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    Summary
    EudraCT Number:2011-005177-23
    Sponsor's Protocol Code Number:N01395
    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:2012-06-14
    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 number2011-005177-23
    A.3Full title of the trial
    An open-label, multicenter, single-arm study to evaluate the reduction in nonpsychotic behavioral side effects in subjects with epilepsy switching from levetiracetam to brivaracetam due to nonpsychotic behavioral side effects
    Studio multicentrico, in aperto, a singolo braccio di trattamento per valutare la riduzione degli effetti collaterali comportamentali non psicotici in soggetti con epilessia che passano da Levetiracetam a Brivaracetam a causa di effetti collaterali comportamentali non psicotici
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Open-label trial to evaluate the reduction in nonpsychotic behavioral side effects in patients who switched to brivaracetam treatment after
    discontinuing levetiracetam due to nonpsychotic behavioral side effects.
    Studio in aperto per valutare la riduzione degli effetti collaterali comportamentali non psicotici in soggetti che passano al trattamento con Brivaracetam dopo aver interrotto levetiracetam a causa di effetti collaterali comportamentali non psicotici
    A.4.1Sponsor's protocol code numberN01395
    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 SponsorUCB PHARMA SA/NV.
    B.1.3.4CountryBelgium
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportUCB PHARMA SA/NV.
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUCB BIOSCIENCES GmbH
    B.5.2Functional name of contact pointClin Trial Reg & Results disclosure
    B.5.3 Address:
    B.5.3.1Street AddressAlfred-Nobel-Strasse 10
    B.5.3.2Town/ cityMonheim
    B.5.3.3Post code40789
    B.5.3.4CountryGermany
    B.5.4Telephone number+49 2173 48 1515
    B.5.5Fax number+49 2173 48 1573
    B.5.6E-mailclinicaltrials@ucb.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 nameBrivaracetam
    D.3.2Product code NA
    D.3.4Pharmaceutical form Film-coated 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 INNBRIVARACETAM
    D.3.9.1CAS number 357336-20-0
    D.3.9.2Current sponsor codeucb 34714
    D.3.9.3Other descriptive name(2S)-2-[(4R)-2-oxo-4-propyltetrahydro-1H-pyrrol-1-yl]butanamide
    D.3.9.4EV Substance CodeSUB25397
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation 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 nameBrivaracetam
    D.3.2Product code NA
    D.3.4Pharmaceutical form Film-coated 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 INNBRIVARACETAM
    D.3.9.1CAS number 357336-20-0
    D.3.9.2Current sponsor codeucb 34714
    D.3.9.3Other descriptive name(2S)-2-[(4R)-2-oxo-4-propyltetrahydro-1H-pyrrol-1-yl]butanamide
    D.3.9.4EV Substance CodeSUB25397
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    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 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
    Nonpyschotic Behavioural Side Effects in Subjects With Epilepsy
    Effetti collaterali comportamentali non psicotici in soggetti effetti da epilessia
    E.1.1.1Medical condition in easily understood language
    Epilepsy
    Epilessia
    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 10015037
    E.1.2Term Epilepsy
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the reduction of nonpsychotic behavioral side effects in subjects with epilepsy who switched to brivaracetam (BRV) 200mg/day after discontinuing levetiracetam (LEV) 1g/day to 3g/day due to these nonpsychotic behavioral side effects
    Valutare la riduzione degli effetti collaterali comportamentali non psicotici in soggetti con epilessia che passano a Brivaracetam (BRV) 200 mg/die dopo l’interruzione di Levetiracetam (LEV) da 1 g/die a 3 g/die a causa di questi effetti collaterali comportamentali non psicotici
    E.2.2Secondary objectives of the trial
    - To evaluate the reduction in intensity of nonpsychotic behavioral side effects in subjects with epilepsy who switched to BRV 200mg/day after discontinuing LEV use due to these nonpsychotic behavioral side effects
    - To evaluate the efficacy of BRV compared to a retrospective Baseline
    - To assess the overall safety and tolerability of BRV 200mg/day as adjunctive treatment in adult subjects with epilepsy after they have switched from LEV to BRV treatment
    - Valutare la riduzione di intensità degli effetti collaterali comportamentali non psicotici in soggetti con epilessia che passano a BRV 200 mg/die dopo l’interruzione dell’uso di LEV a causa di questi effetti collaterali comportamentali non psicotici
    - Valutare l’efficacia di BRV rispetto a un basale retrospettivo
    - Valutare la sicurezza e la tollerabilità generali di BRV 200 mg/die come trattamento aggiuntivo in soggetti adulti con epilessia dopo il passaggio dal trattamento con LEV al trattamento con BRV
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Subject is male or female and 16 years or older. Subjects under 18 years of age may be included only where legally permitted and ethically accepted.
    - Subject has a family member/caregiver or close contact person who is knowledgeable on a daily basis regarding the subject’s side effects. This family member/caregiver or close contact person should accompany the subject to the study visits or be available for discussion by telephone.
    - Subject with well-characterized epilepsy according to the 1989 ILAE classification
    - Subject with epilepsy who the Investigator expects would have benefitted from LEV but for whom the Investigator has decided to discontinue LEV due to nonpsychotic behavioral side effects following the introduction of LEV.
    - Subject is currently receiving LEV at a dose between 1g/day and 3g/day and currently treated with 2 to 3 AEDs, including LEV.
    - Permitted concomitant AED(s) (with the exception of LEV) and VNS are stable and at optimal dosage for the subject from at least 4 weeks (12 weeks for phenobarbital, phenytoin, and primidone) before V1 and are expected to be kept stable during the Screening and Treatment Periods.
    - Subject with a body weight ≥40kg.
    - Female subjects without childbearing potential (postmenopausal for at least 2 years, bilateral oophorectomy or tubal ligation, complete hysterectomy) are eligible. Female subjects with childbearing potential are eligible if they use a medically accepted contraceptive method
    - Soggetto maschio o femmina di età pari o superiore a 16 anni. I soggetti di età inferiore ai 18 anni possono essere inclusi solo laddove legalmente permesso ed eticamente accettato.
    - Il soggetto ha un familiare/assistente o una persona a stretto contatto che è quotidianamente a conoscenza degli effetti collaterali del soggetto. Questo familiare/assistente o persona a stretto contatto deve accompagnare il soggetto alle visite di studio o essere disponibile per la discussione al telefono.
    - Soggetto con epilessia ben caratterizzata secondo la classificazione ILAE del 1989.
    - Soggetto con epilessia che lo Sperimentatore ritiene avrebbe beneficiato di LEV ma per il quale lo Sperimentatore ha deciso di sospendere LEV a causa di effetti collaterali comportamentali non psicotici in seguito all’introduzione di LEV.
    - Il soggetto sta attualmente ricevendo LEV a una dose compresa tra 1 g/die e 3 g/die ed è attualmente trattato con 2 o 3 AED, incluso LEV.
    - Gli AED concomitanti permessi (fatta eccezione per LEV) e la stimolazione del nervo vago (Vagus Nerve Stimulation, VNS) sono stabili e al dosaggio ottimale per il soggetto da almeno 4 settimane (12 settimane per fenobarbital, fenitoina, e primidone) prima della V1 e ci si aspetta che restino stabili durante i Periodi di screening e trattamento.
    • Soggetto con un peso corporeo ≥40 kg.
    • I soggetti di sesso femminile in età non fertile (in postmenopausa da almeno 2 anni, con ooforectomia bilaterale o legamento delle tube, isterectomia completa) sono idonei. I soggetti di sesso femminile in età fertile sono idonei se usano un metodo contraccettivo accettabile dal punto di vista medico
    E.4Principal exclusion criteria
    Subject has previously participated in this study or subject has previously been assigned to treatment in a study of the medication under investigation in this study-Subject has participated in another study of an investigational medication (or a medical device) within the last 30 days or is currently participating in another study of an investigational medication (or a medical device)-Subject has a history of chronic alcohol or drug abuse within the last year-Subject has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the subject’s ability to participate in this study-Subject has a lifetime history of suicide attempt (including an active, interrupted or aborted attempt), or has had suicidal ideation in the past 6 months. -Subject has a known hypersensitivity to any components of the (IMP) or comparative drugs as stated in this protocol-Subject has history of severe adverse hematologic reaction to any drug-Subject has been receiving LEV at any dose for more than 12 weeks prior to V1-Subject taking any drug that may significantly influence the metabolism of BRV, such as cytochrome P450 potent inducers, except if the dose has been kept stable at least 1 month before V1, and is expected to be kept stable during the Treatment Period-Subject on felbamate with less than 18 months exposure before V1-Subject not able to understand the Informed Consent form, Assent form, or daily record card -Subject has obvious cognitive impairment or mental retardation as per Investigator assessment-Subject whose seizures cannot be reliably counted on a regular basis due to their fast and repetitive occurrence (clusters or flurries)-Subject has history or presence of status epilepticus during the year preceding V1 or during the Screening Period-Subject has history or presence of known psychogenic nonepileptic seizures-Subject has presence of any sign (clinical or imaging techniques) suggesting rapidly progressing (ie, not expected to stay stable during study participation) brain disorder or brain tumor. -Subject has any clinical conditions that impair reliable participation in the study or necessitate the use of medication not allowed by protocol-Subject is suffering from severe cardiovascular disease or peripheral vascular disease-Subject has presence of a terminal illness-subject has presence of a serious infection-Subject has impaired hepatic function: ALT/SGPT (), AST/SGOT (), or alkaline phosphatase of more than 2 times the upper limit of the reference range-Subject has (GGT) values of more than 3 times the upper limit of the reference range. A result of GGT exceeding 3 times the upper limit can be accepted only if attributable to hepatic enzyme induction caused by concomitant antiepileptic treatment -Subject has clinically significant deviations from reference range values for laboratory parameters: creatinine clearance calculated <30mL/min, platelets <100,000/μL, or neutrophil cells <1,800/μL-Subject is pregnant or lactating-Subjects are Investigators, co-Investigators, their spouses or children, or any study collaborators.
    Il soggetto ha precedentemente partecipato a questo studio oppure il soggetto è stato precedentemente assegnato al trattamento in uno studio del farmaco in via di sperimentazione in questo studio-Il soggetto ha partecipato a un altro studio di un farmaco sperimentale (o di un dispositivo medico) negli ultimi 30 giorni o sta attualmente partecipando a un altro studio di un farmaco sperimentale (o di un dispositivo medico). Il soggetto ha un’anamnesi di abuso cronico di alcol o stupefacenti nell’ultimo anno - Il soggetto ha una condizione medica o psichiatrica che, secondo l’opinione dello Sperimentatore, potrebbe pregiudicare o compromettere la capacità del soggetto di partecipare allo studio - Il soggetto ha nell’arco della sua vita un’anamnesi di tentato suicidio (incluso un tentativo attivo, interrotto, o fallito), oppure ha avuto idee suicide negli ultimi 6 mesi. - Il soggetto ha una nota ipersensibilità a uno dei componenti del prodotto medicinale sperimentale, IMP o ai farmaci comparatori, come indicato in questo protocollo.
    Il soggetto ha un’anamnesi di grave reazione ematologica avversa a qualsiasi farmaco - Il soggetto ha ricevuto LEV a qualsiasi dose per oltre 12 settimane prima della V1-Il soggetto assume un farmaco che potrebbe significativamente influenzare il metabolismo di BRV, come potenti induttori del citocromo P450, eccetto laddove la dose sia stata mantenuta stabile per almeno 1 mese prima della V1, e si prevede che venga mantenuta stabile durante il Periodo di trattamento - Il soggetto assume felbamato con meno di 18 mesi di esposizione prima della V1 - Il soggetto non è in grado di comprendere il Modulo di consenso informato, il Modulo di assenso, o le istruzioni della scheda di registrazione giornaliera -Il soggetto ha un’evidente compromissione cognitiva o un evidente ritardo mentale, in base alla valutazione dello Sperimentatore - Soggetto le cui crisi epilettiche non possono essere contate in modo attendibile su base costante a causa della loro manifestazione rapida e ripetitiva (crisi a grappolo o a raffica) -Il soggetto ha un’anamnesi o presenza di stato epilettico durante l’anno precedente alla V1 o durante il Periodo di screening.
    Il soggetto ha un’anamnesi o presenza di crisi non epilettiche psicogene note - Il soggetto mostra la presenza di un segno (tecniche cliniche o per immagini) che suggerisce la rapida progressione (ovvero, che non si prevede resti stabile durante la partecipazione allo studio) di disturbo cerebrale o tumore cerebrale. - Il soggetto ha una condizione clinica () che compromette la partecipazione affidabile allo studio o richiede l’uso di un farmaco non consentito dal protocollo - Il soggetto soffre di una grave patologia cardiovascolare o di malattia vascolare periferica - Il soggetto presenta una malattia terminale - Il soggetto presenta una grave infezione - Il soggetto ha una funzionalità epatica compromessa: ALT/SGPT AST/SGOT (), o fosfatasi alcalina di oltre 2 volte al di sopra del limite superiore dell’intervallo di riferimento -
    Il soggetto presenta valori (GGT) di oltre 3 volte al di sopra del limite superiore dell’intervallo di riferimento. Un risultato di GGT che superi di 3 volte il limite superiore può essere accettato solo se attribuibile all’induzione dell’enzima epatico causata dal concomitante trattamento antiepilettico - Il soggetto presenta deviazioni clinicamente significative dai valori dell’intervallo di riferimento per i parametri di laboratorio: clearance della creatinina calcolata &lt;30 ml/min, piastrine &lt;100.000/μl, oppure cellule neutrofile &lt;1.800/μl-Il soggetto è in gravidanza o allattamento.
    I soggetti sono Sperimentatori, Co-Sperimentatori, relativi coniugi o figli, o collaboratori dello studio.
    E.5 End points
    E.5.1Primary end point(s)
    1)Percentage of subjects who have achieved a clinically meaningful reduction of nonpsychotic behavioral side effects from study entry to the end of the Treatment Period, based on the Investigator's overall assessment.
    2) Entry into the Long-Term Follow Up extension study (N01372)
    1) percentuale di soggetti che hanno ottenuto una riduzione clinicamente significativa degli effetti collaterali comportamentali non psicotici dall’ingresso nello studio alla fine del Periodo di trattamento. La misurazione sarà basata sulla valutazione generale dello Sperimentatore
    2) Inserimento nel Long-Term Follow Up studio di estensione (N01372)
    E.5.1.1Timepoint(s) of evaluation of this end point
    1) Between V2 (Week 0) and Visit 6 (Week 12)
    2) Between V2 (Week 0) and Visit 6 (Week 12)
    1)tra V2(settimana 0)e V6(settimana 12)
    2)tra V2(settimana 0)e V6(settimana 12)
    E.5.2Secondary end point(s)
    The safety and efficacy of BRV will be assessed: - Safety variables include the emergence of a SAEs or TEAEs, withdrawal due to an AE, investigator global evaluation of nonpsychotic behavioural side effects, shift in maximum side effect intensity from baseline to end of treatment, freedom or abatement of nonpsycotice behavioural side effects, laboratory tests (blood chemistry, hematology, urinalysis), vital signs (systolic blood pressure, diastolic blood pressure, heart rate), electrocardiogram (ECG), physical and neurologicals examination. - Efficacy variables include the partial onset seizure (POS) frequency during the treatment period for subjects with focal epilepsy, generalized seizure days during the Treatment Period for subjects with idiopathic generalized epilepsy, investigator and patient global evaluations at the end of the study, and seizure freedom (for all seizure types).
    Saranno valutate l’efficacia e la sicurezza di BRV
    Le variabili di sicurezza includono l’insorgenza di un SAE o TAE, ritiro dovuto ad un evento avverso (EA), valutazione globale dello sperimentatore di effetti collaterali comportamentali non psicotici, la deviazione nella massima intensità dell’effetto collaterale dal Basale alla fine del Periodo di trattamento, ), soppressione completa degli effetti collaterali comportamentali non psicotici, esami di laboratorio (chimica del sangue, ematologia, analisi delle urine), segni vitali (pressione arteriosa sistolica, pressione diastolica, frequenza cardiaca), elettrocardiogramma (ECG), esami fisici e nuerologici.
    Le variabili di efficacia includono la frequenza di crisi a insorgenza parziale (Partial-Onset Seizures, POS) durante il Periodo di trattamento per i soggetti con epilessia focale e i giorni di crisi durante il Periodo di trattamento per i soggetti con epilessia generalizzata valutazioni globali dello sperimentatore e del paziente alla fine dello studio, e assenza di crisi (per tutti i tipi di crisi epilettiche).
    E.5.2.1Timepoint(s) of evaluation of this end point
    The safety and efficacy variables be assessed as specified in the protocol during the treatment period (V0 to V6).
    le varibili di ssicrezza ed efficacia saranno valutate durunte il periodo di trattamento (V0 a V6)come speficicato nel protocollo
    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 Yes
    E.6.13.1Other scope of the trial description
    To evaluate the reduction of nonpsychotic behavioral side effects
    Valutare la riduzion di effetti collaterali comportamentali non psicotici
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    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 Yes
    F.1.1Number of subjects for this age range: 2
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 2
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 106
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2
    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 state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 110
    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)
    The treatment period for the N01395 protocol will last 12 weeks. after
    completion of the Treatment Period at V6 (Week 12), the subject will
    have the possibility to continue receiving BRV by entering the Long
    Term Follow Up (LFTU) study (Protocol N01372, EudraCT 2012-000827-
    42). In case of premature termination or in case the subject does not
    want to continue into LFTU, the subject will enter the Down-Titration
    Period. Refer protocol for further details
    Il periodo di trattamento per il protocollo N01395 durerà 12 settimane. Dopo il completamento del periodo di trattamento al V6 (settimana 12), i soggetti hanno la possibilità di continuare a ricevere BRV entrando nello studio a lungo termine (LFTU) (Protocollo N01372, EudraCT 2012-000827 - 42). In caso di interruzine anticipata o nel caso il soggetto non desiderisi continuare nel LFTU, il soggetto entrerà nel periodo di riduzione del dosaggio. Vedere protocollo per dettagli
    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 Decision2012-06-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-05-18
    P. End of Trial
    P.End of Trial StatusCompleted
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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