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  3. ESTUDIO CLÍNICO DE FASE III, ALEATORIZADO, MULTICÉNTRICO, DOBLE CIEGO Y CONTROLADO CON PLACEBO PARA EVALUAR LA EFICACIA Y LA SEGURIDAD DE RO7234292 (RG6042) ADMINISTRADO POR VÍA INTRATECAL EN PACIENTES CON ENFERMEDAD DE HUNTINGTON MANIFIESTA.

ESTUDIO CLÍNICO DE FASE III, ALEATORIZADO, MULTICÉNTRICO, DOBLE CIEGO Y CONTROLADO CON PLACEBO PARA EVALUAR LA EFICACIA Y LA SEGURIDAD DE RO7234292 (RG6042) ADMINISTRADO POR VÍA INTRATECAL EN PACIENTES CON ENFERMEDAD DE HUNTINGTON MANIFIESTA.

Datos básicos

Código:
BN40423
Protocolo:
BN40423
EUDRACT:
2018-002987-14
NCT:
Centro:
HOSPITAL UNIVERSITARI I POLITÈCNIC LA FE
Dotación:
Año de incio:
2019
Año de finalización:
2022
ENSAYO CLÍNICO INTERNACIONAL

Documentos

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Participantes

Grupos

Financiadores - Promotores

ROCHE FARMA, S.A.

Resultados del Ensayo Clínico

2019 SEFH National Survey: service portfolio, care activities, education and research in Spain's hospital pharmacy departments.

Pérez-Encinas M; (...); Calleja-Hernández MÁ

Article. 10.7399/fh.11611. 2021


A cross-sectional and longitudinal study on the protective effect of bilingualism against dementia using brain atrophy and cognitive measures.

Costumero V; (...); Ávila C

Article. 10.1186/s13195-020-0581-1. 2020


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 Multiple Stakeholder Multicriteria Decision Analysis in Diabetic Macular Edema Management: The MULTIDEX-EMD Study.

de Andrés-Nogales F; (...); Martínez-Olmos J

Article. 10.1007/s41669-020-00201-2. 2020


A new definition and refocus of pharmaceutical care: the Barbate Document

Morillo-Verdugo R; (...); Poveda-Andrés JL

Article. 10.7399/fh.11389. 2020


Adherence and adverse events of intraperitoneal chemotherapy in optimally debulked ovarian cancer patients: Real-life study.

Ballesta-López O; (...); Poveda-Andrés JL

Article. 10.1177/1078155220915953. 2020


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 on FDG PET Images Identifies Mild Cognitive Impairment Patients with Neurodegenerative Disease.

Prats-Climent, Joan; (...); Marti-Bonmati, Luis

Article. 10.1007/s10916-022-01836-w. 2022


Assessment of apolipoprotein E genotype for ß-amyloid status prediction.

Peña-Bautista C; (...); Chafer-Pericas, Consuelo

Article. 10.2174/1567205019666211223141524. 2021


Assessment of lipid peroxidation and artificial neural network models in early Alzheimer Disease diagnosis.

Peña-Bautista C; (...); Cháfer-Pericás C

Article. 10.1016/j.clinbiochem.2019.07.008. 2019


Assessment of Lipid Peroxidation in Alzheimer's Disease Differential Diagnosis and Prognosis.

Ferre-Gonzalez, Laura; (...); Chafer-Pericas, Consuelo

Article. 10.3390/antiox11030551. 2022


Assessment of Screening Approach in Early and Differential Alzheimer's Disease Diagnosis.

Ferré-González L; (...); Cháfer-Pericás C

Article. 10.3390/antiox10111662. 2021


Awareness of Diagnosis in Persons with Early-Stage Alzheimer's Disease: An Observational Study in Spain.

Villarejo-Galende, Alberto; (...); Maurino, Jorge

Article. 10.1007/s40120-022-00367-3. 2022


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


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


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


Clinical Utility of Plasma Lipid Peroxidation Biomarkers in Alzheimer's Disease Differential Diagnosis

Pena-Bautista, Carmen; (...); Chafer-Pericas, Consuelo

Article. 10.3390/antiox9080649. 2020


COGNITIVE FUNCTION FOLLOWING AN INTRACEREBRAL HEMORRHAGE ASSOCIATED WITH CEREBRAL AMYLOID ANGIOPATHY.

Gimenez, C; (...); Lago, A

Meeting Abstract. 2020


Comparison of pharmacokinetic estimates using generic and specific population pharmacokinetic models of plasma-derived factor VIII/VWF using WAPPS-Hemo

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

Meeting Abstract. 2020


COSTS OF THE MANAGEMENT OF HEMOPHILIA A WITH INHIBITORS IN SPAIN

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

Meeting Abstract. 2020


Costs of the management of hemophilia A with inhibitors in Spain

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

Article. 10.33393/grhta.2021.2234. 2021


Depression and Suicide Risk in Mild Cognitive Impairment: The Role of Alzheimer's Disease Biomarkers

Ferrer-Cairols, Ines; (...); Salvador, Alicia

Article. 10.7334/psicothema2022.103. 2022


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


Early neurotransmission impairment in non-invasive Alzheimer Disease detection

Pena-Bautista, Carmen; (...); Cháfer-Pericás C

Article. 10.1038/s41598-020-73362-z. 2020


Efecto de la adición de fortificantes y de módulo de proteínas en la osmolalidad de la leche materna donada.

Torres Martínez E; (...); Vento M

Article. 10.1016/j.anpedi.2020.03.009. 2020


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

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

Article. 10.1159/000517813. 2021


Effects of bilingualism on white matter atrophy in mild cognitive impairment: a diffusion tensor imaging study.

Marin-Marin L; (...); Ávila C

Article. 10.1111/ene.14135. 2020


Epigenomics and Lipidomics Integration in Alzheimer Disease: Pathways Involved in Early Stages.

Peña-Bautista C; (...); Chafer-Pericas, Consuelo

Article. 10.3390/biomedicines9121812. 2021


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


Free radicals in Alzheimer's disease: Lipid peroxidation biomarkers

Pena-Bautista, Carmen; (...); Chafer-Pericas, Consuelo

Review. 10.1016/j.cca.2019.01.021. 2019


Genome-wide association analysis of dementia and its clinical endophenotypes reveal novel loci associated with Alzheimer's disease and three causality networks: The GR@ACE project

Moreno-Grau, S; (...); GR ACE Study Grp

Article. 10.1016/j.jalz.2019.06.4950. 2019


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


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


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


Imaging Biomarkers in Amyotrophic Lateral Sclerosis

Cerda Alberich, Leonor; (...); Marti-Bonmati, Luis

Editorial Material. 10.1007/978-1-0716-1712-0_20. 2022


Impact of combinations of single-nucleotide polymorphisms of anthracycline transporter genes upon the efficacy and toxicity of induction chemotherapy in acute myeloid leukemia.

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

Article. 10.1080/10428194.2020.1839650. 2020


Impact of the therapeutic positioning report in the P&R process in Spain: analysis of orphan drugs approved by the European Commission and reimbursed in Spain from 2003 to 2019

Badia X; (...); Hernández C

Article. 10.1186/s13023-020-01507-4. 2020


Implementation and results of a risk-sharing scheme for enzyme replacement therapy in lysosomal storage diseases

Edo-Solsona, MD, Vitoria-Minana, I, Poveda-Andres, JL

Article. 10.7399/fh.11262. 2020


Influence of polymorphisms in anthracyclines metabolism genes in the standard induction chemotherapy of acute myeloid leukemia.

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

Article. 10.1097/FPC.0000000000000431. 2021


Intravitreal melphalan therapy for vitreous seeds in retinoblastoma: Implementation and outcomes of a new chemotherapy protocol.

Solana-Altabella A; (...); Poveda JL

Article. 10.1177/1078155220904410. 2020


Involvement of interleukin 6 in SARS-CoV-2 infection: siltuximab as a therapeutic option against COVID-19

Palanques-Pastor, T, Lopez-Briz, E, Andres, JLP

Article. 10.1136/ejhpharm-2020-002322. 2020


Isoprostanoids Levels in Cerebrospinal Fluid Do Not Reflect Alzheimer's Disease

Pena-Bautista, Carmen; (...); Chafer-Pericas, Consuelo

Article. 10.3390/antiox9050407. 2020


Lipid Peroxidation Assessment in Preclinical Alzheimer Disease Diagnosis

Pena-Bautista, Carmen; (...); Cháfer-Pericás C

Article. 10.3390/antiox10071043. 2021


Lipid peroxidation biomarkers correlation with medial temporal atrophy in early Alzheimer Disease

Pena-Bautista, Carmen; (...); Chafer-Pericas, Consuelo

Article. 10.1016/j.neuint.2019.104519. 2019


Lipid peroxidation in neurodegeneration.

Peña-Bautista C; (...); Cháfer-Pericás C

Review. 10.1016/j.cca.2019.07.037. 2019


Lipids as early and minimally invasive biomarkers for Alzheimer disease.

Casas-Fernandez, Esther; (...); Chafer-Pericas, Consuelo

Article. 10.2174/1570159X19666211102150955. 2021


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

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

Article. 2021

  • 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


Metabolic Phenotyping in Prostate Cancer Using Multi-Omics Approaches.

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

Article. 10.3390/cancers14030596. 2022


Metabolomics study to identify plasma biomarkers in alzheimer disease: ApoE genotype effect.

Peña-Bautista C; (...); Cháfer-Pericás C

Article. 10.1016/j.jpba.2019.113088. 2020


Metformin to treat Huntington disease: a pleiotropic drug against a multi-system disorder.

Trujillo-Del Río C; (...); Vázquez-Manrique RP

Article. 10.1016/j.mad.2022.111670. 2022


Metyrapone as treatment in the neonatal McCune-Albright syndrome

de Mingo, Carmen; (...); Garcia-Robles, Ana

Article. 10.1515/jpem-2020-0036. 2020


Monitoring coagulation factors during surgery. A systematic review

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

Review. 10.7399/fh.11766. 2021


Monitoring contamination of hazardous drug compounding surfaces at hospital pharmacy departments. A consensus Statement. Practice guidelines of the Spanish Society of Hospital Pharmacists (SEFH).

Valero-García S; (...); Delgado-Sánchez O

Article. 10.7399/fh.11655. 2021


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 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


Neuropsychological assessment and cortisol levels in biofluids from early Alzheimer's disease patients

Pena-Bautista, C.; (...); Chafer-Pericas, C.

Article. 10.1016/j.exger.2019.05.007. 2019


New insights into the genetic etiology of Alzheimer's disease and related dementias

Bellenguez, Celine; (...); CHARGE

Article. 10.1038/s41588-022-01024-z. 2022


New screening approach for Alzheimer's disease risk assessment from urine lipid peroxidation compounds.

Peña-Bautista C; (...); Chafer-Pericas, C

Article. 10.1038/s41598-019-50837-2. 2019


Novel Ultrasensitive Detection Technologies for the Identification of Early and Minimally Invasive Alzheimer's Disease Blood Biomarkers.

Alvarez-Sanchez, Lourdes; (...); Chafer-Pericas, Consuelo

Article. 10.3233/JAD-215093. 2022


Obstructive sleep apnea and Alzheimer's disease-related cerebrospinal fluid biomarkers in mild cognitive impairment.

Díaz-Román M; (...); Gómez E

Article. 10.1093/sleep/zsaa133. 2021


Oxidative Damage of DNA as Early Marker of Alzheimer's Disease.

Peña-Bautista C; (...); Cháfer-Pericás C

Article. 10.3390/ijms20246136. 2019


Paracetamol vs. Ibuprofen in Preterm Infants With Hemodynamically Significant Patent Ductus Arteriosus: A Non-inferiority Randomized Clinical Trial Protocol

Garcia-Robles, Ana; (...); Carrascosa, MA

Article. 10.3389/fped.2020.00372. 2020


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

  • Open Access.

Person-centered Assessment in Early Alzheimers Disease (P1-1.Virtual)

Villarejo Galende, Alberto; (...); Maurino, Jorge

Meeting Abstract. 2022


Pharmaceutical care to hospital outpatients during the COVID-19 pandemic. Telepharmacy

Margusino-Framiñán L; (...); Morillo-Verdugo R

Article. 10.7399/fh.11498. 2020


Pharmacometabolomics by NMR in Oncology: A Systematic Review.

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

Article. 10.3390/ph14101015. 2021


Pharmacotherapeutic management of advanced therapy medicinal products

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

Article. 10.7399/fh.13036. 2022


PK-GUIDED SWITCH BETWEEN STANDARD HALF-LIFE AND EXTENDED HALF-LIFE FACTOR VIII PRODUCTS

Vericat, JEM; (...); Iorio, A

Meeting Abstract. 2020


Plasma alterations in cholinergic and serotonergic systems in early Alzheimer Disease: Diagnosis utility.

Peña-Bautista C; (...); Cháfer-Pericás C

Article. 10.1016/j.cca.2019.10.023. 2020


Plasma isoprostanoids assessment as Alzheimer's disease progression biomarkers.

Peña-Bautista C; (...); Cháfer-Pericás C

Article. 10.1111/jnc.15183. 2020


Plasma metabolomics in early Alzheimer's disease patients diagnosed with amyloid biomarker

Pena-Bautista, Carmen; (...); Chafer-Pericas, Consuelo

Article. 10.1016/j.jprot.2019.04.008. 2019


Preparación y administración de perfusiones de insulina en neonatología: Encuesta nacional.

García-Robles A; (...); Aguar-Carrascosa M

Letter. 10.1016/j.anpedi.2020.06.008. 2021


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


Presenilin-1 Mutations Are a Cause of Primary Lateral Sclerosis-Like Syndrome

Vazquez-Costa, JF; (...); SEVILLA, T

Article. 10.3389/fnmol.2021.721047. 2021


Proactive therapeutic drug monitoring and pharmacogenetic analysis in inflammatory bowel disease: A systematic review

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

Review. 10.7399/fh.11780. 2021


Prognostic value of cerebrospinal fluid biomarkers in mild cognitive impairment due to Alzheimer disease.

López-Cuevas R; (...); Cháfer-Pericás C

Article. 10.1016/j.nrl.2020.07.026. 2020


Radiological evaluation of the postsurgical middle ear.

Mazon, M.; (...); Carreres-Polo, J.

Article. 10.1016/j.rx.2021.04.005. 2021


Radiological evaluation of the postsurgical middle ear.

Mazón M; (...); Carreres-Polo J

Article. 10.1016/j.rxeng.2021.04.006. 2021


Recent evidence in epigenomics and proteomics biomarkers for early and minimally invasive diagnosis of Alzheimer's and Parkinson's diseases.

Mayo, Sonia; (...); Chafer-Pericas, Consuelo

Review. 10.2174/1570159X19666201223154009. 2020


Relevance of the interplay between amyloid and tau for cognitive impairment in early Alzheimer's disease

Timmers, M; (...); Streffer, JR

Article. 10.1016/j.neurobiolaging.2019.03.016. 2019


Role of the nigrosome 1 absence as a biomarker in amyotrophic lateral sclerosis

Isabel Moreno-Gambin, Maria; (...); Vázquez-Costa JF

Article. 10.1007/s00415-021-10729-w. 2021


SEFH National Survey-2019: general characteristics, staffing, material resources and information systems in Spain's hospital pharmacy departments.

Pérez-Encinas M; (...); Calleja-Hernández MÁ

Article. 10.7399/fh.11565. 2020


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


Stress and neurodegeneration.

Peña-Bautista C; (...); Cháfer-Pericás C

Review. 10.1016/j.cca.2020.01.019. 2020


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

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

Review. 10.3390/pharmaceutics14040878. 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 MAPT H1 Haplotype Is a Risk Factor for Alzheimer's Disease in APOE epsilon 4 Non-carriers

Sanchez-Juan, P; (...); DEGESCO Consortium

Article. 10.3389/fnagi.2019.00327. 2019


Towards a symbiotic relationship between big data, artificial intelligence, and hospital pharmacy

Del Rio-Bermudez, C; (...); Poveda, JL

Editorial Material. 10.1186/s40545-020-00276-6. 2020


Undetectable levels of adalimumab in clinical practice: Should we say goodbye to the drug?

Bejar, S; (...); Mateu, PN

Meeting Abstract. 2020


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