Estudio de fase III, multicéntrico, aleatorizado, doble ciego y controlado con placebo para evaluar la seguridad, la tolerabilidad y la eficacia de XEN1101 como tratamiento complementario en las crisis convulsivas de inicio focal.

Dades bàsiques

Protocol:
XPF-010-301
EURDRACT:
2022-502000-73-00
NCT:
Centre:
HOSPITAL UNIVERSITARI I POLITÈCNIC LA FE
Any inici:
2023
Any de finalització:
ENSAYO CLÍNICO Finan. Competitiva Privada

Documents

  • No hi ha documents

Participants

Grups d'Investigació

Finançadors - Promotors

XENON PHARMACEUTICALS INC.

Resultats de l'Assaig Clínic


[Translated article] Knowledge of biological therapy in patients with immune-mediated diseases. BIOINFO study.

Segui-Solanes, Carlos; (...); Borras-Blasco, Joaquin

Article. 10.1016/j.farma.2024.08.002. 2024

  • Open Access.

[Translated article] New challenges in advanced therapies.

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

Article. 10.1016/j.farma.2024.05.001. 2024

  • Open Access.

[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.

Chovi-Trull, Maria; (...); Andres, Jose Luis Poveda

Article. 10.1016/j.farma.2024.12.007. 2025


[Translated aticle] Topical and Oral Roflumilast in Dermatology: A Narrative Review.

Mansilla-Polo M, Gimeno E, Morgado-Carrasco D

Article. 10.1016/j.ad.2024.01.009. 2024

  • Open Access.

Anti-GAD65-related epilepsy and its clinical spectrum

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

Meeting Abstract. 2024


Benefits of physical activity self-monitoring in patients with haemophilia: a prospective study with one-year follow-up.

Pérez-Alenda S; (...); Núñez-Cortés R

Article. 10.1111/hae.14988. 2024

  • Open Access.

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

  • Open Access.

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

  • Open Access.

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

  • Open Access.

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

  • Open Access.

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


Cost-effectiveness and cost-utility analysis of haemate-P versus other von willebrand disease treatments in Spain.

Megias-Vericat, Juan E; (...); Yan, Songkai

Article. 10.1080/13696998.2025.2474886. 2025


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


Development and testing of a mobile app for systematic collection of patient-reported outcomes (PROs) in patients with hemophilia.

Megias-Vericat, J E; (...); Poveda Andres, J L

Letter. 10.1016/j.thromres.2024.109122. 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

  • Open Access.

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 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

  • Open Access.

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

  • Open Access.

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

  • Open Access.

Efficacy and safety of stiripentol in the prevention and cessation of status epilepticus: A systematic review.

Specchio N; (...); Trinka E

Article. 10.1002/epi4.13036. 2024

  • Open Access.

Efficacy of add-on Cenobamate treatment in refractory epilepsy due to Rasmussen's encephalitis.

Schulze-Bonhage A; (...); Villanueva V

Article. 10.1002/epi4.13060. 2024

  • Open Access.

Efficacy of stiripentol in the management of status epilepticus: A systematic review

Auvin, S.; (...); Trinka, E.

Meeting Abstract. 2024


Feasibility and outcomes after dose reduction of immunochemotherapy in young adults with Burkitt lymphoma and leukemia: results of the BURKIMAB14 trial.

Ribera JM; (...); Sancho JM

Article. 10.3324/haematol.2023.283342. 2024

  • Open Access.

Impact of antiseizure medication with a very long half-life on long term video-EEG monitoring in focal epilepsy.

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

Article. 10.1016/j.seizure.2023.12.010. 2023


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


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


Mental, emotional and social dimensions of quality of life and their relationship with physical and functional status in adults with haemophilia.

Rodríguez MA; (...); Chimeno-Hernández A

Article. 10.1016/j.thromres.2024.109181. 2024

  • Open Access.

New challenges of advanced therapies.

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

Article. 10.1016/j.farma.2023.11.008. 2024

  • Open Access.

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

  • Open Access.

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

  • Open Access.

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

  • Open Access.

Pharmacogenetics in Response to Biological Agents in Inflammatory Bowel Disease: A Systematic Review.

Ballesta-Lopez, Octavio; (...); Poveda-Andres, Jose Luis

Article. 10.3390/ijms26041760. 2025

  • Open Access.

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

  • Open Access.

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

  • Open Access.

Prospective study of cenobamate on cognition, affectivity and quality of life in focal epilepsy.

Catalan-Aguilar, Judit; (...); Villanueva, Vicente

Article. 10.1002/epi4.12857. 2023

  • Open Access.

Real-life evidence about the use of intravenous brivaracetam in urgent seizures: The BRIV-IV study.

Villanueva V; (...); Escalza I

Article. 10.1016/j.yebeh.2023.109384. 2023


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


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

  • Open Access.

Stereoencephalography-guided thermocoagulation: Experience in our centre

De Castro Garcia, A. Celdran; (...); Villanueva, V.

Meeting Abstract. 2024


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


Therapeutic strategies during cenobamate treatment initiation: Delphi panel recommendations

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

Review. 10.1177/17562864241256733. 2024

  • Open Access.

Toxic-metabolic encephalopathy induced by metronidazole and disulfiram: classics never die.

Chovi-Trull, Maria; (...); Poveda-Andres, Jose Luis

Article. 10.1136/ejhpharm-2024-004184. 2024


Treatment patterns and disease burden among patients with Lennox- Gastaut syndrome in Europe: A real-world survey

Benitez, A.; (...); Andrews, J. S.

Meeting Abstract. 2024


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

  • Open Access.

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


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