A Phase 3, Open-label Study of Adjunctive Ganaxolone (GNX) Treatment in Children and Adults with Tuberous Sclerosis Complex (TSC)-related Epilepsy(TrustTSC OLE).
Dades bàsiques
- Protocol:
- 1042-TSC-3002
- EURDRACT:
- 2021-003384-10
- NCT:
- Centre:
- HOSPITAL UNIVERSITARI I POLITÈCNIC LA FE
- Any inici:
- 2023
- Any de finalització:
Documents
- No hi ha documents
Participants
Grups d'Investigació
Finançadors - Promotors
Resultats de l'Assaig Clínic
[Translated article] Cybersecurity: a priority for pharmacy services in the age of artificial intelligence
Marin, Cayetano M. Hernandez, Monte-Boquet, Emilio, Andres, Jose Luis Poveda
Editorial Material. 10.1016/j.farma.2024.08.009. 2024
[Translated article] Good humanisation practices in the healthcare of patients with rare diseases in Pharmacy Services
Company Albir MJ, Andrés JLP, Solsona MDE
Article. 10.1016/j.farma.2023.10.004. 2024
[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
[Translated article] New challenges in advanced therapies.
Megías-Vericat JE; (...); Poveda Andrés JL
Article. 10.1016/j.farma.2024.05.001. 2024
[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 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
Anti-GAD65-related epilepsy and its clinical spectrum
Marin Gracia, M.; (...); Villanueva, V.
Meeting Abstract. 2024
Assessing the value of moderate-to-severe atopic dermatitis treatment using multi-criteria decision analysis (MCDA).
Pereyra-Rodríguez JJ; (...); Ortiz de Frutos FJ
Letter. 10.1111/jdv.19432. 2023
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
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
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
Cenobamate in real-life setting: Final outcomes of an expanded access program
Villanueva-Haba, V.; (...); Massot-Tarrus, A.
Meeting Abstract. 2023
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
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
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
COST-EFFECTIVENESS ANALYSIS OF DIFELIKEFALIN FOR THE TREATMENT OF CHRONIC KIDNEY DISEASE ASSOCIATED-PRURITUS IN SPAIN
Sanchez-Alvarez, Emilio E.; (...); Hernaez Colque, M.
Meeting Abstract. 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
Cybersecurity, a priority for pharmacy services in the age of artificial intelligence.
Hernández Marín CM, Monte-Boquet E, Poveda Andrés JL
Editorial Material. 10.1016/j.farma.2024.08.001. 2024
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
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 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
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
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
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
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
Efficacy of stiripentol in the management of status epilepticus: A systematic review
Auvin, S.; (...); Trinka, E.
Meeting Abstract. 2024
Genetic Variants Associated with Biological Treatment Response in Inflammatory Bowel Disease: A Systematic Review.
Plaza J; (...); Moret-Tatay I
Article. 10.3390/ijms25073717. 2024
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
Incidence and Risk Factors for Development of Cardiac Toxicity in Adult Patients with Newly Diagnosed Acute Myeloid Leukemia
Boluda, Blanca; (...); Montesinos, Pau
Article. 10.3390/cancers15082267. 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
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
New challenges of advanced therapies.
Megías-Vericat JE; (...); Poveda Andrés JL
Article. 10.1016/j.farma.2023.11.008. 2024
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
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 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
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
Presence of good humanization practices in the healthcare of patients with rare diseases in Pharmacy Services
Company Albir MJ, Poveda Andrés JL, Edo Solsona MD
Article. 10.1016/j.farma.2023.06.0131130. 2024
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
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
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
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
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
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
Stereoencephalography-guided thermocoagulation: Experience in our centre
De Castro Garcia, A. Celdran; (...); Villanueva, V.
Meeting Abstract. 2024
Stress phenotypes in epilepsy: impact on cognitive functioning and quality of life.
Catalán-Aguilar J; (...); Cano-López I
Article. 10.3389/fpsyg.2023.1100101. 2023
Sustained =90% response and seizure freedom in patients with focal-onset seizures treated with cenobamate
Alvarez-Baron, E., Thangavelu, K., Villanueva, V.
Meeting Abstract. 2023
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
Therapeutic strategies during cenobamate treatment initiation: Delphi panel recommendations
Steinhoff, Bernhard J.; (...); Villanueva, Vicente
Review. 10.1177/17562864241256733. 2024
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
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