ESTUDIO ALEATORIZADO, DOBLE CIEGO, CONTROLADO CON PLACEBO Y DE GRUPOS PARALELOS CON UNA FASE DE EXTENSION ABIERTA PARA EVALUAR EL EFECTO DE PERAMPANEL (E2007) EN LA COGNICION, EL CRECIMIENTO, LA SEGURIDAD, LA TOLERABILIDAD Y LA FARMACOCINETICA CUANDO SE A DMINISTRA COMO TERAPIA ADYUVANTE EN ADOLESCENTES ( DE 12 A MENOS DE 18 AÑOS DE EDAD) CON CRISIS DE INICIO PARCIAL INSUFICIENTEMENTE CONTROLADAS.

Datos básicos

Protocolo:
E2007-G000-235
EUDRACT:
2010-018518-56
NCT:
Centro:
HOSPITAL UNIVERSITARI I POLITÈCNIC LA FE
Año de incio:
2011
Año de finalización:
2014
ENSAYO CLÍNICO INTERNACIONAL

Objetivos del proyecto

Observaciones: Estado Comité: FINALIZADO

Documentos

  • No hay documentos

Participantes

Financiadores - Promotores

EISAI LIMITED

Resultados del Ensayo Clínico


A survey of the European Reference Network EpiCARE on clinical practice for selected rare epilepsies.

Baumgartner T; (...); Sadowski K

Article. 10.1002/epi4.12459. 2021

  • Open Access.

Aplicación de la farmacoeconomía en la gestión clínica.

Amat Díaz M, Poveda Andrés JL, Carrera-Hueso FJ

Article. 10.1016/S1130-6343(11)70018-6. 2011

  • Open Access.

Assessment of the effectiveness and safety of natalizumab for treating relapsing-remitting multiple sclerosis.

Fernández-Megía MJ; (...); Poveda-Andrés JL

Article. 10.1016/j.farma.2010.02.003. 2011

  • Open Access.

Assessment of the in vivo formation of biofilm on external ventricular drainages.

Ramírez P; (...); Bonastre J

Article. 10.1007/s10096-013-1895-8. 2013


Cannabidiol therapy for refractory epilepsy in paediatric real world setting: What's the benefit?

Smeyers, P.; (...); Hernandez, S.

Meeting Abstract. 2024


Cognitive adverse events of adjunctive eslicarbazepine acetate in children with refractory focal seizures

Smeyers, P.; (...); Gama, H.

Meeting Abstract. 2022


Cognitive and Behavioral Effects of Adjunctive Brivaracetam in Children and Adolescents with Focal Seizures: Final Data From an Open-label Follow-up Trial

Elshoff, Jan-Peer; (...); Smeyers, Patricia

Meeting Abstract. 10.1212/WNL.0000000000201877. 2023


Combination of Corpus Callosotomy and Vagus Nerve Stimulation in the Treatment of Refractory Epilepsy

Guillamon, E; (...); Villanueva, V

Article. 10.1159/000353979. 2014


Cost-effectiveness of buccal midazolam in the treatment of prolonged convulsive seizures in the outpatient setting in Spain

Raspall-Chaure, M; (...); Cebollero, MA

Article. 10.33588/rn.5811.2014057. 2014


EFFECT OF CYP3A5 GENOTYPE ON TACROLIMUS DOSE REQUIREMENT, NEPHROTOXICITY AND ACUTE REJECTION IN KIDNEY TRANSPLANTATION: A SYSTEMATIC REVIEW AND META-ANALYSIS OF OBSERVATIONAL STUDIES

Rojas, L.; (...); Alino, S. F.

Article. 2013


EFFECTS OF POLYMORPHIMS OF CYP3A5 AND ABCB1 GENES ON CHRONIC NEPHROPATHY: COHORT STUDY

Rojas, L.; (...); Alino, S. F.

Article. 2013


EFFICACY AND SAFETY OF PERAMPANEL AS ADJUNCTIVE THERAPY IN ADOLESCENTS WITH REFRACTORY PARTIAL-ONSET SEIZURES: ANALYSIS OF A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE III STUDY

Villanueva, V.; (...); Laurenza, A.

Article. 2011


Estudio de utilizacion de boceprevir y telaprevir para el tratamiento de la hepatitis C cronica.

Marrero-Álvarez P; (...); Poveda-Andrés JL

Abstract of Published Item. 10.7399/FH.2014.38.1.1128. 2014

  • Open Access.

Increased hospital stay and allograft dysfunction in renal transplant recipients with Cyp2c19 AA variant in SNP rs4244285.

Bosó V; (...); Aliño SF

Article. 10.1124/dmd.112.047977. 2013


Meta-analysis and systematic review of the effect of the donor and recipient CYP3A5 6986A>G genotype on tacrolimus dose requirements in liver transplantation.

Rojas LE; (...); Aliño SF

Article. 10.1097/FPC.0b013e3283642fb3. 2013


Mitochondrial developmental encephalopathy with bilateral optic neuropathy related to homozygous variants in IMMT gene.

Marco-Hernández AV; (...); Martínez-Castellano F

Article. 10.1111/cge.14093. 2022


Monitorización de errores de medicación en dispensación individualizada mediante el método del carro centinela.

Pérez-Cebrián M; (...); Poveda-Andrés JL

Abstract of Published Item. 10.1016/j.farma.2010.06.004. 2011

  • Open Access.

Paclitaxel and carboplatin treatment for advanced ovarian cancer during pregnancy.

Ruiz Ramos J; (...); Poveda JL

Article. 10.1159/000360691. 2013


Papel del acetato de eslicarbazepina en el tratamiento de la epilepsia de origen focal en la edad pediátrica: consideraciones prácticas.

García-Peñas JJ; (...); Aparicio J

Review. 10.33588/rn.71s01.2020562. 2020


Peripheral nerve hyperexcitability: a clinical and immunologic study of 38 patients.

Ramírez P; (...); Bataller L

Article. 10.1212/WNL.0b013e3182061b1e. 2011


Renal Transplantation Recipients with AA Genotype in SNP rs4244285 of CYP2C19 Show An Increase in Hospital Stay Duration and Allograft Dysfunction Probably Due to Increased Tacrolimus Levels Caused by Interaction with Omeprazol

Boso, V; (...); Alino, S. F.

Article. 10.1097/00007890-201211271-01757. 2012


Selective ophthalmic intra-arterial melphalan therapy for advanced retinoblastoma: implementation and outcomes of a new chemotherapy protocol.

Valero García S; (...); Poveda Andrés JL

Article. 10.1177/1078155212457964. 2013


Severe Communication Delays Are Independent of Seizure Burden and Persist Despite Contemporary Treatments in SCN1A+ Dravet Syndrome: Insights from the ENVISION Natural History Study.

Perry, M. Scott; (...); Rico, Salvador

Article. 10.1111/epi.17850. 2023

  • Open Access.

SNPs and taxane toxicity in breast cancer patients

Bosó V; (...); Aliño SF

Article. 10.2217/PGS.14.127. 2014


Treatment adherence and other patient-reported outcomes as cost determinants in multiple sclerosis: a review of the literature

Lizan, L; (...); Polanco, C

Review. 10.2147/PPA.S67253. 2014

  • Open Access.

Triplication of the PCDH19 Gene as a Novel Disease Mechanism Leading to Epileptic Encephalopathy Resembling Loss-of-Function Pathogenic Variants.

Gabaldón-Albero A; (...); Martínez F

Article. 10.3390/genes15101312. 2024

  • Open Access.

Uso benzodiacepinas en crisis prolongadas y estado epileptico en la comunidad.

Sanchez-Carpintero R; (...); Cebollero MA

Article. 10.1016/j.anpedi.2014.03.023. 2014


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