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    Summary
    EudraCT Number:2010-019765-28
    Sponsor's Protocol Code Number:SP0993
    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:2011-12-29
    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 number2010-019765-28
    A.3Full title of the trial
    A MULTICENTER, DOUBLE BLIND, DOUBLE DUMMY, RANDOMIZED, POSITIVE CONTROLLED STUDY COMPARING THE EFFICACY AND SAFETY OF LACOSAMIDE (200 TO 600MG/DAY) TO CONTROLLED RELEASE CARBAMAZEPINE (400 TO 1200MG/DAY), USED AS MONOTHERAPY IN SUBJECTS (≥16 YEARS) NEWLY OR RECENTLY DIAGNOSED WITH EPILEPSY AND EXPERIENCING PARTIAL ONSET OR GENERALIZED TONIC CLONIC SEIZURES
    Studio multicentrico, in doppio cieco e double-dummy, randomizzato e con controllo positivo, per confrontare l'efficacia e la sicurezza di lacosamide (200 - 600 mg/die) e di carbamazepina a rilascio controllato (400 - 1200 mg/die) in monoterapia in soggetti(maggiore o uguale a 16 anni) con epilessia di nuova o recente diagnosi e con crisi epilettiche parziali o tonico-cloniche generalizzate.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study investigating lacosamide- already approved by the European Medicines Agency as add on therapy for the treatment of partial-onset seizures in a new indication- in patients with new or recently diagnosed with epilepsy and experiencing partial-onset or generalized tonic-clonic seizures. Study has two groups: One group of patients will be treated with lacosamide + placebo and a second one with carbamazepine + placebo. Neither the patient nor t
    Lo studio investiga il lacosamide - gia' approvato dall'Agenzia Europea dei Medicinali come terapia addizionale per il trattamento di epilessia nuova o di recente diagnosi in una nuova indicazione- in pazienti con nuova o recente diagnosi di epilessia con crisi epilettiche parziali o tonico-cloniche generalizzate.Lo studio ha due gruppi: uno gruppo di pazienti sara' trattatocon lacasamide +placebo ed il secondo con carbamazepina+placebo....
    A.4.1Sponsor's protocol code numberSP0993
    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 BIOSCIENCES GMBH
    B.1.3.4CountryGermany
    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 BIOSCIENCES GmbH
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportEdev S.a'.r.l.
    B.4.2CountryLuxembourg
    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 point.....
    B.5.3 Address:
    B.5.3.1Street AddressAlfred-Nobel-Strasse 10
    B.5.3.2Town/ cityMonheim
    B.5.3.3Post code40798
    B.5.3.4CountryGermany
    B.5.4Telephone number+49 2173 48 1095
    B.5.5Fax number+49 2173 48 1572
    B.5.6E-mailMaria-Luise.Esch@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 Yes
    D.2.1.1.1Trade name Vimpat
    D.2.1.1.2Name of the Marketing Authorisation holderUCB Pharma S.A
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 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 INNLACOSAMIDE
    D.3.9.1CAS number 175481-36-4
    D.3.9.2Current sponsor codeSPM927
    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.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 Tegretol Retard
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Pharmaceuticals UK Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 Prolonged-release 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.3.9.1CAS number 298-46-4
    D.3.9.3Other descriptive nameCARBAMAZEPINE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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: 3
    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 Vimpat
    D.2.1.1.2Name of the Marketing Authorisation holderUCB Pharma S.A
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 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 INNLACOSAMIDE
    D.3.9.1CAS number 175481-36-4
    D.3.9.2Current sponsor codeSPM927
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Epilepsy, partial onset or generalised tonic-clonic seizures.
    Epilessia,in soggetti con nuova o recente diagnosi di epilessia e con crisi epilettiche parziali (POS) o tonico-cloniche generalizzate.
    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
    The objective of this study is to compare the efficacy and safety of Lacosamide (LCM) (200 to 600mg/day) to Carbamazepine Controlled release CBZ CR (400 to 1200mg/day) used as monotherapy for at least 1 year, efficacy being measured as a primary endpoint by 6 month seizure freedom, in newly or recently diagnosed epilepsy subjects. The study will employ a noninferiority design to show at least a similar benefit risk balance for LCM compared with CBZ CR, using 6-month seizure freedom as primary endpoint.
    L'obiettivo primario di questo studio è confrontare l'efficacia e la sicurezza di lacosamide (LCM) (200 - 600 mg/die) e di carbamazepina a rilascio controllato (CBZ-CR) (400 - 1200 mg/die), utilizzate in monoterapia per almeno 1 anno. L'efficacia è misurata come endpoint primario utilizzando come parametro l'assenza di crisi epilettiche per 6 mesi, in soggetti epilettici diagnosticati de novo o di recente. Lo studio utilizzerà un disegno di non inferiorità per dimostrare un bilancio rischio-beneficio quantomeno analogo per LCM rispetto a CBZ-CR, avvalendosi della libertà da crisi epilettiche per 6 mesi quale endpoint primario.
    E.2.2Secondary objectives of the trial
    4.1.2 Other efficacy variables Other efficacy variables are as follows:• Proportion of subjects remaining seizure free for 12 consecutive months of treatment following stabilization at the last evaluated dose for each subject; • Retention rate evaluated as time to withdrawal of treatment due to AE or lack of efficacy(LOE) relative to the first dose of study medication;• Time to first seizure or discontinuation due to AE/LOE during 12 months of treatment following stabilization at the first evaluated dose for each subject...continue;4.2.2 Other safety variables.The other safety variables are as follows: • Changes in hematology, chemistry, and urinalysis parameters;• Changes in 12-lead electrocardiograms (ECGs); • Changes in vital sign measurements (ie, blood pressure [BP] and pulse rate).....continue.
    Prot. sez.4.1.2 Altre variabili di efficacia sono come segue:•Percentuale di soggetti che rimangono liberi da crisi epilettiche per 12 mesi consecutivi di trattamento, dopo stabilizzazione all'ultima dose valutata per ciascun soggetto;•Tasso di ritenzione valutato come tempo alla sospensione del trattamento a causa di evento avverso (AE) o mancanza di efficacia (LOE) rispetto alla prima dose del medicinale in studio;•Tempo alla prima crisi epilettica o sospensione del trattamento a causa di AE/LOE durante 12 mesi di trattamento, dopo stabilizzazione alla prima dose valutata per ciascun soggetto...continua;Prot.sez.4.2.2 Le altre variabili di sicurezza sono le seguenti:•Alterazioni dei parametri ematologici, chimici e urinari; •Cambiamenti negli ECG a 12 derivazioni;•Variazioni dei parametri vitali (ossia pressione arteriosa [BP] e frequenza del polso);...continua.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects must fulfill the following inclusion criteria to be eligible to participate in this study: 1. An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent form is signed and dated by the subject or by the parent(s) or legal representative. The Consent form or a specific Assent form, where required, will be signed and dated by minors. 2. Subject is willing and able to comply with all study requirements. 3. Subject is male or female and ≥16 years of age. Minors will be included in some countries only if legally permitted. 4. Subject has newly or recently diagnosed epilepsy having experienced unprovoked POS (IA, IB, IC with clear focal origin) or generalized tonic-clonic seizures (without clear focal origin) that are classifiable according to the ILAE Classification of Epileptic Seizures, 1981. The discrimination between IC and IIE is not requested for inclusion. 5. Subject has experienced at least 2 unprovoked seizures (separated by a minimum of 48 hours) in the year preceding randomization out of which at least 1 unprovoked seizure occurred in the 3 months preceding randomization. 6. Subject has had an electroencephalogram (EEG) (that is normal or consistent with the diagnosis of partial-onset epilepsy) and a brain computed tomography (CT) scan or magnetic resonance imaging (MRI) exam of the brain consistent with the diagnosis of partial onset or generalized tonic-clonic seizures (without clear focal origin) within the past year. If the EEG and brain CT scan or MRI exam were not performed prior to Visit 1, they need to be completed and results must be available prior to randomization at Visit 2. E.
    eleggibili alla partecipazione a questo studio: 1. Un modulo di consenso informato, in forma scritta e approvato dal Comitato Etico Indipendente (IEC), è stato firmato e datato dal soggetto o dal suo genitore (o genitori) o rappresentante legale. Il modulo di consenso o uno specifico modulo di assenso, ove necessario, sarà firmato e datato dai soggetti minorenni. 2. Il soggetto è disposto e in grado di soddisfare tutti i requisiti dello studio. 3. Il soggetto è maschio o femmina e la sua età è maggiore o uguale a 16 anni. Solo se consentito a norma di legge, in alcuni paesi saranno inclusi soggetti minorenni. 4. Il soggetto ha una diagnosi nuova o recente di epilessia e ha avuto POS non provocate (IA, IB, IC con chiara origine focale) o crisi epilettiche tonico-cloniche generalizzate (senza una chiara origine focale) classificabili secondo le linee guida ILAE Classification of Epileptic Seizures, 1981. Per l'inclusione non è necessaria alcuna distinzione fra IC e IIE. 5. Il soggetto ha avuto almeno 2 crisi epilettiche non provocate (a distanza di almeno 48 ore) nell'anno che precede la randomizzazione, di cui almeno 1 crisi non provocata avvenuta nei 3 mesi precedenti la randomizzazione. 6. Il soggetto è stato sottoposto ad encefalogramma (EEG) (che appare normale e coerente con la diagnosi di epilessia parziale) e a una tomografia computerizzata (TAC cerebrale o risonanza magnetica (RM) dell'encefalo, coerente con la diagnosi di crisi epilettiche parziali o tonico-cloniche generalizzate (senza una chiara origine focale) durante l’ultimo anno. Se EEG e TAC o RM cerebrale non sono stati effettuati prima della Visita 1, occorrerà eseguirli e gli esiti devono essere disponibili prima della randomizzazione alla Visita 2.
    E.4Principal exclusion criteria
    Subjects are not permitted to enroll in the study if any of the following criteria are met: 1. Subject has previously participated in this study or subject has previously been assigned to treatment in a study of the drugs under investigation in this study. 2. Subject is currently participating or has participated within the last 2 months in any study of an investigational drug or experimental device. 3. Subject has a history or presence of seizures of other types than partial-onset (IA, IB, IC with clear focal origin) and generalized tonic-clonic (without clear focal origin) seizures (eg, myoclonic, absence). 4. Subject has a history or presence of seizures occurring only in clustered patterns, defined as repeated seizures occurring over a short period of time (ie, <20 minutes) with or without function regained between 2 ictal events.5. Subject has a history, clinical, or EEG finding suggestive of idiopathic generalized epilepsy (IGE) at randomization (according to the ILAE Classification of Epileptic Seizures, 1989). 6. Subject has current or previous diagnosis of pseudoseizures, conversion disorders, or other nonepileptic ictal events which could be confused with seizures. 7. Subject has any medical or psychiatric condition, which in the opinion of the investigator, could jeopardize the subject’s health or would compromise the subject’s ability to participate in this study. 8. Subject has a history of suicide attempt, has received professional counseling for suicidal ideation, or is currently experiencing active suicidal ideation. 9. Subject has a known hypersensitivity to any components of the investigational product(s). 10. Subject has ever been treated (for any indication) with LCM or CBZ in the past. 11. Subject has been treated for epilepsy with any AED (including benzodiazepines) in the last 6 months before Visit 1. • However, acute and subacute seizure treatment is accepted with a maximum of 2 weeks duration and if treatment was stopped at least 1 week before Visit 1. • Prior use of felbamate or vigabatrin is not allowed. • Benzodiazepines as rescue therapy for epilepsy may have been used as needed in this time period, but not more frequently than once per week. 12. Subject has received treatment with phenobarbital or primidone within 28 days prior to Visit 1. 13. Subject is taking benzodiazepines for a nonepilepsy indication. 14. The use of monoamine oxidase inhibitors (MAOIs) is not allowed within 14 days of Visit 1. 15. Subject has experienced seizure(s) while treated with any AED for an indication other than epilepsy. 16. Subject is taking any drug or product (eg, grapefruit) that may influence CBZ metabolism. 17. Subject has a known history of severe anaphylactic reaction, serious blood dyscrasias, or hepatic porphyrias. 18. Subject has an acute or sub-acutely progressive central nervous system disease. 19. Subject has alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin levels ≥2× the upper limit of normal (ULN) or has alkaline phosphatase levels ≥3× the ULN. 20. Subject has a medical condition that could reasonably be expected to interfere with drug absorption, distribution, metabolism, or excretion. 21. Subject has a history of alcohol or drug abuse within the previous 2 years. 22. Subject is of Asian ancestry and tests positive for HLA-B*1502 allele. 23. Subject has impaired renal function, ie, creatinine clearance (CLcr) is lower than 30mL/min at Visit 1. Creatinine clearance will be estimated as follows: Adult males: CLcr=(140-age)×weight in kg/(72×serum creatinine in mg/dL) Adult females: CLcr=[(140-age)×weight in kg/(72×serum creatinine in mg/dL)]×0.85 24. Subject has sick sinus syndrome without a pacemaker, or second- or third-degree atrioventricular (AV) block,or subject has any other clinically significant ECG abnormalities.Segue
    Ai soggetti non è permesso l’arruolamento nello studio se soddisfano uno qualsiasi dei criteri seguenti: 1. Il soggetto ha partecipato in precedenza a questo studio, o è stato precedentemente assegnato al trattamento all'interno di uno studio sui farmaci esaminati nell'ambito del presente studio. 2. Attualmente il soggetto partecipa, oppure ha partecipato negli ultimi 2 mesi, a qualunque studio su un farmaco o un dispositivo di tipo sperimentale. 3. Il soggetto evidenzia anamnesi, oppure presenza, di crisi epilettiche tipologicamente diverse dalle crisi parziali (IA, IB, IC con chiara origine focale) e tonico-cloniche generalizzate (senza una chiara origine focale) (per es. miocloniche, di assenza). 4. Il soggetto evidenzia anamnesi, oppure presenza, di crisi epiletticheche si verificano esclusivamente in pattern a grappolo, definite come crisi ripetute insorte nell'arco di un breve periodo di tempo (ossia &lt;20 minuti), con o senza recupero della funzione tra 2 eventi ictali. 5. Il soggetto presenta anamnesi o esiti clinici o encefalografici che suggeriscono epilessia idiopatica generalizzata (IGE) alla randomizzazione (sulla base delle linee guida ILAE Classification of Epileptic Seizures, 1989). 6. Il soggetto presenta una diagnosi attuale o pregressa di pseudocrisi, disturbi di conversione o altri eventi ictali non epilettici che possono essere confusi con crisi epilettiche. 7. Il soggetto soffre di una condizione medica o psichiatrica che, a giudizio dello sperimentatore, potrebbe compromettere la sua salute o la sua capacità di partecipare a questo studio.Segue.
    E.5 End points
    E.5.1Primary end point(s)
    •Proportion of subjects remaining seizure free for 6 consecutive months (26 consecutive weeks) of treatment following stabilization at the last evaluated dose for each subject.The primary safety variables are as follows• AEs reported spontaneously by the subject and/or caregiver or observed by the investigator • Subject withdrawals due to AEs • Serious AEs (SAEs)
    • Percentuale di soggetti che rimangono liberi da crisi epilettiche per 6 mesi consecutivi (26 settimane consecutive) di trattamento, dopo stabilizzazione all'ultima dose valutata per ciascun soggetto.• AE segnalati spontaneamente dal soggetto e/o da chi se ne prende cura, oppure osservati dallo sperimentatore.Le variabili primarie di sicurezza sono le seguenti:• Ritiri dei soggetti a causa di AE • AE gravi (SAE)
    E.5.1.1Timepoint(s) of evaluation of this end point
    26 mesi
    26 mesi
    E.5.2Secondary end point(s)
    Proportion of subjects remaining seizure free for 12 consecutive months of treatment following stabilization at the last evaluated dose for each subject • Retention rate evaluated as time to withdrawal of treatment due to AE or lack of efficacy (LOE) relative to the first dose of study medication • Time to first seizure or discontinuation due to AE/LOE during 12 months of treatment following stabilization at the first evaluated dose for each subject • Time to first seizure or discontinuation due to AE/LOE during 12 months of treatment following stabilization at the last evaluated dose for each subject • Time to first seizure during 12 months of treatment from the first dose of study medication • Time to first seizure or discontinuation during 12 months of treatment from the first dose of study medication Safety variables are as follows: • Changes in hematology, chemistry, and urinalysis parameters Changes in 12-lead electrocardiograms (ECGs) • Changes in vital sign measurements (ie, blood pressure [BP] and pulse rate) • Changes in physical or neurological examination findings • Changes in body weight • Changes in fasting serum lipid levels, and thyroid and sex hormone concentrations
    Altre variabili di efficacia sono come segue:•Percentuale di soggetti che rimangono liberi da crisi epilettiche per 12 mesi consecutivi di trattamento, dopo stabilizzazione all'ultima dose valutata per ciascun soggetto;•Tasso di ritenzione valutato come tempo alla sospensione del trattamento a causa di evento avverso (AE) o mancanza di efficacia (LOE) rispetto alla prima dose del medicinale in studio;•Tempo alla prima crisi epilettica o sospensione del trattamento a causa di AE/LOE durante 12 mesi di trattamento, dopo stabilizzazione alla prima dose valutata per ciascun soggetto; •Tempo alla prima crisi epilettica o sospensione a causa di AE/LOE durante 12 mesi di trattamento, dopo stabilizzazione all'ultima dose valutata per ciascun soggetto; •Tempo alla prima crisi epilettica durante 12 mesi di trattamento, dalla prima dose del medicinale in studio; •Tempo alla prima crisi epilettica o sospensione durante 12 mesi di trattamento, dalla prima dose del medicinale in studio.Le altre variabili di sicurezza sono le seguenti:•Alterazioni dei parametri ematologici, chimici e urinari •Cambiamenti negli ECG a 12 derivazioni;•Variazioni dei parametri vitali (ossia pressione arteriosa [BP] e frequenza del polso); •Cambiamenti negli esiti degli esami obiettivi o neurologici;•Variazioni ponderali;•Cambiamenti nei livelli del lipidi sierici a digiuno, e nelle concentrazioni di ormoni tiroidei e sessuali.
    E.5.2.1Timepoint(s) of evaluation of this end point
    End of trial.
    Termine dello studio.
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    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 Yes
    E.8.1.7.1Other trial design description
    double dummy
    double dummy
    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 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA115
    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
    Australia
    Canada
    Mexico
    Russian Federation
    Ukraine
    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 months39
    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 months39
    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: 50
    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: 50
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 850
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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
    Minors that are included in the study.
    Minori che sono inclusi nello studio.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state42
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 825
    F.4.2.2In the whole clinical trial 1000
    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)
    8.6. End of Study Phase Subjects who prematurely withdraw from SP0993 participation or opt to withdraw from study medication at the end of the Maintenance Phase will then begin the End of Study Phase. In the case of study medication withdrawal and down-titration, the investigator is allowed to add any other AED during the End of Study Phase, following the investigator’s medical judgment. The End of Study Phase will consist of an End of Taper Visit and Final Visit. A Final Visit will
    8.6 FasediConclusione dello studio. I soggetti che prematuramente si ritireranno dallo studio SP0993 o che opteranno per l’abbandono del farmaco in studio al termine della Fase di Mantenimento, inizieranno la Fasedi Conclusionedello Studio. In caso di abbandono e riduzione graduale del farmaco in studio, a seguito del giudizio medico è permesso allo Sperimentatore aggiungere qualsiasi altro farmaco anti-epilettico. La FasediConclusione dello studio consisterà in una Visita Final
    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 Decision2011-09-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-07-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-08-07
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