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    Summary
    EudraCT Number:2013-003420-37
    Sponsor's Protocol Code Number:A0081042
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-04-11
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2013-003420-37
    A.3Full title of the trial
    A DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, MULTICENTER STUDY OF THE EFFICACY AND SAFETY OF PREGABALIN AS ADJUNCTIVE THERAPY IN CHILDREN 1 MONTH THROUGH <4 YEARS OF AGE WITH PARTIAL ONSET SEIZURES
    ESTUDIO MULTICÉNTRICO, DE GRUPOS PARALELOS, EN DOBLE CIEGO Y CONTROLADO CON PLACEBO, PARA EVALUAR LA EFICACIA Y LA SEGURIDAD DE LA PREGABALINA COMO TRATAMIENTO ADYUVANTE EN NIÑOS DE 1 MES A MENOS DE 4 AÑOS DE EDAD CON CRISIS EPILÉPTICAS PARCIALES
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Safety, Efficacy, and Tolerability Trial of Pregabalin as Add-On Treatment in Pediatric Subjects <4 years of age with Partial Onset seizures.
    Estudio para evaluar la Eficacia, la Seguridad y la Tolerabilidad de la Pregbalina como Tratamento Adyuvante en niños con menos de 4 años de edad con Crisis Epilépticas Parciales.
    A.3.2Name or abbreviated title of the trial where available
    Pregabalin, Phase 3 Study in children < 4 years of age with partial onset seizures
    A.4.1Sponsor's protocol code numberA0081042
    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 SponsorPfizer Inc. 235 East 42nd Street, New York, NY 10017
    B.1.3.4CountryUnited States
    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 supportPfizer Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPfizer Inc
    B.5.2Functional name of contact pointClinical Trials.gov Call Center
    B.5.3 Address:
    B.5.3.1Street Address235 East 42nd Street
    B.5.3.2Town/ cityNew York
    B.5.3.3Post codeNY 10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number0034 91 490 9900
    B.5.5Fax number001 303 7391119
    B.5.6E-mailClinicalTrials.gov_Inquiries@pfizer.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 Lyrica
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Ltd
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 namePregabalin
    D.3.4Pharmaceutical form Oral solution
    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 INNPREGABALIN
    D.3.9.1CAS number 148553-50-8
    D.3.9.2Current sponsor codePD-144,723
    D.3.9.3Other descriptive namePREGABALIN
    D.3.9.4EV Substance CodeSUB10023MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 placeboOral solution
    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
    Partial onset seizures
    Crisis epilépticas parciales
    E.1.1.1Medical condition in easily understood language
    Seizures or epilepsy
    Crisis o epilepsia
    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 16.1
    E.1.2Level LLT
    E.1.2Classification code 10034089
    E.1.2Term Partial seizures NOS
    E.1.2System Organ Class 100000004852
    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 efficacy of two dose levels of pregabalin compared to placebo as an adjunctive treatment in reducing the frequency of partial onset seizures in pediatric subjects 1 month through <4 years of age.
    El objetivo principal de este estudio es evaluar la eficacia de dos niveles de dosis de pregabalina, en comparación con placebo, como tratamiento adyuvante en cuanto a la reducción de la frecuencia de las crisis parciales en sujetos pediátricos de 1 mes a 3 años de edad.
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of pregabalin compared to placebo on the frequency of partial onset seizures as determined by responder rate in pediatric subjects 1 month through <4 years of age.

    To assess the safety and tolerability of pregabalin in pediatric subjects 1 month (44 weeks gestational age) through <4 years of age with partial onset seizures.
    Evaluar la eficacia de la pregabalina, en comparación con placebo, sobre la frecuencia de las crisis parciales, determinada por la tasa de «respondedores», en sujetos pediátricos de 1 mes a 3 años de edad.

    Evaluar la seguridad y la tolerabilidad de la pregabalina en sujetos pediátricos de 1 mes (edad gestacional de 44 semanas) a 3 años de edad con crisis parciales.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Subject must have 3 partial onset seizures in the month prior to screening.
    - Subject must have 2 partial onset seizures during the 48 hour baseline phase.
    - Signed Informed Consent
    - On 1-3 stable anti-eplieptic drugs at screening
    - Los sujetos deben haber tenido al menos 3 crisis observadas en el mes anterior a la selección
    - Los sujetos deben haber tenido al menos 2 crisis parciales durante la fase de 48 horas basal.
    - Documento de consentimiento informado firmado.
    - En una dosis estable de 1 a 3 fármacos antiepilépticos en la selección.
    E.4Principal exclusion criteria
    - Primary generalized seizures including clonic, tonic, clonic-tonic, absence, febrile seizures, and infantile spasms
    - Lennox-Gasteau, BECTS, and Dravet's syndrome
    - Status epliepticus within 1 year of screening
    - Any change in AED regimen with 7 days of screening
    - Progressive structural central nervous system (CNS) lesion or a progressive encepholopathy
    - Progressive errors of metabolism
    - Crisis generalizadas primarias , que pueden incluir, crisis clónicas, tónicas, tónico-clónicas, crisis de ausencia, crisis febriles, y espasmos infantiles.
    - Síndrome de Lennox-Gastaut, epilepsia benigna con puntas centrotemporales y síndrome de Dravet.
    - Estado epiléptico en el año anterior a la selección.
    - Cualquier cambio en el tratamiento antiepiléptico (tipo de medicación o dosis) en los 7 días anteriores a la visita de selección.
    - Lesión estructural progresiva del sistema nervioso central (SNC) o encefalopatía progresiva.
    - Errores del metabolismo progresivos
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint will be the log transformed double blind 24 hr seizure rate for all partial onset seizures collected at Visit 6 (48 hour Video-EEG assessment phase) during the double blind phase as determined by the central reader. This 24-hour seizure rate will be calculated as follows for the double-blind period:

    Double Blind 24 - hr EEG seizure rate = # of seizures in double blind 48 - hr assessment phase \ # of hours of Video - EEG monitoring x 24

    When the log-transformation is used, the quantity 1/28 is added to the double blind 24-hr EEG seizure rate for all subjects to account for any possible "0" seizure incidence. This will result in the following primary efficacy measure: log e (double blind 24-hr EEG seizure rate +1/28). Results will be reported as "percent change in seizures" relative to placebo.

    A minimum of 24 hours of evaluable Video-EEG will be required to utilize the EEG. In cases where there is less than 24 hours of evaluable Video-EEG, the seizure rate will be set to missing.

    The baseline 24-hr EEG seizure rate will be calculated in the same respective manner.
    El criterio principal de valoración será la tasa de crisis en 24 horas en doble ciego, transformada logarítmicamente, de todas las crisis parciales recogidas en la visita 6 (fase de evaluación vídeo EEG de 48 horas) durante la fase en doble ciego, determinada por el lector central. Esta tasa de crisis en 24 horas se calculará de la siguiente manera para la fase en doble ciego:

    Tasa de crisis en el EEG de 24h con doble ciego = nº de crisis en la fase de evaluación de 48h con doble ciego \ nº de horas de monitorización - EEG x24

    Cuando se utiliza la transformación logarítmica, a la tasa de crisis en el EEG de 24 horas en doble ciego se le añade la cantidad 1/28, en todos los sujetos, a fin de tener en cuenta una posible incidencia de "0" crisis, lo que dará lugar a la siguiente variable principal de eficacia: log e (tasa de crisis en el EEG de 24 horas en doble ciego + 1/28).
    Los resultados se comunicarán como "porcentaje de variación de las crisis" respecto al placebo.

    Para utilizar el EEG será necesario disponer de un mínimo de 24 horas de vídeo EEG evaluable. En aquellos casos en los que se disponga de menos de 24 horas de vídeo EEG evaluable, la tasa de crisis se considerará omitida.

    La tasa de crisis del EEG de 24 horas basal se calculará del mismo modo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Visit 6
    Visita 6
    E.5.2Secondary end point(s)
    Responder Rate, defined as subjects who have a ≥50% reduction from baseline in partial seizure rate during the double-blind 48 hour Video-EEG phase. Subjects meeting this criterion will be considered responders.

    The evaluation of safety will include adverse event (AE) data (occurrence, nature, intensity, and relationship to study drug), assessment of clinical laboratory data and the results of physical examinations, vital signs, weight, neurological examinations, and electrocardiograms (ECGs).
    Tasa de «respondedores», lo que se define como sujetos con una reducción de la tasa de crisis parciales durante el periodo de EEG de 48 horas en doble ciego ≥50 % respecto a la basal. Los sujetos que cumplan este criterio se considerarán respondedores.

    La evaluación de la seguridad comprenderá los datos de los acontecimientos adversos (aparición, naturaleza, intensidad y relación con el fármaco del estudio), la evaluación de los datos de las pruebas analíticas y los resultados de las exploraciones físicas, constantes vitales, exploraciones neurológicas y electrocardiogramas (ECG).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Visit 2 - visit 7
    Visita 2 - visita 7
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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
    Tolerability
    Tolerabilidad
    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 trial3
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA56
    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
    Belgium
    Bulgaria
    China
    Croatia
    France
    Germany
    Greece
    Hungary
    Israel
    Italy
    Korea, Republic of
    Malaysia
    Netherlands
    Philippines
    Poland
    Portugal
    Romania
    Serbia
    Singapore
    South Africa
    Spain
    Sweden
    Switzerland
    Taiwan
    Thailand
    Turkey
    Ukraine
    United Kingdom
    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
    Completion of the taper phase of the last patient (LPLV)
    Una vez terminada la fase de disminución progresiva del último paciente (último paciente última visita).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months5
    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: 123
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 80
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 43
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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
    Consent will be obtained from both parents/legal guardians as per local regulations
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 57
    F.4.2.2In the whole clinical trial 123
    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 protocol does not specify any post treatment care, and their next
    line of treatment would be decided by the treating physician.
    El protocolo no especifica ninguna atención después del tratamiento, y su próxima linea de tratamiento se decidirá por el médico que le trate.
    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 Decision2014-07-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-05-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-03-13
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