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  3. ENSAYO CLINICO FASE III, MULTICENTRICO, DOBLE CIEGO, CONTROLADO CON PLACEBO, ALEATORIZADO, CON GRUPOS PARALELOS, EN PACIENTES CON UN PRIMER EPISODIO DE DESMIELINIZACION SUGESTIVO DE ESCLEROSIS MULTIPLE, PARA EVALUAR LA SEGURIDAD, TOLERANCIA Y EFICACIA DE8 MUI (250 MG) DE INTERFERON-BETA-1B (BETAFERON/BETASERON) ADMINISTRADO POR VIA SUBCUTANEA A SIAS ALTERNOS POR UN PERIODO DE HASTA 24 MESES.

ENSAYO CLINICO FASE III, MULTICENTRICO, DOBLE CIEGO, CONTROLADO CON PLACEBO, ALEATORIZADO, CON GRUPOS PARALELOS, EN PACIENTES CON UN PRIMER EPISODIO DE DESMIELINIZACION SUGESTIVO DE ESCLEROSIS MULTIPLE, PARA EVALUAR LA SEGURIDAD, TOLERANCIA Y EFICACIA DE8 MUI (250 MG) DE INTERFERON-BETA-1B (BETAFERON/BETASERON) ADMINISTRADO POR VIA SUBCUTANEA A SIAS ALTERNOS POR UN PERIODO DE HASTA 24 MESES.

Datos básicos

Código:
304747
Protocolo:
304747
EUDRACT:
NO PROCEDE
NCT:
Centro:
Dotación:
Año de incio:
Año de finalización:
ENSAYO CLÍNICO

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Financiadores - Promotores

SCHERING ESPAÑA S.A

Resultados del Ensayo Clínico

A novel TRMT5 mutation causes a complex inherited neuropathy syndrome: the role of nerve pathology in defining a demyelinating neuropathy.

Argente-Escrig, Herminia; (...); Sevilla, Teresa

Article. 10.1111/nan.12817. 2022


An algorithm to predict intrathecal synthesis of IgG with high efficiency

Tortosa-Carreres, Jordi; (...); Casanova, Bonaventura

Meeting Abstract. 2023


Analysis of Juvenile Onset Pompe Disease patients included in the Spanish Pompe Registry

Martinez Marin, R.; (...); Diaz Manera, J.

Meeting Abstract. 2022


Analysis of muscle magnetic resonance imaging of a large cohort of patient with VCP-mediated disease reveals characteristic features useful for diagnosis.

Esteller D; (...); Díaz-Manera J

Article. 10.1007/s00415-023-11862-4. 2023


Anti-CD20 monoclonal antibodies in primary progressive multiple sclerosis: a real-life comparative study of rituximab vs. ocrelizumab

Alcala, C.; (...); Casanova, B.

Meeting Abstract. 2021


AntimiR treatment corrects myotonic dystrophy primary cell defects across several CTG repeat expansions with a dual mechanism of action

Cerro-Herreros, Estefania; (...); Artero, Ruben

Article. 10.1126/sciadv.adn6525. 2024


Assessment of Plasma and Cerebrospinal Fluid Biomarkers in Different Stages of Alzheimer's Disease and Frontotemporal Dementia.

Álvarez-Sánchez L; (...); Cháfer-Pericás C

Article. 10.3390/ijms24021226. 2023


Association of Serum Neurofilament Light Chain Levels at Disease Onset With Disability Worsening in Patients With a First Demyelinating Multiple Sclerosis Event Not Treated With High-Efficacy Drugs.

Monreal, Enric; (...); Villar LM

Article. 10.1001/jamaneurol.2023.0010. 2023


Asymptomatic HyperCKemia in the Pediatric Population A Prospective Study Utilizing Next-Generation Sequencing and Ancillary Tests

Marti, Pilar; (...); Vilchez, Juan Jesus

Article. 10.1212/WNL.0000000000210116. 2025


Autologous hematopoietic stem cell transplantation in multiple sclerosis: updating outcomes in the Valencian cohort.

Boix Lago, A.; (...); Casanova Estruch, B.

Meeting Abstract. 2023


Automatic etiological classification of stroke thrombus digital photographs using a deep learning model

Lucero-Garofano, Alvaro; (...); Manjon, Jose V.

Article. 10.3389/fneur.2025.1534845. 2025


Case Report: Exacerbation of Relapses Following mRNA COVID-19 Vaccination in Multiple Sclerosis: A Case Series.

Quintanilla-Bordás C; (...); Casanova B

Article. 10.3389/fneur.2022.897275. 2022


Cerebrospinal fluid kappa free light chains and IgM index for diagnosis and prognosis in multiple sclerosis

Gil-Perotin, S.; (...); Casanova, B.

Meeting Abstract. 2021


Cervical spinal cord T2 lesions independently predict early conversion to secondary progressive multiple sclerosis: a longitudinal 10-year study

Lacruz-Ballester, L.; (...); Casanova-Estruch, B.

Meeting Abstract. 2021


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 and genetic spectrum of a large cohort of delta-sarcoglycan muscular dystrophy

Alonso-Perez, J; (...); Diaz-Manera, J

Meeting Abstract. 10.1016/j.nmd.2021.07.202. 2021

  • Open Access.

Clinical characteristics and impact on patient-reported outcomes and quality of life of people with ambulatory secondary progressive multiple sclerosis: DISCOVER study

Oreja-Guevara, Celia; (...); Rio, Jordi

Article. 10.1016/j.msard.2024.105787. 2024


Clinical features, mutation spectrum and factors related to reaching molecular diagnosis in a cohort of patients with distal myopathies.

Muelas, Nuria; (...); Vilchez, Juan J

Article. 10.1007/s00415-024-12821-3. 2025


Clinical trajectories of patients with multiple sclerosis from onset and their relationship with serum neurofilament light chain levels

Quintanilla-Bordas, Carlos; (...); Casanova, Bonaventura

Article. 10.3389/fneur.2024.1477335. 2024


Clot Composition Analysis as a Diagnostic Tool to Gain Insight into Ischemic Stroke Etiology: A Systematic Review

Aliena-Valero, Alicia; (...); Salom, Juan B.

Article. 10.5853/jos.2021.02306. 2021


Comparative Assessment of Simoa and Lumipulse for Measuring Serum Neurofilament Light Chain in Multiple Sclerosis Patients

Gasque-Rubio, Raquel; (...); Perez-Miralles, Francisco

Article. 10.1155/2024/1950913. 2024


Consensus on early detection of disease progression in patients with multiple sclerosis

Meca-Lallana, Jose E.; (...); Oreja-Guevara, Celia

Article. 10.3389/fneur.2022.931014. 2022


Correction to: Analysis of muscle magnetic resonance imaging of a large cohort of patient with VCP-mediated disease reveals characteristic features useful for diagnosis.

Esteller D; (...); Díaz-Manera J

Correction. 10.1007/s00415-023-12178-z. 2024


CRISPR-Cas9 editing of a TNPO3 mutation in a muscle cell model of limb-girdle muscular dystrophy type D2.

Poyatos-Garcia, Javier; (...); Vilchez, Juan Jesus

Article. 10.1016/j.omtn.2023.01.004. 2023


Characterization of the gait in patients with relapsing-remitting multiple sclerosis and secondary progressive multiple sclerosis measured by FeetMe (R) integrated sensor insole system: Results of the interim analysis

Izquierdo Ayuso, G.; (...); Casanova Estruch, B.

Meeting Abstract. 2021


Charcot-Marie-Tooth disease due to MORC2 mutations in Spain

Sivera R; (...); Sevilla T

Article. 10.1111/ene.15001. 2021


Deletion of exons 45 to 55 in the DMD gene: from the therapeutic perspective to the in vitro model

Poyatos-Garcia, Javier; (...); Vilchez, Juan J

Article. 10.1186/s13395-024-00353-3. 2024


Design and Validation of an Expanded Disability Status Scale Model in Multiple Sclerosis.

Barreiro-Gonzalez, Antonio; (...); Casanova, Bonaventura

Article. 10.1159/000519772. 2022


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


Digenic inheritance involving a muscle-specific protein kinase and the giant titin protein causes a skeletal muscle myopathy.

Topf, Ana; (...); Straub, Volker

Article. 10.1038/s41588-023-01651-0. 2024


Disease modifying therapy switching in relapsing multiple sclerosis: A Delphi consensus of the demyelinating expert group of the Spanish society of neurology.

Brieva, Luis; (...); Moral, Ester

Article. 10.1016/j.msard.2022.103805. 2022


Disseminated toxoplasma infection after hematopoietic stem cell transplantation with myositis and encephalitis.

Asensi Cantó P; (...); Guerreiro M

Article. 10.1111/tid.14067. 2023


Does benign multiple sclerosis exist?

Verdini Martinez, Laura; (...); Casanova, Bonaventura

Meeting Abstract. 2023


Dynamic 18F-FDG PET to detect differences among patients with progressive and relapsing multiple sclerosis: a pilot study

Quintanilla Bordas, Carlos; (...); Casanova, Bonaventura

Meeting Abstract. 2023


Dystrophinopathy Phenotypes and Modifying Factors in DMD Exon 45-55 Deletion

Poyatos-Garcia, Javier; (...); Jesus Vilchez, Juan

Article. 10.1002/ana.26461. 2022


Early Alzheimer's Disease Screening Approach Using Plasma Biomarkers

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

Article. 10.3390/ijms241814151. 2023


Early beginning of alemtuzumab: Changing the multiple sclerosis treatment paradigm. Interim analysis of the LEMVIDA study.

Meca-Lallana, J E; (...); Calles Hernandez, C

Article. 10.1016/j.nrleng.2021.06.006. 2023


Early beginning of alemtuzumab: changing the multiple sclerosis treatment paradigm. Interim analysis of the LEMVIDA study

Meca-Lallana, J. E.; (...); Hernandez, C. Calles

Article. 10.1016/j.nrl.2021.06.007. 2024


Economic impact and clinical profile of the secondary progressive multiple sclerosis (SPMS) patient: the DISCOVER study

Oreja-Guevara, C.; (...); Meca-Lallana, J. E.

Meeting Abstract. 2021


Eculizumab for a catastrophic relapse in NMOSD: case report.

Gorriz, David; (...); Casanova, Bonaventura

Article. 10.1007/s10072-023-06971-x. 2023


Effectiveness and Safety of Teriflunomide in Relapsing-Remitting Multiple Sclerosis and Improvements in Quality of Life: Results from the Real-World TERICARE Study.

Meca-Lallana JE; (...); Llarena C

Article. 10.1007/s40120-023-00557-7. 2023


Effectiveness of rituximab vs. ocrelizumab for the treatment of primary progressive multiple sclerosis: a real-world observational study.

Alcala, Carmen; (...); Casanova, Bonaventura

Article. 10.1007/s00415-022-10989-0. 2022


Elevation of serum neurofilament light-chain levels disclose possible occult progressive multifocal leukoencephalopathy and immune reconstitution syndrome in a patient receiving ozanimod: a case report.

Quintanilla-Bordás C; (...); Pérez-Miralles FC

Case Reports. 10.3389/fimmu.2024.1465678. 2024


Escalation vs. Early Intense Therapy in Multiple Sclerosis.

Casanova, Bonaventura, Quintanilla-Bordas, Carlos, Gascon, Francisco

Article. 10.3390/jpm12010119. 2022


Evaluating the complement C1q levels in serum and cerebrospinal fluid in multiple sclerosis patients: Could it serve as a valuable marker in clinical practice?

Tortosa-Carreres J; (...); Pérez-Miralles FC

Article. 10.1016/j.jneuroim.2024.578428. 2024


Expanding the Clinical Spectrum of DRP2-Associated Charcot-Marie-Tooth Disease.

Sivera R; (...); Sevilla T

Article. 10.1212/WNL.0000000000209174. 2024


Expanding the phenotype of GARS1 mutations

Sivera, R.; (...); Teresa, S.

Meeting Abstract. 2023


Givinostat in DMD: results of the Epidys Study

Mercuri, E.; (...); McDonald, C.

Meeting Abstract. 10.1016/j.nmd.2022.07.223. 2022

  • Open Access.

HIGH CELL-FREE HEMOGLOBIN AND IRON LEVELS IN CLOTS OF COVID-19 STROKE PATIENTS: A NOVEL MECHANISM LINKED TO SARS-COV-2 INDUCED PROTHROMBOTIC STATE

Paya, M.; (...); Segura, T.

Meeting Abstract. 2024


High Levels of Cerebrospinal Fluid Kappa Free Light Chains Relate to IgM Intrathecal Synthesis and Might Have Prognostic Implications in Relapsing Multiple Sclerosis.

Castillo-Villalba, Jessica; (...); Casanova, Bonaventura

Article. 10.3389/fimmu.2022.827738. 2022


Human skeletal myopathy myosin mutations disrupt myosin head sequestration

Carrington, Glenn; (...); Ochala, Julien

Article. 2023


Human skeletal myopathy myosin mutations disrupt myosin head sequestration.

Carrington, Glenn; (...); Ochala, Julien

Article. 10.1172/jci.insight.172322. 2023


Improvements in Quality of Life of Patients with Multiple Sclerosis receiving Alemtuzumab in Clinical Practice: LEMVIDA study

Meca Lallana, Jose; (...); Forner, Mireia

Meeting Abstract. 10.1212/WNL.0000000000202381. 2023


Improvements in quality of life of patients with multiple sclerosis receiving alemtuzumab in clinical practice: the LEMVIDA study.

Meca-Lallana, Jose Eustasio; (...); Toledo, Baldo

Article. 10.1186/s41687-024-00822-9. 2024


Improving the efficiency of free kappa light chains as diagnostic biomarker of Multiple Sclerosis by using a novel algorithm.

Tortosa-Carreres J; (...); Pérez-Miralles FC

Article. 10.1016/j.msard.2023.104997. 2023


Insights into phenotypic variability caused by GARS1 pathogenic variants.

Jiménez-Jiménez J; (...); Sivera R

Article. 10.1111/ene.16416. 2024


ITPR3-associated neuropathy: Report of a further family with adult onset intermediate Charcot-Marie-Tooth disease.

Cabello-Murgui, Javier; (...); Sivera, Rafael

Article. 10.1111/ene.16485. 2024

  • Open Access.

KY mutations are a cause of distal neuromyopathies

Muelas, N.; (...); Vilchez, J.

Meeting Abstract. 2023


Long-term efficacy of alemtuzumab in multiple sclerosis: a real word multicenter Spanish experience

Rubio Alcantud, Almudena; (...); Casanova, Bonaventura

Meeting Abstract. 2023


Milestones of Precision Medicine: An Innovative, Multidisciplinary Overview

Garcia-Foncillas, J; (...); Gomez, MVP

Review. 10.1007/s40291-021-00544-4. 2021


miRNA Signature in CSF From Patients With Primary Progressive Multiple Sclerosis.

Munoz-San Martin, Maria; (...); Ramio-Torrenta, Lluis

Article. 10.1212/NXI.0000000000200069. 2023


Mitochondrial developmental encephalopathy with bilateral optic neuropathy related to homozygous variants in IMMT gene.

Marco-Hernández AV; (...); Martínez-Castellano F

Article. 10.1111/cge.14093. 2022


Muscle MRI-phenotyping of patients with likely pathogenic anoctamin 5 variants

Poulsen, N.; (...); Vissing, J.

Meeting Abstract. 10.1016/j.nmd.2024.07.187. 2024

  • Open Access.

Myosin ATPase inhibition fails to rescue the metabolically dysregulated proteome of nebulin-deficient muscle.

Laitila, Jenni; (...); Ochala, Julien

Article. 10.1113/JP286870. 2024


Myosin dysregulation in nemaline myopathy

Laitila, J.; (...); Ochala, J.

Article. 10.1016/j.nmd.2022.07.017. 2022

  • Open Access.

NEB mutations disrupt the super-relaxed state of myosin and remodel the muscle metabolic proteome in nemaline myopathy.

Ranu, Natasha; (...); Ochala, Julien

Article. 10.1186/s40478-022-01491-9. 2023


New developments and data highlights in the international myotubular and centronuclear myopathy patient registry

Laitila, J.; (...); Ochala, J.

Meeting Abstract. 10.1016/j.nmd.2022.07.018. 2022

  • Open Access.

NFL during acute spinal cord lesions in MS: a hurdle for the detection of inflammatory activity.

Alcala, C.; (...); Casanova, B.

Article. 10.1007/s00415-021-10926-7. 2022


Oligoclonal M bands and cervical spinal cord lesions predict early secondary progressive multiple sclerosis.

Alcala Vicente, Carmen; (...); Casanova, Bonaventura

Article. 10.3389/fneur.2022.991596. 2022


Oligoclonal M bands distinguish two MS populations based on neurofilament light chain levels in patients without inflammatory activity

Castillo, J.; (...); Casanova, B.

Meeting Abstract. 2022


Oligoclonal M bands unveil occult inflammation in multiple sclerosis.

Casanova B; (...); Pérez-Miralles F

Article. 10.1016/j.msard.2022.104118. 2022


Perception of stigma in people with neuromyelitis optica spectrum disorders (PERSPECTIVES-NMO Study)

Lallana, Jose Meca; (...); Maurino, Jorge

Meeting Abstract. 2021


Potential Biomarkers Associated with Multiple Sclerosis Pathology.

Mathur, Deepali; (...); Casanova, Bonaventura

Article. 10.3390/ijms221910323. 2021


Preclinical characterization of antagomiR-218 as a potential treatment for myotonic dystrophy.

Cerro-Herreros, E; (...); Artero, R

Article. 10.1016/j.omtn.2021.07.017. 2021


Predictive potential of serum and cerebrospinal fluid biomarkers for disease activity in treated multiple sclerosis patients.

Tortosa-Carreres J; (...); Pérez-Miralles FC

Article. 10.1016/j.msard.2024.105734. 2024


Proprotein convertase subtilisin/kexin type 9 inhibitors in secondary prevention of vascular events in patients with stroke: Consensus document and practice guidance.

Gil-Núñez A; (...); Palacio E

Practice Guideline. 10.1016/j.nrleng.2020.11.014. 2022


Randomized phase 2 study of ACE-083, a muscle-promoting agent, in facioscapulohumeral muscular dystrophy.

Statland, Jeffrey M.; (...); Attie, Kenneth M.

Article. 10.1002/mus.27558. 2022


Recommendations for the Diagnosis and Treatment of Multiple Sclerosis Relapses.

Ramo-Tello, Cristina; (...); Rovira À

Article. 10.3390/jpm12010006. 2021


Renal function's impact on serum neurofilament levels in patients with multiple sclerosis: an exploratory analysis.

Tortosa-Carreres, Jordi; (...); Perez-Miralles, Francisco

Article. 10.1007/s10072-024-07772-6. 2024


Reperfusion therapy in acute ischaemic stroke due to cervical and cerebral artery dissection: Results from a Spanish multicentre study.

Campo-Caballero D; (...); Serena J

Article. 10.1016/j.nrleng.2020.10.012. 2023


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


Safety and Efficacy of ApTOLL in Patients With Ischemic Stroke Undergoing Endovascular Treatment: A Phase 1/2 Randomized Clinical Trial.

Hernandez-Jimenez, Macarena; (...); Ribo, Marc

Article. 10.1001/jamaneurol.2023.1660. 2023


Safety and efficacy of givinostat in boys with Duchenne muscular dystrophy (EPIDYS): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial.

Mercuri E; (...); McDonald CM

Article. 10.1016/S1474-4422(24)00036-X. 2024


Safety and efficacy of losmapimod in facioscapulohumeral muscular dystrophy (ReDUX4): a randomised, double-blind, placebo-controlled phase 2b trial.

Tawil R; (...); Jiang JG

Article. 10.1016/S1474-4422(24)00073-5. 2024


Serum biomarkers at disease onset for personalized therapy in multiple sclerosis.

Monreal E; (...); Villar LM

Article. 10.1093/brain/awae260. 2024


Serum Glial Fibrillary Acidic Protein and Neurofilament Light Chain Levels at Disease Onset for Prediction of the Risk of Disability Worsening in Patients with Multiple Sclerosis

Monreal, Enric; (...); Villar Guimerans, Luisa Maria

Meeting Abstract. 2023


Serum neurofilament light chain and glial fibrillary acidic protein levels at disease onset unveil immunological pathways of disability acquisition in multiple sclerosis

Monreal, Enric; (...); Villar Guimerans, Luisa Maria

Meeting Abstract. 2024


Serum Neurofilament Light Chain is a surrogate marker of NEDA-3 in Multiple Sclerosis

Gascon Gimenez, Francisco Guillermo; (...); Casanova, Bonaventura

Meeting Abstract. 2023


Spanish Pompe Registry: New data based on the 130 patients included

Marin, R. Martinez; (...); Manera, J. Diaz

Meeting Abstract. 2023


The cross-sectional area of the median nerve: An independent prognostic biomarker in amyotrophic lateral sclerosis.

Martinez-Paya, J J; (...); Vazquez-Costa, J F

Article. 10.1016/j.nrleng.2024.07.003. 2024


Treatment of multiple sclerosis with Rituximab: a multicenter Spanish experience

Alcala, C.; (...); Casanova, B.

Meeting Abstract. 2021


Treatment of multiple sclerosis with rituximab: A Spanish multicenter experience.

Gascon-Gimenez, Francisco; (...); Casanova, Bonaventura

Article. 10.3389/fneur.2023.1060696. 2023


Treatment of Multiple Sclerosis With Teriflunomide. Multicenter Study of Real Clinical Practice in the Valencian Community-Spain.

Landete, Lamberto; (...); Casanova, Bonaventura

Article. 10.3389/fneur.2021.727586. 2021


Use of NGS for diagnosis of asymptomatic hyperCKemia in childhood

Marti, P; (...); VILCHEZ, J

Meeting Abstract. 10.1016/j.nmd.2021.07.340. 2021

  • Open Access.

Vamorolone versus placebo and prednisone in Duchenne muscular dystrophy: results from a 24-week double-blind randomized trial

Guglieri, M; (...); Andres Sant Joan Deu Hosp

Meeting Abstract. 2021


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