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- Estudio intervencionista, aleatorizado, doble ciego, de grupos paralelos y controlado con placebo, de tratamiento con eptinezumab añadido a una breve intervención educativa para el tratamiento preventivo de las migrañas en pacientes con un doble diagnóstico de migraña y cefalea por abuso de medicamentos.
Estudio intervencionista, aleatorizado, doble ciego, de grupos paralelos y controlado con placebo, de tratamiento con eptinezumab añadido a una breve intervención educativa para el tratamiento preventivo de las migrañas en pacientes con un doble diagnóstico de migraña y cefalea por abuso de medicamentos.
Datos básicos
- Protocolo:
- 20007A
- EUDRACT:
- 2021-003049-40
- NCT:
- Centro:
- HOSPITAL UNIVERSITARI I POLITÈCNIC LA FE
- Año de incio:
- 2022
- Año de finalización:
Objetivos del proyecto
Objetivo Principal: La cefalea por uso excesivo de medicamentos (CAM) es un tipo de dolor de cabeza causado por el uso excesivo de medicamentos para el dolor de cabeza o para la migraña de manera aguda (medicamentos que se usan para tratar el dolor de cabeza o la migraña una vez que comienza). El tratamiento de la CAM generalmente implica reducir la dosis o suspender los medicamentos que se toman de manera aguda. Eptinezumab es un medicamento utilizado para el tratamiento preventivo de la migraña en adultos. Los principales objetivos de este ensayo son evaluar si eptinezumab ayuda a reducir el número de días con migraña, el número de días con cefalea, y el uso de medicación de manera aguda en adultos que tengan migraña y CAM. Objetivos Secundarios: -Evaluar la eficacia de eptinezumab como complemento de una IB en la calidad de vida relacionada con la salud y la productividad laboral -Evaluar la eficacia de eptinezumab durante el período de extensión abierto de 12 semanas
Documentos
- No hay documentos
Participantes
Grupos
Financiadores - Promotores
Resultados del Ensayo Clínico
[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] 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
A multi-criteria decision analysis on the value of nintedanib for interstitial lung diseases.
Zozaya, Neboa; (...); Verde, Luis
Article. 10.1017/S0266462322000459. 2022
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
Burden of Episodic and Chronic Migraine in Patients Who Had Failed Multiple Preventive Treatments From France, Spain, and the United Kingdom
Diaz-Insa, Samuel; (...); Goadsby, Peter J.
Article. 10.1155/ane/4714514. 2024
Cluster headache. Are there differences by gender?
Olivier, M. A.; (...); Diaz Insa, S.
Meeting Abstract. 2024
Consensus recommendations for the improvement of inter- and intra-centre care coordination in the management of hemophilia.
Montoro-Ronsano JB; (...); Soto-Ortega I
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
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
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
Characterisation of the management of patients with migraine in the primary care setting in Spain. Analysis of the results of the European My-LIFE anamnesis project
Diaz-Insa, S.; (...); Guerrero, A. L.
Article. 10.1016/j.nrl.2021.10.012. 2023
Characterisation of the management of patients with migraine in the primary care setting in Spain. Analysis of the results of the European My-LIFE anamnesis project.
Diaz-Insa, S; (...); Guerrero, A L
Article. 10.1016/j.nrleng.2021.10.009. 2023
Depression in Major Neurodegenerative Diseases and Strokes: A Critical Review of Similarities and Differences among Neurological Disorders.
Pagonabarraga, Javier; (...); Manzano, Sagrario
Article. 10.3390/brainsci13020318. 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
Diagnosis and treatment of disorders of intracranial pressure: consensus statement of the Spanish Society of Neurology's Headache Study Group
Garcia-Ulla, J.; (...); Irimiao, P.
Article. 10.1016/j.nrl.2023.06.003. 2025
Diagnosis and treatment of disorders of intracranial pressure: consensus statement of the Spanish Society of Neurology's Headache Study Group.
Garcia-Ull, J; (...); Irimia, P
Practice Guideline. 10.1016/j.nrleng.2024.02.009. 2024
Early Alzheimer's Disease Screening Approach Using Plasma Biomarkers
Alvarez-Sanchez, Lourdes; (...); Chafer-Pericas, Consuelo
Article. 10.3390/ijms241814151. 2023
Effectiveness and safety of anti-CGRP monoclonal antibodies in patients over 65 years: a real-life multicentre analysis of 162 patients.
Muñoz-Vendrell A; (...); Huerta-Villanueva M
Article. 10.1186/s10194-023-01585-2. 2023
Genetic Variants Associated with Biological Treatment Response in Inflammatory Bowel Disease: A Systematic Review.
Plaza J; (...); Moret-Tatay I
Article. 10.3390/ijms25073717. 2024
How can artificial intelligence optimize value-based contracting?
Poveda, Jose Luis; (...); Medrano, Ignacio H.
Letter. 10.1186/s40545-022-00475-3. 2022
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
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
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
Nueva era terapéutica para el ataque de migraña con los recientemente aprobados anticuerpos monoclonales, ditanes y gepantes.
Mínguez-Olaondo A; (...); Díaz-Insa S
Article. 10.33588/rn.7802.2023176. 2024
Observational Retrospective Study in Patients Treated with Galcanezumab as Preventive Treatment for Migraine: The ORYGAM Study.
Díaz Insa S; (...); Núñez M
Article. 10.1007/s40122-024-00586-6. 2024
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
Onabotulinum Toxin A (OnA) as a preventive treatment for non-migraine headaches: a retrospective analysis
Nieves Castellanos, C.; (...); Diaz Insa, S.
Meeting Abstract. 2024
OPTIMIZING MANAGEMENT AND OUTCOMES OF ACTIVATED PHOSPHOINOSITIDE 3-KINASE DELTA SYNDROME (APDS) IN SPAIN: BEWAYAPDS PROJECT
Flores-Moreno, S.; (...); Gil, A.
Meeting Abstract. 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
Predictors of =50% and =75% response to anti-CGRP monoclonal antibodies for migraine prevention in real life: results from a european multicenter observational study including 5818 patients
Caronna, E.; (...); Pozo-Rosich, P.
Meeting Abstract. 2024
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
Psychological intervention in refractory chronic migraine patients
Zambrano Camina, M.; (...); Diaz Insa, S.
Meeting Abstract. 2024
Redefining migraine prevention: early treatment with anti-CGRP monoclonal antibodies enhances response in the real world.
Caronna E; (...); Pozo-Rosich P
Article. 10.1136/jnnp-2023-333295. 2024
The association of salivary caffeine levels with serum concentrations in premature infants with apnea of prematurity
Garcia-Robles, Ana; (...); Saenz Gonzalez, Pilar
Article. 10.1007/s00431-022-04628-z. 2022
The contribution of fenfluramine to the treatment of Dravet syndrome in Spain through Multi-Criteria Decision Analysis.
Gil-Nagel A; (...); Gil A
Article. 10.1016/j.yebeh.2022.108711. 2022
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
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
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