e, a giudizio dello sperimentatore, necessita di proseguire il trattamento per la depressione.(c) Nel corso dello studio in doppio cieco precedente il paziente deve avere assunto 1 (o 2) dei seguenti stabilizzatori dell'umore consentiti dal protocollo: litio, acido valproico, aripiprazolo, olanzapina, ziprasidone in combinazione con litio o acido valproico, lamotrigina o risperidone (d) Alla visita di arruolamento il paziente ha un punteggio YMRS totale pari o inferiore a 14. I pazienti con un punteggio YMRS compreso tra 12 e 14 devono essere discussi con il supervisore medico per determinarne l'idoneità all'arruolamento.(e) Il paziente è un maschio o una femmina di età compresa tra 18 e 65 anni al momento dell'arruolamento nello studio in doppio cieco. (f) Il paziente è in buono stato di salute (a eccezione della diagnosi di disturbo bipolare I) a giudizio dello sperimentatore e sulla base dell'anamnesi medica e psichiatrica, dell'esame fisico, dell'ECG, della chimica sierica, dell'ematologia e dell'analisi delle urine.(g) Le donne in età fertile (donne che non hanno raggiunto la menopausa, donne in stato post-menopausale da meno di 2 anni e donne che non sono chirurgicamente sterili) che siano sessualmente attive devono adottare un metodo contraccettivo medicalmente accettato e accettare di proseguirne l'uso per l'intera durata dello studio e per i 30 giorni successivi alla fine della partecipazione allo studio. (h) Il paziente è disposto e in grado di osservare le restrizioni dello studio e di presentarsi regolarmente alle visite cliniche programmate come da protocollo. (i) Il paziente ha domicilio permanente e può essere contattato dal centro dello studio. (j) Il paziente accetta di non arruolarsi in alcun altro studio clinico per la durata della sua partecipazione al presente studio. (k) Il paziente può risiedere temporaneamente in una clinica o ospedale, o essere al momento in cura presso una struttura medica con permanenza notturna, all'inizio e durante lo svolgimento dello studio, conformemente alle pratiche mediche relative al trattamento della depressione associata a disturbo bipolare I.
    E.4Principal exclusion criteria
    Patients are excluded from particiapting in this study if 1 or more of the following criteria are met.(a)The patient has any Axis I or Axix II disorder apart from bipolar I disorder that became the primary focus of treatment during the double-blind study.(b)The patient has psychotic symptoms or had psychosis during the double-blind study.(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 enrollment has score of 2 or more for item 18 on the IDS-C30. (d) The patient met criteria for alcohol or substance abuse or dependence (with the exception of nicotine dependence) during the double-blind study. (e)The patient has any history of homicidal ideation or significant aggression or currently has homicidal or significant aggressive ideation.(f)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.(g)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 brain surgery.(h)The patient has left ventricular hypertrophy or the patient has mitral valve prolapse and has experienced mitral valve prolapse syndrome.(i)The patient has human immunodeficieny virus (HIV).(j)The patient has any clinically significant uncontrolled medical condition, treated or untreated.(k)In the judgment of the investigator, the patient has any clinically significant deviation from normal in the physical examination.(l)The patient has evidence of current non-medical substance use on urine drug screen (UDS) or by history.(m)The patient is a pregnant or lactating woman (Any woman becoming pregnant during the study will be withdrawan from the study)(n)The patient has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion (ADME)(including gastrointestinal surgery).(o)The patient is unlikely to comply with the study protocol or is unsuitable for any other reason, as judged by the investigator or medical monitor.(p)The patient is an inpatient without consent or is institutionalized for reasons other than the conditions stipulated in inclusion criterion a.
    I pazienti sono esclusi dalla partecipazione a questo studio se soddisfano uno o più dei seguenti criteri.(a)Il paziente presenta un disturbo dell'Asse I o dell'Asse II diverso dal disturbo bipolare I che è diventato l'interesse primario del trattamento durante lo studio in doppio cieco.(b)Il paziente ha sintomi psicotici o ha presentato psicosi durante lo studio in doppio cieco. (c)Il paziente ha idee suicide correnti, è a rischio imminente di autolesionismo o ha una storia significativa di idea o tentativo di suicidio in qualsiasi momento nel passato e che causa preoccupazioni al momento; oppure al momento dell'arruolamento il paziente presenta un punteggio pari o superiore a 2 per la voce 18 dell'inventario IDS-C30. (d)Il paziente soddisfaceva i criteri di abuso o dipendenza da sostanze o alcool (a eccezione della dipendenza da nicotina) durante lo studio in doppio cieco.(e)Il paziente ha un'anamnesi di idee omicide o aggressività significativa, oppure al momento ha idee omicide o significativamente aggressive.(f)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.(g)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.(h)Il paziente soffre di ipertrofia ventricolare sinistra o prolasso mitralico valvolare e ha manifestato la sindrome da prolasso mitralico valvolare. (i)Il paziente è affetto dal virus dell'immunodeficienza umana (HIV). (j)Il paziente ha una condizione patologica non controllata clinicamente significativa, in trattamento o meno.(k)Secondo l'opinione dello sperimentatore, il paziente ha una qualsiasi deviazione clinicamente significativa dai parametri normali rilevata nell'esame obiettivo.(l)Il paziente presenta evidenza di uso corrente o anamnesi di sostanze non mediche nella ricerca di farmaci/droghe nelle urine (UDS). (m)La paziente è una donna incinta o che allatta. (Le donne che rimangono incinta nel corso dello studio saranno ritirate dallo studio).(n)Il paziente presenta un qualsiasi disturbo che potrebbe interferire con l'assorbimento, la distribuzione, il metabolismo o l'escrezione (ADME) del farmaco, inclusi interventi di chirurgia gastrointestinale. (o)Il paziente che verosimilmente non sarà in grado di conformarsi al protocollo dello studio, oppure il paziente non è idoneo per qualsiasi altra ragione, in base al giudizio dello sperimentatore o del supervisore medico.(p) Il paziente è stato ricoverato senza il suo consenso oppure è stato istituzionalizzato per motivi diversi dalle condizioni indicate nel criterio di inclusione a.
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy endpoints for this study are as follows: °THe IDS-C30 °The QIDS-C16 °The CGI-S for depression °The GAF Scale
    Gli endpoint primari di efficaciadi questo studio sono i seguenti: °Punteggio IDS-C30 °Punteggio QIDS-C16 °Punteggio CGI-S per la depressione °Scala GAF
    E.5.1.1Timepoint(s) of evaluation of this end point
    ° The IDS-C30 assessed at week 1 and months 1,2,4 and 6 (or last postbaseline observation). °The QIDS-C16 (Which will be derived from the IDS-C30) assessed at week 1 and months 1,2,4 and 6 (or last postbaseline observation) °The CGI-S for depression assessed at week 1 and months 1,2,4 and 6 (or last postbaseline observation) °The GAF Scale assessed at month 6 (or last postbaseline observation).
    • Punteggio IDS-C30 calcolato alla settimana 1 e ai mesi 1, 2, 4 e 6 (o all'ultima osservazione postbasale). • Punteggio QIDS-C16 (che sarà derivato dal punteggio IDS-C30) calcolato alla settimana 1 e ai mesi 1, 2, 4 e 6 (o all'ultima osservazione dopo la baseline) • Punteggio CGI-S calcolato alla settimana 1 e ai mesi 1, 2, 4 e 6 (o all'ultima osservazione dopo la baseline) • Scala GAF valutata al mese 6 (o all'ultima osservazione dopo la baseline)
    E.5.2Secondary end point(s)
    Safety endpoints are as follows: °clinical laboratory test (serum chemistry, hematology and urinalysis) °vital signs (blood pressure and pulse) °ECGs °Physical examinations °body weight °concomitant medication usage °YMRS °C-SSRS-SLV °ISI °HAM-A
    Gli endpoint secondari di sicurezza sono i seguenti: •valutazione delle analisi cliniche di laboratorio (chimica serica, ematologia e analisi delle urine) • valutazione dei segnali vitali (pressione arteriosa e polso) • valutazione dell'ECG • valutazione dell'esame fisico • valutazione del peso corporeo • uso di farmaci concomitanti durante lo svolgimento dello studio • valutazione del punteggio YMRS • valutazione della scala C-SSRS-SLV • valutazione dell'indice ISI • valutazione del punteggio HAM-A
    E.5.2.1Timepoint(s) of evaluation of this end point
    ° clinical laboratory tests(serum chemistry, hematology and urinalysis) assessed at month 6 (or last postbaseline observation). ° vital signs (blood pressure and pulse) at week 1 and months 1,2 4 and 6 (or last postbaseline observation) °ECGs at month 6 (or last postbaseline observation) °physical examinations at month 6 (or last postbaseline observation) °body weight at month 6 (or last postbaseline observation) °concomitant medication usage throughtout study °YMRS at week 1 and months 1,2,4 and 6 (or last postbaseline observation) °C-SSRS-SLV at week 1 and months 1,2,4 and 6 (or last postbaseline observation) °ISI at week 1 and months 1, 2, 4 and 6 (or last postbaseline observation) °HAM-A at month 6 (or last postbaseline observation).
    • analisi cliniche di laboratorio al mese 6 (o all'ultima osservazione dopo il basale) • segni vitali alla settimana 1 e ai mesi 1, 2, 4 e 6 (o all'ultima osservazione dopo il basale) •ECG al mese 6 (o all'ultima osservazione dopo il basale) •esame fisico al mese 6 (o all'ultima osservazione dopo il basale) •peso corporeo al mese 6 (o all'ultima osservazione dopo il basale) •uso di farmaci concomitanti durante lo svolgimento dello studio •YMRS alla settimana 1 e ai mesi 1, 2, 4 e 6 (o all'ultima osservazione dopo il basale) • C-SSRS-SLV alla alla settimana 1 e ai mesi 1, 2, 4 e 6(o all'ultima osservazione dopo il basale) •ISI alla settimana 1 e ai mesi 1, 2, 4 e 6 (o all'ultima osservazione dopo il basale).•HAM-A al mese 6 (o all'ultima osservazione dopo il 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 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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial1
    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 concerned8
    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 months24
    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 months24
    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)
    Standard Care.
    Terapie 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 Decision2011-11-29
    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 StatusPrematurely Ended
    P.Date of the global end of the trial2013-09-03
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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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