ESTUDIO EN FASE IIB, ALEATORIZADO, CON DOBLE ENMASCARAMIENTO, COMPARATIVO CON PLACEBO Y MULTICÉNTRICO, PARA EVALUAR LA EFICACIA Y LA SEGURIDAD DE PRASINEZUMAB INTRAVENOSO EN PARTICIPANTES CON ENFERMEDAD DE PARKINSON INCIPIENTE).

Dades bàsiques

Protocol:
BN42358
EURDRACT:
2020-004997-23
NCT:
Centre:
HOSPITAL UNIVERSITARI I POLITÈCNIC LA FE
Any inici:
2021
Any de finalització:
2024
ENSAYO CLÍNICO

Documents

  • No hi ha documents

Participants

Grups d'Investigació

Finançadors - Promotors

F. HOFFMANN-LA ROCHE LTD

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

  • Open Access.

[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

  • 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 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

  • Open Access.

A 3.9-Mb Deletion on 2p11.2 Comprising the REEP1 Gene Causes Early-Onset Atypical Parkinsonism.

Baviera-Muñoz R; (...); Espinós C

Article. 10.1212/NXG.0000000000000642. 2021

  • Open Access.

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

  • Open Access.

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

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

Article. 10.1017/S0266462322000459. 2022

  • Open Access.

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


Artificial intelligence for identification of candidates for device-aided therapy in Parkinson's disease: DELIST-PD study.

Freire-Alvarez, Eric; (...); Escamilla-Sevilla, Francisco

Article. 10.1016/j.compbiomed.2024.109504. 2024

  • Open Access.

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

  • Open Access.

Baricitinib against severe COVID-19: effectiveness and safety in hospitalised pretreated patients.

Iglesias Gómez R; (...); Poveda Andrés JL

Article. 10.1136/ejhpharm-2021-002741. 2021

  • Open Access.

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

  • Open Access.

Clinical and genetic characteristics of 21 Spanish patients with biallelic pathogenic SPG7 mutations.

Baviera-Muñoz R; (...); Espinós C

Article. 10.1016/j.jns.2021.118062. 2021


Clinical benefits of a Bayesian model for plasma-derived factor VIII/VWF after one year of pharmacokinetic-guided prophylaxis in severe/moderate hemophilia A patients

Megias-Vericat, JE; (...); Poveda, JL

Article. 10.1016/j.thromres.2021.07.009. 2021


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

  • Open Access.

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


Costs of the management of hemophilia A with inhibitors in Spain

Bonanad, S; (...); Gonzalez-Dominguez, A

Article. 10.33393/grhta.2021.2234. 2021

  • Open Access.

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

  • Open Access.

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


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

  • Open Access.

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

  • Open Access.

Diagnostic Efficacy of Genetic Studies in a Series of Hereditary Cerebellar Ataxias in Eastern Spain.

Baviera-Munoz, Raquel; (...); Aller, Elena

Article. 10.1212/NXG.0000000000200038. 2022

  • Open Access.

Efectos adversos y complicaciones de la infusión intestinal continua de levodopa-carbidopa en una cohorte de pacientes con enfermedad de Parkinson de un hospital terciario.

Campins-Romeu, Marina; (...); Martinez-Torres, Irene

Article. 10.33588/rn.7405.2021482. 2022


Effectiveness and safety of levodopa-entacapone-carbidopa infusion in Parkinson disease: A real-world data study.

Santos-García D; (...); Mata M

Article. 10.1111/ene.16535. 2024

  • Open Access.

Effectiveness of Caplacizumab Nanobody in Acquired Thrombotic Thrombocytopenic Purpura Refractory to Conventional Treatment

Palanques-Pastor T; (...); Poveda Andrés JL

Article. 10.1159/000517813. 2021


Erenumab vs galcanezumab in a very difficult-to-treat migraine population. Efficacy and safety

Samuel, DI; (...); Jose, NMM

Meeting Abstract. 2021


Erenumab vs galcanezumab in a very difficult-to-treat migraine population. Efficacy and safety

Samuel, DI; (...); Jose, NMM

Meeting Abstract. 2021


Estimulación cerebral profunda combinada del núcleo subtalámico y el globo pálido interno en la enfermedad de Parkinson.

Campins-Romeu M; (...); Martínez-Torres I

Case Reports. 10.33588/rn.7703.2022250. 2023

  • Open Access.

Fetal exposure to tofacitinib during the first trimester: A healthy newborn case report

Fernandez-Sanchez, M; (...); Poveda-Andres, JL

Article. 10.1002/bdr2.1942. 2021


Gait Function after High-Intensity Focused Ultrasound Thalamotomy for Essential Tremor: Searching for Technique Optimization.

Sastre-Bataller, Isabel; (...); Martinez-Torres, Irene

Article. 10.1159/000527374. 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

  • Open Access.

Guide to Good Humanization Practices in Patients with Rare Diseases. who vadis

Poveda Andres, Jose Luis

Editorial Material. 2022


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

  • Open Access.

Health-Related Quality of Life in Patients Living with Wilson Disease in Spain: A Cross-Sectional Observational Study.

Marino, Zoe; (...); Anguera, Anna

Article. 10.3390/jcm12144823. 2023

  • Open Access.

Hereditary Spastic Paraplegia 7 Presenting as Multifocal Dystonia with Prominent Cranio-Cervical Involvement

Campins-Romeu, M; (...); Martinez-Torres, I

Letter. 10.1002/mdc3.13257. 2021

  • Open Access.

High incidence of pulmonary thromboembolism in hospitalized SARS-CoV-2 infected patients despite thrombo-prophylaxis.

El-Qutob D; (...); Carrera-Hueso FJ

Article. 10.1016/j.hrtlng.2022.02.003. 2022

  • Open Access.

Hospital pharmacy initiatives for improving the management of patients with congenital coagulopathies

Bruno Montoro-Ronsano, Jose; (...); Alberto Vella, Vincenzo

Article. 10.7399/fh.11729. 2022


Hospitalization budget impact during the COVID-19 pandemic in Spain.

Carrera-Hueso, F. J.; (...); Crespo-Palomo, C.

Article. 10.1186/s13561-021-00340-0. 2021

  • Open Access.

How can artificial intelligence optimize value-based contracting?

Poveda, Jose Luis; (...); Medrano, Ignacio H.

Letter. 10.1186/s40545-022-00475-3. 2022

  • Open Access.

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

  • Open Access.

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

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

Article. 10.3390/antibiotics13080706. 2024

  • Open Access.

Management of flexible cavovarus foot in patients with Charcot-Marie-Tooth disease: midterm results.

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

Article. 2021

  • Open Access.

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

  • Open Access.

Matching-Adjusted Indirect Comparison of Efficacy and Consumption of rVIII-SingleChain Versus Two Recombinant FVIII Products Used for Prophylactic Treatment of Adults/Adolescents with Severe Haemophilia A

Bonanad, S; (...); Santos, S

Article. 10.1007/s12325-021-01853-0. 2021

  • Open Access.

Metabolic Phenotyping in Prostate Cancer Using Multi-Omics Approaches.

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

Article. 10.3390/cancers14030596. 2022

  • Open Access.

MNCD: A New Tool for Classifying Parkinson's Disease in Daily Clinical Practice.

Santos García D; (...); Ignacio, AS

Article. 10.3390/diagnostics12010055. 2021

  • Open Access.

MRgFUS subthalamotomy in Parkinson's disease: an approach aimed at minimizing Lesion Volume

Campins-Romeu, Marina; (...); Martinez-Torres, Irene

Article. 10.1038/s41531-024-00843-7. 2024

  • Open Access.

MRgFUS subthalamotomy in Parkinson's disease: an approach aimed at minimizing Lesion Volume (vol 10, 230, 2024)

Campins-Romeu, Marina; (...); Martinez-Torres, Irene

Correction. 10.1038/s41531-025-00871-x. 2025

  • Open Access.

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

  • Open Access.

Mutations, genes and phenotypes related to movement disorders: a never-ending list

Martinez-Rubio, Dolores; (...); Espinos, Carmen

Meeting Abstract. 2022


National Survey of the SEFH-2019: portfolio of services, healthcare activity, teaching and research in Hospital Pharmacy Services in Spain (vol 45, pg 32, 2021)

Perez-Encinas, Montserrat; (...); Angel Calleja-Hernandez, Miguel

Correction. 10.7399/fh.11740. 2021

  • Open Access.

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

  • Open Access.

New challenges of advanced therapies.

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

Article. 10.1016/j.farma.2023.11.008. 2024

  • Open Access.

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

  • Open Access.

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

  • Open Access.

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

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

Review. 10.3390/biology12091159. 2023

  • Open Access.

Opicapona para el tratamiento de la enfermedad de Parkinson: datos de vida real en España.

López-Ariztegui N; (...); Vinagre-Aragón A

Article. 10.33588/rn.73s02.2021461. 2021

  • Open Access.

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

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

Meeting Abstract. 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

  • Open Access.

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

  • 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.

Pharmacometabolomics by NMR in Oncology: A Systematic Review.

Gómez-Cebrián N; (...); Pineda-Lucena A

Article. 10.3390/ph14101015. 2021

  • Open Access.

Pharmacotherapeutic management of advanced therapy medicinal products

Luis Poveda-Andres, Jose; (...); Valero-Garcia, Silvia

Article. 10.7399/fh.13036. 2022


Preparation and administration of insulin infusions in neonatology: A national survey.

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

Article. 10.1016/j.anpede.2020.06.015. 2021

  • Open Access.

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

  • Open Access.

Profile of plasma microRNAs as a potential biomarker of Wilson's disease.

Sanchez-Monteagudo, Ana; (...); Espinos, Carmen

Article. 10.1007/s00535-024-02135-6. 2024

  • Open Access.

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

  • Open Access.

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

  • Open Access.

Smoking is associated with age at disease onset in Parkinson's disease.

Rosas I; (...); Bandrés-Ciga S

Article. 10.1016/j.parkreldis.2022.03.005. 2022

  • Open Access.

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

  • Open Access.

Spinocerebellar Ataxia 36 is a Frequent Cause of Hereditary Ataxia in Eastern Spain

Baviera-Munoz, Raquel; (...); Bataller, Luis

Article. 10.1002/mdc3.13740. 2023

  • Open Access.

Staging Parkinson's Disease According to the MNCD (Motor/Non-motor/Cognition/Dependency) Classification Correlates with Disease Severity and Quality of Life.

Santos-Garcia, Diego; (...); Mir, Pablo

Article. 10.3233/JPD-225073. 2023

  • Open Access.

STUB1 Mutations as Possible Genetic Modifiers in Spinocerebellar Ataxia Type 8.

Baviera-Munoz, Raquel; (...); Aller, Elena

Article. 10.1002/mds.29910. 2024

  • Open Access.

Systematic Review of Pharmacogenetics of ABC and SLC Transporter Genes in Acute Myeloid Leukemia

Megías-Vericat JE; (...); Montesinos P

Review. 10.3390/pharmaceutics14040878. 2022

  • Open Access.

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

  • Open Access.

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

  • 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 failure with anti-CGRP therapy: should we discontinue the treatment or switch it?

Castellanos, CN; (...); Insa, SD

Meeting Abstract. 2021


Treatment failure with anti-CGRP therapy: should we discontinue the treatment or switch it?

Castellanos, CN; (...); Insa, SD

Meeting Abstract. 2021


Unilateral MRIgFUS thalamotomy: Long-term follow-up in fragile X-associated tremor/ataxia syndrome

Campins-Romeu, M.; (...); Sastre-Bataller, I.

Letter. 10.1016/j.nrl.2023.11.002. 2024

  • Open Access.

Unilateral MRIgFUS thalamotomy: Long-term follow-up in fragile X-associated tremor/ataxia syndrome.

Campins-Romeu M; (...); Sastre-Bataller I

Case Reports. 10.1016/j.nrleng.2024.09.004. 2024

  • Open Access.

Use of the MNCD Classification to Monitor Clinical Stage and Response to Levodopa-Entacapone-Carbidopa Intestinal Gel Infusion in Advanced Parkinson's Disease

Santos-Garcia, Diego; (...); Alvarez-Santullano, Marina Mata

Article. 10.3390/brainsci14121244. 2024

  • Open Access.

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


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

Castellanos, CN; (...); Insa, SD

Meeting Abstract. 2021


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