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Proyectos y Estudios
Estudio multicéntrico, aleatorizado, doble ciego, controlado con placebo y de grupos paralelos para evaluar la eficacia, la seguridad y la tolerabilidad de soticlestat como tratamiento adyuvante en sujetos pediátricos y en adultos con síndrome de Lennox-Gastaut (SLG)

Estudio multicéntrico, aleatorizado, doble ciego, controlado con placebo y de grupos paralelos para evaluar la eficacia, la seguridad y la tolerabilidad de soticlestat como tratamiento adyuvante en sujetos pediátricos y en adultos con síndrome de Lennox-Gastaut (SLG)

Datos básicos

Protocolo:: TAK-935-3002
EUDRACT:: 2021-002481-40
NCT:
Centro:: HOSPITAL UNIVERSITARI I POLITÈCNIC LA FE
Año de incio:: 2021
Año de finalización:: 2023

ENSAYO CLÍNICO

Objetivos del proyecto

Objetivo Principal: Evaluar la eficacia del soticlestat en la reducción de la frecuencia de crisis atónicas generalizadas como tratamiento complementario del tratamiento de referencia en comparación con un placebo durante el periodo completo de tratamiento (ajuste + mantenimiento). Para el registro en la Agencia Europea de Medicamentos (EMA): Evaluar la eficacia del soticlestat en la reducción de la frecuencia de las crisis atónicas generalizadas como tratamiento complementario del tratamiento de referencia en comparación con un placebo únicamente durante el periodo de mantenimiento. Objetivos Secundarios: Evaluar lo siguiente en sujetos tratados con soticlestat en comparación con placebo:-Proporción pacientes con respuesta al tratamiento, definida como aquellos con reducción =50 % de crisis atónicas generalizadas con respecto momento basal durante periodo de mantenimiento y tratamiento completo. -Efecto sobre frecuencia total de crisis de todos los tipos durante periodo de mantenimiento y periodo de tratamiento completo. -Variación con respecto al momento basal de proporción de días sin crisis atónicas generalizadas -Mayor intervalo sin crisis atónicas generalizadas. -Número días en que utilizan antiepilépticos de rescate. -Efecto en la Impresión clínica global de mejoría; por médico y la Impresión global de mejoría según el cuidador. -Efecto sobre intensidad y la duración de las crisis de la CGI-I. -Efecto en los síntomas no convulsivos de la CGI-I completado por médico con la información aportada por los cuidadores. -Efecto en el cuestionario de calidad de vida-discapacidad.

Documentos

No hay documentos

Participantes

Mercedes Garcés Sánchez

Investigador Colaborador
Patricia Smeyers Dura

Investigador Colaborador
José Luis Poveda Andrés

Investigador Colaborador
Jorge Vila Arteaga

Investigador Colaborador
Vicente Enrique Villanueva Haba

Investigador Principal
Honorio Barranco González

Investigador Colaborador
Anselmo Feliciano Sanchez

Investigador Colaborador
Kevin Gill Hampel

Investigador Colaborador
Debora Sayas Gilabert

Data Manager / Study Coordinator

Grupos

Farmacogenética

Investigador Principal

María José Herrero Cervera
Unidad de Descubrimiento de Fármacos (UDF)

Investigador Principal

Leonor Puchades Carrasco
Grupo de Investigación de Farmacia

Investigador Principal

Javier García Pellicer

Financiadores - Promotores

TAKEDA PHARMACEUTICALS INTERNATIONAL, INC.

Resultados del Ensayo Clínico

Publicaciones en Revistas 148

[Translated article] Pharmacokinetic-guided switching from standard half-life factor VIII to extended half-life pegylated factor VIII in haemophilia A therapy in clinical practice.

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[Translated article] Real-world effectiveness and safety of nivolumab in patients with relapsed or refractory classical Hodgkin lymphoma.

Fernandez, Laura Lorente; (...); Andres, Jose Luis Poveda

Article. 10.1016/j.farma.2024.09.006. 2024

12-Month Effectiveness and Tolerability of Brivaracetam in the Real-World: The International EXPERIENCE Pooled Analysis

Villanueva, Vicente; (...); Steinhoff, Bernhard J.

Meeting Abstract. 10.1212/WNL.0000000000201896. 2023

A brain atlas of axonal and synaptic delays based on modelling of cortico-cortical evoked potentials

Lemarechal, Jean-Didier; (...); David, Olivier

Article. 10.1093/brain/awab362. 2022

A multicriteria decision analysis (MCDA) applied to three long-term prophylactic treatments for hereditary angioedema in Spain

Zozaya, Neboa; (...); Hidalgo-Vega, Alvaro

Article. 10.33393/grhta.2022.2333. 2022

A multi-criteria decision analysis on the value of nintedanib for interstitial lung diseases.

Zozaya, Neboa; (...); Verde, Luis

Article. 10.1017/S0266462322000459. 2022

A phase 2, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of soticlestat as adjunctive therapy in pediatric patients with Dravet syndrome or Lennox-Gastaut syndrome (ELEKTRA).

Hahn, Cecil D.; (...); Dlugos, Dennis

Article. 10.1111/epi.17367. 2022

Academic and employment insertion as a factor related to quality of life in patients with drug-resistant temporal lobe epilepsy.

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Article. 10.33588/rn.7407.2020684. 2022

Analysis of chemical contamination by hazardous drugs with BD HD Check(R) system in a tertiary hospital

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

Article. 10.1177/10781552211038518. 2021

Anti-GAD65-related epilepsy and its clinical spectrum

Marin Gracia, M.; (...); Villanueva, V.

Meeting Abstract. 2024

Antireconverin antibodies in ocular chronic graft versus host disease: A new cause of nonparaneoplasic autoimmune retinopathy

Aguilar Gonzalez, Marina; (...); Espana Gregori, Enrique

Article. 10.1177/11206721221123779. 2022

Assessing the value of moderate-to-severe atopic dermatitis treatment using multi-criteria decision analysis (MCDA).

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Letter. 10.1111/jdv.19432. 2023

Bioavailability of once-daily tacrolimus formulations used in clinical practice in the management of De Novo kidney transplant recipients: the better study.

Fernandez Rivera C; (...); Hernandez D

Article. 10.1111/ctr.14550. 2022

Biochemical-molecular-genetic biomarkers in the tear film, aqueous humor, and blood of primary open-angle glaucoma patients.

Pinazo-Durán MD; (...); García-Feijoo J

Article. 10.3389/fmed.2023.1157773. 2023

BRIVA-ONE study: 12-month outcomes of brivaracetam monotherapy in clinical practice

Villanueva, V.; (...); Sansa, G.

Meeting Abstract. 2024

BRIVA-ONE study: 12-month outcomes of brivaracetam monotherapy in clinical practice.

Villanueva V; (...); Serratosa JM

Article. 10.1002/epi4.13078. 2024

Brivaracetam effectiveness and tolerability in older and younger adults with epilepsy: EXPERIENCE, a pooled analysis of international data from retrospective studies.

Faught, Edward; (...); Villanueva, Vicente

Article. 10.1016/j.yebeh.2024.109922. 2024

Budget impact analysis of the XEN®63 for the treatment of primary openangle glaucoma in Spain.

Vila Arteaga, J; (...); Uria Mundo, E

Article. 10.1016/j.oftale.2022.11.002. 2022

Candidate Selection for Implantation: Noninvasive Predictors of Seizure Onset Zone Focality and Surgical Outcome in People with Drug-Resistant Epilepsy Evaluated by Intracranial Video-EEG Monitoring-A Retrospective Cohort Study

Jannone-Pedro, Nicolas; (...); Villanueva, Vicente

Article. 10.1155/2023/3455061. 2023

Cannabidiol for the treatment of Lennox-Gastaut syndrome and Dravet syndrome: experts' recommendations for its use in clinical practice in Spain

Garcia-Penas, JJ; (...); Villanueva-Haba, V

Article. 10.33588/rn.73S01.2021250. 2021

CLINICAL AND ECONOMIC CONSEQUENCES OF EPILEPSY TREATMENT ACROSS INCREMENTAL TREATMENT LINES IN SPAIN: A REAL LIFE DATABASE ANALYSIS

Toledano, R.; (...); Hernandez, I

Meeting Abstract. 2023

Clinical and economic implications of epilepsy management across treatment lines in Spain: a real-life database analysis.

Toledano R; (...); Pérez-Domper P

Article. 10.1007/s00415-023-11958-x. 2023

Clinical characteristics of patients achieving seizure freedom in a phase 2 trial evaluating adjunctive cenobamate

Brandt, C.; (...); Steinhoff, B.

Meeting Abstract. 2022

Clinical utility of Epitrack for differentiating profiles and patterns of post-surgical change in memory and quality of life in patients with drug-resistant epilepsy.

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Article. 10.1080/23279095.2022.2036990. 2022

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

Cognitive phenotypes in patients with drug-resistant temporal lobe epilepsy: Relationships with cortisol and affectivity.

Cano-Lopez, Irene; (...); Gonzalez-Bono, Esperanza

Article. 10.1080/13854046.2024.2375605. 2024

Comparison of different agents and doses of anti-vascular endothelial growth factors (aflibercept, bevacizumab, conbercept, ranibizumab) versus laser for retinopathy of prematurity: A network meta-analysis.

Ortiz-Seller, Amparo; (...); Ortiz, Jose L.

Article. 10.1016/j.survophthal.2024.02.005. 2024

Consensus recommendations for the improvement of inter- and intra-centre care coordination in the management of hemophilia.

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Article. 10.1016/j.farma.2023.01.003. 2023

Consensus recommendations for the improvement of inter- and intra-centre care coordination in the management of hemophilia.

Montoro-Ronsano, Jose Bruno; (...); Soto-Ortega, Inmaculada

Article. 10.1016/j.farma.2023.04.002. 2023

Childhood-Onset Non-Infectious Uveitis in the "Biologic Era". Results From Spanish Multicenter Multidisciplinary Real-World Clinical Settings.

Mesa-Del-Castillo P; (...); Sánchez Sevila JL

Article. 10.1080/09273948.2024.2336609. 2024

Design and rationale for a real-world prospective, multicenter registry of myocardial revascularization failure and secondary revascularization: The REVASEC study.

Salinas P; (...); Escaned J

Article. 10.1016/j.carrev.2021.11.015. 2021

Design of two parallel randomized, double-blind, placebo-controlled phase 3 studies to evaluate the safety and efficacy of XEN1101 as adjunctive therapy in the treatment of focal onset epilepsy

Perucca, E.; (...); Beatch, G. N.

Meeting Abstract. 2023

Determination of the economically justifiable price of cenobamate in the treatment of focal-onset seizures in adult patients with drug-resistant epilepsy in Spain.

Angel Calleja, Miguel; (...); Gil, Alicia

Article. 10.1080/14737167.2022.2107507. 2022

Determining value in the treatment of activated PI3Kdelta syndrome in Spain: a multicriteria decision analysis from the perspective of key stakeholders.

Abad, Maria Reyes; (...); Gil, Alicia

Article. 10.33393/grhta.2024.3041. 2024

Determining what represents value in the treatment of prurigo nodularis and its key unmet needs in Spain through Multi-Criteria Decision Analysis

Silvestre, Juan Francisco; (...); Serra-Baldrich, Esther

Article. 10.1002/jvc2.275. 2024

Development and validation of the Epilepsy Perceived Stress Inventory for Adults (EPSI-A): A pilot study

Catalan-Aguilar, Judit; (...); Gonzalez-Bono, Esperanza

Article. 10.1016/j.yebeh.2024.110142. 2024

Effect of concomitant medications on adverse event frequency, severity, and resolution in a cenobamate open-label trial

Steinhoff, B.; (...); Villanueva, V.

Meeting Abstract. 2024

Effectiveness and safety of perampanel in elderly epilepsy patients (aged >= 65 years) treated in everyday clinical practice

McMurray, Rob; (...); Villanueva, Vicente

Meeting Abstract. 2021

Effectiveness and Tolerability of 12-Month Brivaracetam in the Real World: EXPERIENCE, an International Pooled Analysis of Individual Patient Records.

Villanueva V; (...); Steinhoff BJ

Article. 10.1007/s40263-023-01033-4. 2023

Effectiveness and tolerability of brivaracetam in patients with epilepsy stratified by comorbidities and etiology in the real world: 12-month subgroup data from the international EXPERIENCE pooled analysis.

Szaflarski, Jerzy P; (...); Villanueva, Vicente

Article. 10.1007/s00415-024-12253-z. 2024

Effectiveness, safety and tolerability of perampanel by age group when used to treat people with focal and generalized epilepsy in clinical practice: The PERMIT Extension study.

Wheless J; (...); Villanueva V

Article. 10.1016/j.yebeh.2023.109369. 2023

Effectiveness, safety and tolerability of perampanel in adolescents with focal and generalised seizures: evidence from clinical practice

Gil, Francisco; (...); Villanueva, Vicente

Meeting Abstract. 2021

Healthcare Resource Utilization among Patients between 60-75 Years with Secondary Acute Myeloid Leukemia Receiving Intensive Chemotherapy Induction: A Spanish Retrospective Observational Study

Solana-Altabella, Antonio; (...); Martinez-Cuadron, David

Article. 10.3390/cancers14081921. 2022

Impact of Polytherapy on Memory Functioning in Patients With Drug-Resistant Epilepsy: The Role of Attention and Executive Functions.

Lozano-Garcia, Alejandro; (...); Gonzalez-Bono, Esperanza

Article. 10.1093/arclin/acad086. 2023

Is erenumab an efficient alternative for the prevention of episodic and chronic migraine in Spain? Results of a cost-effectiveness analysis.

Pozo-Rosich P; (...); Irimia P

Article. 10.1186/s10194-024-01747-w. 2024

Isavuconazole Pharmacokinetics in Critically Ill Patients: Relationship with Clinical Effectiveness and Patient Safety.

Martin-Cerezuela, Maria; (...); Ramirez Galleymore, Paula

Article. 10.3390/antibiotics13080706. 2024

La reserva cognitiva como factor modulador del impacto de la cirugía sobre la memoria visual y la denominación en pacientes con epilepsia del lóbulo temporal.

Cano-Lopez, I; (...); Gonzalez-Bono, E

Article. 10.33588/rn.7308.2021109. 2021

Long-Term Efficacy and Safety From an Open-Label Extension of Adjunctive Cenobamate in Patients With Uncontrolled Focal Seizures.

Klein, Pavel; (...); Villanueva, Vicente

Article. 10.1212/WNL.0000000000200792. 2022

Long-term, quality of life in epilepsy inventory-31 (QOLIE-31) improvements in adults with focal onset seizures treated with XEN1101 in an ongoing, open-

Brandt, C.; (...); Beatch, G. N.

Meeting Abstract. 2024

Management of patients with Dravet syndrome in real-world clinical practice across five countries in Europe: Impact of treatment-related burden on health outcomes

Ross, E.; (...); Andrews, J. S.

Meeting Abstract. 2024

Manipulación de fármacos para su administración por gastrostomía endoscópica percutánea en pacientes con esclerosis lateral amiotrófica y nutrición enteral.

Vázquez Polo A; (...); Vázquez Costa JF

Article. 10.20960/nh.03946. 2022

Metabolic Phenotyping in Prostate Cancer Using Multi-Omics Approaches.

Gomez-Cebrian, Nuria; (...); Puchades-Carrasco, Leonor

Article. 10.3390/cancers14030596. 2022

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

Multi-Omic Approaches to Breast Cancer Metabolic Phenotyping: Applications in Diagnosis, Prognosis, and the Development of Novel Treatments

Gomez-Cebrian, N; (...); Pineda-Lucena, A

Review. 10.3390/cancers13184544. 2021

National Survey on the Use of Mobile Applications in Patients with Hemophilia and Other Coagulopathies

Eduardo Megias, Juan; (...); Poveda Andres, Jose Luis

Meeting Abstract. 10.1182/blood-2022-169938. 2022

New challenges of advanced therapies.

Megías-Vericat JE; (...); Poveda Andrés JL

Article. 10.1016/j.farma.2023.11.008. 2024

Number needed to treat and associated cost analysis of cenobamate versus third-generation anti-seizure medications for the treatment of focal-onset seizures in patients with drug-resistant epilepsy in Spain.

Villanueva, Vicente; (...); Gil, Alicia

Article. 10.1016/j.yebeh.2022.109054. 2023

Observational study to evaluate discontinuation of monotherapy with cobicistat-boosted darunavir in patients with human immunodeficiency virus

Solana-Altabella, Antonio; (...); Poveda-Andres, Jose Luis

Article. 10.1097/MD.0000000000032208. 2022

ODs with a positive TPR conclusion, not subject to a conditional approval, and approved without requering a pass would be more likely to be reimbursed in Spain.

Poveda JL; (...); Badia X

Article. 10.1186/s13023-022-02610-4. 2023

Omics-Based Approaches for the Characterization of Pompe Disease Metabolic Phenotypes

Gomez-Cebrian, Nuria; (...); Puchades-Carrasco, Leonor

Review. 10.3390/biology12091159. 2023

OPTIMIZING MANAGEMENT AND OUTCOMES OF ACTIVATED PHOSPHOINOSITIDE 3-KINASE DELTA SYNDROME (APDS) IN SPAIN: BEWAYAPDS PROJECT

Flores-Moreno, S.; (...); Gil, A.

Meeting Abstract. 2024

Oxidative Stress Mediates Epigenetic Modifications and the Expression of miRNAs and Genes Related to Apoptosis in Diabetic Retinopathy Patients

Karam-Palos S; (...); Pinazo-Durán MD

Article. 10.3390/jcm13010074. 2024

Paracetamol vs. Ibuprofen in Preterm Infants With Hemodynamically Significant Patent Ductus Arteriosus: A Non-inferiority Randomized Clinical Trial Protocol (vol 8, 372, 2020)

Garcia-Robles, Ana; (...); Aguar Carrascosa, Marta

Correction. 10.3389/fped.2021.834454. 2022

Patient and health practitioner perceptions about the role of hospital pharmacists along the care continuum: the Fharmaconectados Project

Morillo-Verdugo, R; (...); Diaz-Olmo, J

Article. 10.7399/fh.11719. 2021

Patient and health practitioner perceptions about the role of hospital pharmacists along the care continuum: the Fharmaconectados Project.

Morillo-Verdugo R; (...); Díaz-Olmo J

Article. 2021

Patient profile, management, and quality of life associated with Dravet syndrome: a cross-sectional, multicentre study of 80 patients in Spain.

Gil-Nagel, Antonio, Sanchez-Carpintero, Rocio, Villanueva, Vicente

Article. 10.1038/s41598-023-30273-z. 2023

Perampanel as Early Add on Therapy for Epilepsy Patients with Focal -Onset an Generalized-Onset Seizures Treated in Clinical Practice(p1-1.Virtua)

Santamarina, Estevo; (...); Villanueva, Vicente

Meeting Abstract. 2022

Perampanel as Early Add on Therapy for Epilepsy Patients with Focal -Onset and Generalized-Onset Seizures Treated in Clinical Practice(p1-1.Virtual)

Santamarina, Estevo; (...); Villanueva, Vicente

Meeting Abstract. 2022

Perampanel as early add-on therapy for epilepsy patients with focal and generalised seizures treated in clinical practice

Santamarina Perez, Estevo; (...); Villanueva, Vicente

Meeting Abstract. 2021

Perampanel for the treatment of Asian people with epilepsy: Real-world evidence from the PERMIT extension study.

Wu, Tony; (...); Villanueva, Vicente

Article. 10.1016/j.jns.2024.123173. 2024

Perampanel for the treatment of epilepsy with genetic aetiology: Real-world evidence from the PERMIT Extension study.

Delanty N; (...); Villanueva V

Article. 10.1016/j.eplepsyres.2024.107339. 2024

Perampanel for the treatment of focal and generalised seizures in patients with epilepsy with tumour aetiology: evidence from clinical practice

Coppola, Antonietta; (...); Villanueva, Vicente

Meeting Abstract. 2021

Perampanel for the treatment of patients with myoclonic seizures in clinical practice: Evidence from the PERMIT study

D'Souza, Wendyl; (...); Villanueva, Vicente

Article. 10.1016/j.seizure.2022.06.008. 2022

Perampanel for the Treatment of People with Idiopathic Generalized Epilepsy in Clinical Practice.

Trinka E; (...); Villanueva V

Article. 10.1111/epi.17631. 2023

Perampanel for treatment of epilepsy with tumour, vascular or traumatic brain injury aetiology: Evidence from the PERMIT extension study

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

Meeting Abstract. 2024

Perampanel for treatment of focal and generalized epilepsy in everyday clinical practice: Evidence from permit extension

Trinka, Eugen; (...); Villanueva, Vicente

Meeting Abstract. 10.1016/j.jns.2023.121561. 2023

Perampanel for Treatment of People with a Range of Epilepsy Aetiologies in Clinical Practice: Evidence from the PERMIT Extension Study.

Strzelczyk, Adam; (...); Villanueva, Vicente

Article. 10.1007/s40120-024-00618-5. 2024

Perampanel in adult epilepsy patients treated in everyday clinical practice: results from an interim pooled analysis of real-world studies

Strzelczyk, Adam; (...); Villanueva, Vicente

Meeting Abstract. 2021

Perampanel Monotherapy for Focal and Generalized Epilepsy in Clinical Practice

Chinvarun, Yotin; (...); Villanueva, Vicente

Article. 10.1155/2023/2852853. 2023

Perampanel monotherapy in epilepsy patients with focal and generalised seizures: real-world experience

Alsaadi, Taoufik; (...); Villanueva, Vicente

Meeting Abstract. 2021

Perampanel outcomes at different stages of treatment in people with focal and generalized epilepsy treated in clinical practice: Evidence from the PERMIT study.

Liguori, Claudio; (...); Villanueva, Vicente

Article. 10.3389/fneur.2023.1120150. 2023

Presurgical Use of Cenobamate for Adult and Pediatric Patients Referred for Epilepsy Surgery: Expert Panel Recommendations.

Laxer KD; (...); Villanueva V

Article. 10.1007/s40120-024-00651-4. 2024

Prognostic value of the 5-SENSE Score to predict focality of the seizure-onset zone as assessed by stereoelectroencephalography: a prospective international multicentre validation study.

Astner-Rohracher, Alexandra; (...); Frauscher, Birgit

Article. 10.1136/bmjno-2024-000765. 2024

Real-world clinical burden of non-seizure symptoms among patients with dravet syndrome or Lennox- Gastaut syndrome in Europe: Results from a global multinational survey

Berthoz, F. Truong; (...); Andrews, J. S.

Meeting Abstract. 2024

Real-World Experience of Perampanel Monotherapy in Epilepsy Patients with Focal-Onset and Generalized-Onset Seizures

Alsaadi, Taoufik; (...); Villanueva, Vicente

Meeting Abstract. 2022

Real-world experience of treating patients aged <12 years with perampanel

Auvin, Stephane; (...); Villanueva, Vicente

Meeting Abstract. 2021

Real-world safety and effectiveness of cenobamate in patients with focal onset seizures: outcomes from an Expanded Access Program.

Villanueva, Vicente; (...); Rodriguez-Uranga, Juan J.

Article. 10.1002/epi4.12757. 2023

Refractory status epilepticus due to vitamin B6 deficit in a Parkinson's disease patient in treatment with levodopa/carbidopa intestinal gel

Baviera-Munoz, R.; (...); Martinez-Torres, I.

Letter. 10.1016/j.nrl.2021.10.002. 2022

Refractory status epilepticus due to vitamin B6 deficit in a Parkinson's disease patient in treatment with levodopa/carbidopa intestinal gel.

Baviera-Muñoz R; (...); Martinez-Torres I

Article. 10.1016/j.nrleng.2021.10.002. 2022

Retinoblastoma and mosaic 13q deletion: a case report

Gargallo P; (...); Canete, A

Article. 10.1186/s40942-021-00321-9. 2021

Retrospective chart review study of use of cannabidiol (CBD) independent of concomitant clobazam use in patients with Lennox-Gastaut syndrome or Dravet syndrome.

Nabbout, Rima; (...); Cross, J. Helen

Article. 10.1016/j.seizure.2023.05.003. 2023

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

SMPTall man lettering application in medication information systems as a quality and safety strategy in hospital organization

Iglesias Gomez, Ruben; (...); Poveda Andres, Jose Luis

Article. 10.1111/jcpt.13703. 2022

Spanish consensus on the management of concomitant antiseizure medications when using cenobamate in adults with drug-resistant focal seizures.

Carreño M; (...); Villanueva V

Article. 10.1002/epi4.12936. 2024

The Charlotte Project: Recommendations for patient-reported outcomes and clinical parameters in Dravet syndrome through a qualitative and Delphi consensus study.

Aledo-Serrano Á; (...); Sánchez-Carpintero R

Article. 10.3389/fneur.2022.975034. 2022

The Global Retinoblastoma Outcome Study: a prospective, cluster-based analysis of 4064 patients from 149 countries

Alia, Donjeta B.; (...); Nyaywa, Mutale

Article. 10.1016/S2214-109X(22)00250-9. 2022

The relationship between memory and quality of life is mediated by trait anxiety in patients with temporal lobe epilepsy.

Cano-Lopez, Irene; (...); Gonzalez-Bono, Esperanza

Article. 10.1007/s11136-022-03306-9. 2022

The significance of very long half-life in the context of antiseizure medication withdrawal during long-term video-EEG monitoring.

Hampel, Kevin Gil; (...); Villanueva, Vicente

Letter. 10.1016/j.seizure.2024.01.006. 2024

The value of the reflective discussion in decision-making using multi-criteria decision analysis (MCDA): an example of determining the value contribution of tabelecleucel for the treatment of the Epstein Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD).

Badia, Xavier; (...); Valles, Joan-Antoni

Article. 10.1186/s13023-024-03324-5. 2024

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

Unravelling the mysteries of sudden unexpected death in epilepsy (vol 34, pg 527, 2019)

Hampel, K. G., Rocamora, R., Quesada, C. M.

Correction. 10.1016/j.nrl.2021.11.004. 2022

Use of Stiripentol in Patients with Dravet Syndrome: Common Practice Among Experts in Spain.

Garcia-Penas, Juan Jose; (...); Sanchez-Carpintero, Rocio

Article. 10.1007/s40120-024-00677-8. 2024

VALUE CRITERIA FOR OUTCOMES BASED MANAGED ENTRY AGREEMENT OF CAR-T IN RELAPSED OR REFRACTORY MULTIPLE MYELOMA (RRMM) THROUGH MCDA

Poveda, J. L.; (...); Lizan, L.

Meeting Abstract. 2023

What do 90-99% responder rates mean in patients treated with cenobamate: results from an open label extension study

Serratosa, J.; (...); Villanueva, V.

Meeting Abstract. 2023

What do 90-99% responder rates mean in patients treated with cenobamate: results from the open label extension (OLE) of study C017?

Serratosa, J. M.; (...); Villanueva, V.

Meeting Abstract. 2023

Which patient related outcome best reflects the willing of a patient to continue with an anti-CGRP monoclonal preventive treatment? A sub-analysis of a prospective study

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Meeting Abstract. 2021