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    EudraCT Number:2014-002167-16
    Sponsor's Protocol Code Number:E2007-G000-311
    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:2017-01-05
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2014-002167-16
    A.3Full title of the trial
    An Open-Label, Multicenter Study with an Extension Phase to Evaluate the Safety, Tolerability, and Exposure-Efficacy Relationship of Perampanel Oral Suspension when Administered as an Adjunctive Therapy in Pediatric Subjects (Age 4 to less than 12 years) with Inadequately Controlled Partial-Onset Seizures or Primary Generalized Tonic-Clonic Seizures
    Estudio abierto y multicéntrico con una fase de extensión para evaluar la seguridad, la tolerabilidad y la relación exposición-eficacia de perampanel en suspensión oral cuando se administra como tratamiento complementario en sujetos pediátricos (de 4 a menos de 12 años) con crisis de inicio parcial mal controladas o crisis tonicoclónicas generalizadas primarias
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The study being done to see if the Study Drug is safe, tolerable, and can help control seizure in children with epilepsy who are aged 4 to less than 12 years of age and who are already taking seizure medications. The study will also look at pharmacokinetics, which is used to find out the concentration of perampanel in your child’s blood over a period of time.
    El estudio se está llevando a cabo para ver si el medicamento del estudio es seguro, tolerable y puede ayudar a controlar la convulsión en niños con epilepsia que tienen entre 4 y menos de 12 años de edad y que ya están tomando medicamentos para convulsiones. El estudio también examinará la farmacocinética, que se utiliza para averiguar la concentración de perampanel en la sangre de su hijo durante un período de tiempo.
    A.4.1Sponsor's protocol code numberE2007-G000-311
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/118/2016
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorEisai Limited
    B.1.3.4CountryUnited Kingdom
    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 supportEisai Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEisai Europe Ltd.
    B.5.2Functional name of contact pointMedical Information
    B.5.3 Address:
    B.5.3.1Street AddressEuropean Knowledge Centre, Mosquito Way
    B.5.3.2Town/ cityHatfield
    B.5.3.3Post codeAL10 9SN
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+34900834223
    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. name Fycompa
    D. of the Marketing Authorisation holderEisai Europe 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 namePerampanel
    D.3.2Product code E2007
    D.3.4Pharmaceutical form Oral suspension
    D.3.4.1Specific paediatric formulation Yes
    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 INNPerampanel
    D.3.9.1CAS number 380917-97-5
    D.3.9.2Current sponsor codeE2007
    D.3.9.3Other descriptive namePerampanel
    D.3.9.4EV Substance CodeSUB32160
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 Yes
    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
    Epilepsy :
    1) Partial-Onset Seizures (POS)
    2) Primary Generalized Tonic-Clonic Seizures (PGTC)
    1) Crisis de Inicio parcial (CIP)
    2) Crisis Tónicoclónicas Generalizadas Primarias (CTGP)
    E.1.1.1Medical condition in easily understood language
    1) Fits that affect one part of your brain called a “partial seizure”
    2) Certain fits that affect all of your brain from the start called “generalised seizures and cause convulsions or staring spells
    1) Ajustes que afectan una parte de cerebro llamada crisis parcial 2) Ciertos ajustes afectan todo cerebro desde inicio llamado Crisis generalizadas y causan convulsiones o episodios de mirada fija
    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 19.0
    E.1.2Level HLT
    E.1.2Classification code 10018101
    E.1.2Term Generalised tonic-clonic seizures
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10061334
    E.1.2Term Partial seizures
    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 safety and tolerability of perampanel oral suspension when administered as an adjunctive therapy in children (ages 4 to <12 years) with inadequately controlled partial-onset seizures (POS) or primary generalized tonic-clonic seizures (PGTC)
    Evaluar la seguridad y la tolerabilidad de E2007/perampanel en suspensión oral cuando se administra como tratamiento complementario a niños (de 4 a <12 años) con crisis de inicio parcial (CIP) mal controladas o crisis tonicoclónicas generalizadas primarias (CTGP).
    E.2.2Secondary objectives of the trial
    1. Characterize PK of perampanel & the relationship between perampanel plasma concentrations, efficacy & safety using population PK/PD modeling
    2. Evaluate effects of perampanel on cognition, behavior, visuomotor skills & growth & development in children during short-term (23 wks) & long-term (up to 52 wks) treatment
    3. Evaluate frequency of EEG abnormalities during awake & sleep state during 52 wks of treatment
    4. Evaluate suicidal ideation & suicidal behavior in children 6 yrs to less than 12 yrs as measured by the C-SSRS during 52 wks of treatment
    5. Evaluate efficacy of perampanel as measured by the median percent change per 28 days in seizure frequency by the proportion of responders (≥25%, ≥50% & ≥75%) & by the proportion of subjects who are seizure-free for POS, PGTC, & GTC seizures
    6. Evaluate, in Japanese subjects, efficacy of perampanel on POS in this study compared to Placebo in Study E2007-J000-335
    7. Assess effects of perampanel on the CGI, CGIS & CGIC
    1. Caracterizar farmacocinética (FC) perampanel y relación entre concentraciones plasmáticas perampanel, eficacia y seguridad segun FC/FD poblacional.
    2. Evaluar efectos perampanel en fx cognitiva,comportamiento,destrezas visomotoras y crecimiento y desarrollo en niños en tratam corto plazo (23 sem) y largo plazo (52 sem).
    3. Evaluar frecuencia de alteraciones en EEG durante vigilia y sueño en 52 sem tratam.
    4. Evaluar ideación suicida y comportamiento suicida en niños 6 < 12 años, por Escala de valoración riesgo de suicidio de Columbia (C-SSRS), en 52 sem tratam.
    5. Evaluar eficacia perampanel, por mediana variac porcentual en 28 días frecuencia de crisis, por proporción pacientes con resp (≥25%, ≥50% y ≥75%) y proporción de pacientes sin presentar crisis (CIP, CTGP o TCG).
    6. Evaluar, en pacientes japoneses, eficacia perampanel sobre CIP en este estudio, en comparación con placebo en estudio E2007-J000-335.
    7. Evaluar efectos perampanel en CGI, CGIS y CGIC.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Have a diagnosis of epilepsy with POS with or without secondarily generalized seizures or PGTC according to the International League Against Epilepsy’s (ILAE) Classification of Epileptic Seizures (1981). Diagnosis should have been established at least 6 months prior to Visit 1 by clinical history and an EEG that is consistent with the diagnosis; normal interictal EEGs will be allowed provided that the subject meets the other diagnosis criterion (ie, clinical history)
    2. Male or female subject, from age 4 to less than 12 years at the time of informed consent/assent
    3. Have a minimum weight of 16 kg (35 lb)
    4. Have had a brain imaging (eg, magnetic resonance imaging [MRI] scan or computed tomography[CT]) before Visit 1 that ruled out a progressive cause of epilepsy
    5. During the 4 weeks ± 3 days before Visit 2, subjects must have had equal or greater than 1 POS or 1 PGTC seizure. Only simple POS with motor signs, complex POS, and complex POS with secondary generalization are counted toward this inclusion for POS.
    6. Are currently being treated with stable doses of 1 to a maximum of 2 approved AEDs. Doses must be stable for at least 4 weeks before to Visit 1; in the case where a new AED regimen has been initiated for a subject, the dose must be stable for at least 8 weeks prior to Visit 1. Only 1 EIAED (defined as carbamazepine, phenytoin, oxcarbazepine, or eslicarbazepine) out of the maximum of 2 AEDs is allowed (A vagal nerve stimulator [VNS] will be counted as one of the 2 allowed AEDs).
    1. Tener diagnóstico de epilepsia con CIP, con o sin crisis de generalización secundaria o CTGP, según la clasificación de las crisis epilépticas de la Liga Internacional contra la Epilepsia (ILAE) (1981). El diagnóstico se debe haber establecido al menos 6 meses antes de la visita 1 basándose en la historia clínica y en un EEG que sea coherente con el diagnóstico; se permitirán EEG interictales normales siempre que el paciente cumpla el otro criterio diagnóstico (es decir, historia clínica)
    2. Pacientes de ambos sexos, de 4 a menos de 12 años en el momento de obtener el consentimiento/asentimiento informado.
    3. Peso mínimo de 16 kg
    4. Estudio de imagen cerebral (p. ej., resonancia magnética [RM] o tomografía computarizada [TC]) realizado antes de la visita 1 que descartase una causa progresiva de la epilepsia
    5. Durante las 4 semanas ± 3 días anteriores a la visita 2, los pacientes deberán haber tenido como mínimo 1 CIP o 1 crisis CTGP. En este criterio de inclusión, solo se consideran CIP las CIP simples con signos motores, las CIP complejas y las CIP complejas con generalización secundaria.
    6. Estar recibiendo actualmente dosis estables de 1 a un máximo de 2 medicamentos AE aprobados. Las dosis deberán haberse mantenido estables durante al menos 4 semanas antes de la visita 1; en caso de que se haya iniciado una nueva pauta de AE en un paciente, la dosis debe mantenerse estable durante al menos 8 semanas antes de la visita 1 Se permite únicamente 1 AEIE (carbamazepina, fenitoína, oxcarbazepina o eslicarbazepina) entre los 2 AE (los estimuladores del nervio vago [ENV] se contarán como uno de los 2 AE permitidos).
    E.4Principal exclusion criteria
    1. Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive [ß-hCG] or [hCG] test with a minimum sensitivity of 25 IU/L or equivalent units of ß-hCG [or hCG]). A separate baseline assessment is required if a negative screening pregnancy test was obtained >72 hours before the 1st dose of study drug.
    2. Females of childbearing potential who:
    • Had unprotected sexual intercourse within 30 days before study entry & who do not agree to use a highly effective method of contraception ( total abstinence, an intrauterine device, a contraceptive implant, an oral contraceptive, or have a vasectomized partner with confirmed azoospermia) throughout the entire study period or for 28 days after study drug discontinuation. If a highly effective method is not appropriate or acceptable for the subject, then the subject may use a medically effective method (a double barrier method such as condom plus diaphragm with spermicide).
    • Are currently abstinent & do not agree to use a double-barrier method (as above) or refrain from sexually active during the study period or for 28 days after study drug discontinuation.
    • Are using hormonal contraceptives but are not on a stable dose of the same hormonal contraceptive product for at least 4 weeks before dosing & who do not agree to use the same contraceptive during the study or for 28 days after study drug discontinuation.
    3. Current or history of pseudo-seizures (psychogenic nonepileptic seizures) within approximately 5 years before Visit 1.
    4. Have a history of status epilepticus that required hospitalization during the 6 months before to Visit 1.
    5. Have an unstable psychiatric diagnosis that may confound subjects’ ability to participate the study or that may prevent completion of the protocol specified tests (significant suicide risk, including suicidal behavior & ideation within 6 months before Visit 1, current psychotic disorder, acute mania).
    6. Any suicidal ideation with intent with or without a plan within 6 months before Visit 2 (ie answering “Yes” to questions 4 or 5 on the Suicidal Ideation section of the C-SSRS) in subjects aged > 6 years.
    7. Are scheduled and/or confirmed to have epilepsy surgery within 6 months after Visit 1; however, those who have previously documented “failed” epilepsy surgery will be allowed.
    8. Evidence of clinically significant disease (cardiac, respiratory, gastrointestinal, renal disease) that in the opinion of the investigators could affect the subject’s safety or interfere with the study assessments.
    9. Severe renal insufficiency
    10. Evidence of significant active hepatic disease. Stable elevation of liver enzymes, ALT & AST due to concomitant medication(s), will be allowed if they are less than 3 times the ULN.
    11. Evidence of significant active hematological disease;WBC count ≤ 2500/μL (2.50 1E+09/L) or an absolute neutrophil count ≤ 1000/μL (1.00 1E+09/L).
    12. Clinically significant ECG abnormality, including prolonged corrected QT interval defined as > 450 msec.
    13. Have a progressive central nervous system disease, including degenerative CNS diseases & progressive tumors.
    14. Multiple drug allergies or a severe drug reaction to an AEDs, including dermatological (Stevens-Johnson syndrome) haematological or organ toxicity.
    15. Concomitant use of felbamate as an AED for < 2 years or where the dose has not been stable for at least 8 weeks before Visit 1. They must not have a history of WBC count below ≤ 2500/μL (2.50 1E+09/L), platelets < 100,000, liver function tests > 3 times the ULN, or other indication of hepatic or bone marrow dysfunction while receiving felbamate. If subjects received felbamate in the past, it must have been discontinued 8 weeks before Visit 1 to be eligible for study participation.
    16. Concomitant use of vigabatrin: Subjects who took vigabatrin in the past must be off vigabatrin for at least 5 months before Visit 1 & with documentation showing no evidence of a vigabatrin associated clinically significant abnormality in a visual perimetry test.
    17. Used barbiturates (except for seizure control indication) within 4 weeks before to Visit 1.
    18. Used benzodiazepines (other than intermittent rescue use) for epilepsy (or for anxiety or sleep disorders) & for which the dose has not been stable for ≥ 4 weeks before to Visit 1.
    19. A VNS implanted < 5 months before Visit 1 or changes in parameter < 4 weeks before Visit 1 (or thereafter during the study)
    20. On a ketogenic diet for which the diet is not stable regimen for at least 4 weeks before to Visit 1.
    21. History of or a concomitant medical condition that in the opinion of the investigator(s) would preclude the subject's participation in a clinical study or compromise the subject’s ability to safely complete the study.
    22. Have previously been exposed to perampanel in a clinical trial or by prescription for > 2 months or discontinued for AEs.
    1. Mujeres en lactancia o embarazadas en selección o V. basal (determinación positiva [β hCG] o [hCG]) con sensibilidad mín 25 UI/l o ud equivalentes de β-hCG [o hCG]). Se hará otra evaluación en V. basal si prueba de embarazo negativa en selección se obtuvo > 72 horas antes admin de 1ª dosis fármaco estudio.
    2. Mujeres en edad fértil que:
    ● Hayan mantenido sexo sin protección en 30d previos a entrada en estudio sin utilizar mét anticonceptivo muy eficaz (ej, abstinencia total, dispositivo intrauterino, implante anticonceptivo, anticonceptivo oral o vasectomía de la pareja con azoospermia confirmada) en estudio o 28d tras retirada fármaco estudio. Si no es adecuado, o aceptable para paciente, la paciente podrá utilizar mét medicamento eficaz (ej., mét doble barrera como preservativo más diafragma con espermicida).
    ● Practiquen abstinencia y no utilicen mét doble barrera o abstenerse de activ sexual en estudio o tras 28d tras retirada fármaco estudio.
    ● Estén utilizando anticonceptivos hormonales, pero no hayan recibido dosis estable del mismo anticonceptivo hormonal desde 4 sem antes de admin tratam y no utilicen el mismo anticonceptivo en estudio o 28d tras retirada fármaco estudio.
    3. Presencia o antecedentes pseudocrisis (crisis no epilépticas psicógenas) aprox en 5 años previos V1.
    4. Antecedentes de estado epiléptico con necesidad de hospitalización en 6 meses previos a V1.
    5. Diagnóstico psiquiátrico inestable que confunda la capacidad paciente para participar en estudio o que impida realización de pruebas especificadas en protocolo (ej, riesgo significativo de suicidio, con comportamiento e ideación suicidas en 6 meses previos V1, trastorno psicótico actual o manía aguda).
    6. Ideación suicida con intento, con o sin un plan, en 6 meses previos a V2 (es decir, resp "Sí" a preg 4 o 5 de Ideación suicida de la C-SSRS) en pacientes 6 años o más.
    7. Cita prevista o confirmada para intervención quirúrgica por epilepsia en 6 meses tras V1; no obstante, se permitirá la participación de pacientes que tengan documentada una intervención previa "fallida" por epilepsia.
    8. Indicios de enfermedad de importancia clínica (ej., enf cardiaca, respiratoria, digestiva, renal) que, en opinión del investigador, afecten a seguridad paciente o interferir en evaluaciones del estudio.
    9. Insuficiencia renal grave.
    10. Indicios hepatopatía activa significativa. Se permitirá un aumento estable de enzimas hepáticas (ALT) y (AST) debido a med concomitantes si < a 3 veces el (LSN).
    11. Indicios de enfermedad hematológica activa importante; recuento de leucocitos =< 2.500 /µl (2,50 1E+09/l) o recuento absoluto de neutrófilos =< 1000 /µl (1,00 1E+09/l).
    12. Alteración clínicamente significativa en ECG, como prolongación del intervalo QT corregido (QTc), definida como mayor de 450 ms.
    13. Enfermedad progresiva del (SNC), como enfermedades degenerativas y tumores progresivos.
    14. Múltiples alergias a medicamentos o reacción grave a AE, incluidas reacciones dermatológicas (ej., síndrome Stevens-Johnson), hematológicas o toxicidad orgánica
    15. Uso concomitante de felbamato como AE durante < 2 años o en caso de dosis no haya sido estable durante 8 sem antes de V1. Sin antecedentes de recuentos leucocitarios =< 2500/μl (2,50 1E+09/l), recuentos de plaquetas < 100.000/μl, pruebas de función hepática (PFH) > 3 veces el LSN ni ningún otro indicio de disfunción hepática o de médula ósea durante el tratamiento con felbamato. Si pacientes han recibido felbamato en el pasado, deben haberlo suspendido 8 sem antes de V1 para participar en estudio.
    16. Uso concomitante de vigabatrina:Ppacientes tratados con vigabatrina en el pasado deben haber estado sin tomarla aprox 5 meses antes de V1 y deben tener documentación de ausencia de indicios de alteración clínicamente significativa asociada a vigabatrina en prueba de perimetría visual.
    17. Uso de barbitúricos (excepto para el control de crisis) en las 4 sem previas a V1.
    18. Uso de benzodiacepinas (aparte del uso intermitente como rescate) para epilepsia (o ansiedad o trastornos del sueño) cuando la dosis no se haya mantenido estable en 4 sem o más antes de V1.
    19. Sistema de ENV implantado menos de 5 meses antes de V1 o cambios de los parámetros menos de 4 sem antes de V1 (o posteriormente durante el estudio).
    20. Estar siguiendo una dieta cetogénica que no se haya mantenido estable durante 4 sem antes de V1.
    21. Antecedentes o presencia de una enf concomitante que, en opinión del investigador, impida la participación paciente en un estudio clínico o comprometa la capacidad del paciente de completar el estudio de forma segura.
    22. Exposición previa a perampanel en un ensayo clínico o por prescripción durante más de 2 meses o retirada de perampanel por AA.
    E.5 End points
    E.5.1Primary end point(s)
    Safety and tolerability, which include incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), laboratory parameters, vital signs, and ECG parameters, of perampanel oral suspension in children (ages 4 to <7 years and =>7 years to <12 years) with POS or PGTC
    Seguridad y tolerabilidad, que incluyen la incidencia de acontecimientos adversos aparecidos durante el tratamiento (AAAT) y acontecimientos adversos graves (AAG), parámetros analíticos, constantes vitales y parámetros del ECG, de perampanel en suspensión oral en niños (de 4 a <7 años y =>7 a <12 años) con CIP o CTGP.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At the end of the core phase and the extension phase
    Al final de la fase central y la fase de extensión
    E.5.2Secondary end point(s)
    1. The relationship between plasma levels of perampanel and efficacy endpoints (ie, change in average seizure frequency over 28 days, responder probability, and the proportion of subjects who are seizure-free in the Maintenance Period of the Core Study) separately for each seizure type
    2. The relationship between plasma levels of perampanel and cognition endpoints including change from baselines in ABNAS, CBCL, and LGPT. In addition, depending on the AE data, the relationship between plasma levels of perampanel and select AEs will be assessed.
    3. Change from baseline at Week 23 and Week 52 in ABNAS, CBCL, and LGPT
    4. Changes from baseline at Week 23 and Week 52 in growth and development parameters (height, weight, thyroid, and IGF-1)
    5. Change from baseline in EEG and the frequency of EEG abnormalities during awake and sleep state
    6. Proportion of subjects (aged 6 or older at time of consent/assent) with any treatment-emergent reports of suicidal ideation and behavior on the C-SSRS and intensity of these behaviors assessed using C-SSRS scores
    7. The median percent change in seizure frequency per 28 days during Treatment Phase (Titration Period and Maintenance Period) of the Core Study, and during the long-term treatment (up to 52 weeks) relative to the Pretreatment Phase. Seizure frequency will be based on the number of seizures per 28 days, calculated as the number of seizures over the entire time interval divided by the number of days in the interval and multiplied by 28.
    8. Proportion of responders (25% responders defined as a decrease in 28-day seizure frequency of equal or greater than 25% compared to baseline seizure frequency; 50% responders defined as a decrease in 28-day seizure frequency of equal or greater than 50% compared to baseline seizure frequency; 75% responders defined as a decrease in 28-day seizure frequency of equal or greater than 75% compared to baseline seizure frequency) during Maintenance Period of Core Study, and during the long term treatment (up to 52 weeks)
    9. Proportion of subjects who are seizure-free during Maintenance Period of Core Study, and during the long term treatment (up to 52 weeks)
    10. CGI of Change
    1. Relación entre la concentración plasmática de perampanel y los criterios de valoración de la eficacia (es decir, variación de la frecuencia media de crisis durante 28 días, probabilidad de respuesta y proporción de pacientes que no tienen crisis en el periodo de mantenimiento del estudio central) por separado para cada tipo de crisis.
    2. Relación entre la concentración plasmática de perampanel y los criterios de valoración cognitivos, incluida la variación en las evaluaciones ABNAS, CBCL y LGPT con respecto a los valores basales. Además, dependiendo de los datos de AA, se evaluará la relación entre la concentración plasmática de perampanel y determinados AA.
    3. Variación en las evaluaciones ABNAS, CBCL y LGPT entre el momento basal y las semanas 23 y 52.
    4. Variaciones de los parámetros de crecimiento y desarrollo (estatura, peso, tiroides e IGF-1) entre el momento basal y las semanas 23 y 52.
    5. Variación con respecto al momento basal en el EEG y la frecuencia de anomalías del EEG durante la vigilia y durante el sueño.
    6. Proporción de pacientes (de 6 años o más en el momento del consentimiento/asentimiento) que notifican ideación y comportamiento suicidas en la escala C-SSRS aparecidos durante el tratamiento e intensidad de estos comportamientos evaluada con la escala C-SSRS.
    7. Mediana de variación porcentual de la frecuencia de crisis por 28 días durante la fase de tratamiento (periodo de ajuste de la dosis y periodo de mantenimiento) del estudio central y durante el tratamiento a largo plazo (hasta 52 semanas) con respecto a la fase de pretratamiento. La frecuencia de las crisis se basará en el número de crisis por 28 días, que se calculará como el número de crisis durante todo el intervalo dividido entre el número de días del intervalo y multiplicado por 28.
    8. Proporción de pacientes con respuesta (respuesta del 25%, definida como una reducción en la frecuencia de convulsiones en 28 días igual o superior al 25% en comparación con la frecuencia basal; respuesta del 50%, definida como una reducción en la frecuencia de convulsiones en 28 días igual o superior al 50% en comparación con la frecuencia basal; respuesta del 75%, definida como una reducción en la frecuencia de convulsiones en 28 días igual o superior al 75% en comparación con la frecuencia basal) durante el periodo de mantenimiento del estudio central y durante el tratamiento a largo plazo (hasta 52 semanas).
    9. Proporción de pacientes que permanecen sin crisis durante el período de mantenimiento del estudio central y durante el tratamiento a largo plazo (hasta 52 semanas).
    10. CGI de la variación.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At the end of the core phase and the extension phase
    Al final de la fase central y la fase de extensión
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    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
    Exposure-Efficacy relationship
    Relación Exposición - Eficacia
    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. 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) No
    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 EEA40
    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
    Korea, Republic of
    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
    Ultima visita, ultimo paciente
    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 months8
    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 months8
    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: 160
    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) Yes
    F. of subjects for this age range: 160
    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 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. of subjects incapable of giving consent
    Subjects are children aged between 4 to <12 years of age at study enrolment
    Los pacientes son niños de 4 a menos de 12 años de edad en el momento del reclutamiento en el estudio.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 160
    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)
    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 Decision2017-02-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-12-01
    P. End of Trial
    P.End of Trial StatusCompleted
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