ESTUDIO ALEATORIZADO, DOBLE-CIEGO, CONTROLADO CON PLACEBO Y CONTROL ACTIVO DE CARISBAMATO EN EL TRATAMIENTO DEL DOLOR NEUROPATICO EN NEUROPATIA PERIFERICA DIABETICA, SEGUIDO DE UNA FASE DE EXTENSION CIEGA

Datos básicos

Código:
CARISNPP2003
Protocolo:
CARISNPP2003
EUDRACT:
2008-008753-33
NCT:
Centro:
HOSPITAL UNIVERSITARI I POLITÈCNIC LA FE
Dotación:
Año de incio:
Año de finalización:
ENSAYO CLÍNICO

Documentos

  • No hay documentos

Participantes

Grupos

Financiadores - Promotores

JANSSEN CILAG INTERNATIONAL NV

Resultados del Ensayo Clínico


[ 177 Lu]Lu-DOTA-TATE and [ 131 I]MIBG Phenotypic Imaging-Based Therapy in Metastatic/Inoperable Pheochromocytomas and Paragangliomas: Comparative Results in a Single Center.

Prado-Wohlwend, Stefan; (...); Merino-Torres, Juan Francisco

Article. 10.3389/fendo.2022.778322. 2022


A description of variant transthyretin amyloidosis (ATTRv) stage 1 patients and asymptomatic carriers in Spain: the EMPATIa study

Davila, Lucia Galan; (...); Tarilonte, Patricia

Article. 10.1186/s13023-024-03304-9. 2024


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


A study of the phenotypic variability and disease progression in Laing myopathy through the evaluation of muscle imaging.

Muelas N; (...); Vilchez JJ

Article. 10.1111/ene.14630. 2021


Assessment of a well-differentiated pancreatic neuroendocrine tumor with 68 Ga-DOTATOC PET/CT, 68 Ga-DOTATOC PET/MRI and 99m Tc-octreotide SPECT/CT. What does each scan provide?

Prado-Wohlwend, S.; (...); Bello-Arques, P.

Editorial Material. 10.1016/j.remn.2020.05.012. 2021


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


Bi-allelic mutations in EGR2 cause autosomal recessive demyelinating neuropathy by disrupting the EGR2-NAB complex.

Lupo V; (...); Sevilla T

Article. 10.1111/ene.14512. 2020


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 profile, and assessment of disability in childhood hereditary motor neuropathy

Argente-Escrig, H; (...); Menezes, M

Meeting Abstract. 2020


Clinical characteristics and outcomes of thymoma associated myasthenia gravis.

Álvarez-Velasco R; (...); Cortés-Vicente E

Article. 10.1111/ene.14820. 2021


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, genetic and disability profile of pediatric distal hereditary motor neuropathy.

Argente-Escrig H; (...); Menezes MP

Article. 10.1212/WNL.0000000000011054. 2021


CXCR4: From Signaling to Clinical Applications in Neuroendocrine Neoplasms.

Sanchis-Pascual, David; (...); Merino-Torres, Juan Francisco

Article. 10.3390/cancers16101799. 2024


Characterizing SOD1 mutations in Spain. The impact of genotype, age, and sex in the natural history of the disease.

Vazquez-Costa, Juan F.; (...); Garcia-Redondo, Alberto

Article. 10.1111/ene.15661. 2022


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

Sivera R; (...); Sevilla T

Article. 10.1111/ene.15001. 2021


DEPRESSION IN PATIENTS WITH CHARCOT-MARIE-TOOTH DISEASE TYPE 1A (CMT1A): FINDINGS FROM A REAL-WORLD DIGITAL STUDY

Thomas, Florian; (...); Boutalbi, Youcef

Meeting Abstract. 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


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

Asensi Cantó P; (...); Guerreiro M

Article. 10.1111/tid.14067. 2023


Distal hereditary motor neuropathies: mutation spectrum and genotype-phenotype correlation.

Frasquet, Marina; (...); Lupo, Vincenzo

Article. 10.1111/ene.14700. 2021


DRP2 mutations as a cause of Charcot Marie Tooth in Spain

Sivera, R.; (...); Sevilla, T.

Meeting Abstract. 2023


Drug-refractory myasthenia gravis: Clinical characteristics, treatments, and outcome.

Cortes-Vicente, Elena; (...); Gallardo, Eduard

Article. 10.1002/acn3.51492. 2022


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

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

Article. 10.1002/ana.26461. 2022


Early Referral to an ALS Center Reduces Several Months the Diagnostic Delay: A Multicenter-Based Study.

Martínez-Molina M; (...); Vázquez-Costa JF

Article. 10.3389/fneur.2020.604922. 2020


Effects of Spinal Cord Stimulation in Patients with Small Fiber and Associated Comorbidities from Neuropathy After Multiple Etiologies

Canos-Verdecho, Angeles; (...); Morales-Suarez-Varela, Maria

Article. 10.3390/jcm14020652. 2025


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


Genomic and immune landscape Of metastatic pheochromocytoma and paraganglioma.

Calsina, Bruna; (...); Robledo, Mercedes

Article. 10.1038/s41467-023-36769-6. 2023


Genotype and phenotype spectrum of SORD neuropathy

Cortese, A; (...); SORD Nat Hist Study Grp

Meeting Abstract. 2021


Hereditary transthyretin amyloidosis caused by the Val142Ile variant in Spain.

de Frutos, Fernando; (...); Gonzalez-Costello, Jose

Article. 10.1016/j.rec.2024.12.012. 2025


Hereditary transthyretin amyloidosis caused by Val142Ile variant in Spain: phenotypic characteristics, geographic distribution and population frequency

Seminario, F. De Frutos; (...); Gonzalez-Costello, J.

Meeting Abstract. 10.1093/eurheartj/ehae666.2073. 2024

  • Open Access.

Impact of Diabetes Mellitus in Patients with Pancreatic Neuro-Endocrine Tumors: Causes, Consequences, and Future Perspectives.

Hernandez-Rienda, Lorena, Del Olmo-García MI, Merino-Torres JF

Article. 10.3390/metabo12111103. 2022


Impact of nutritional status in the quality of life (QoL) of patients with advanced gastroenteropancreatic (GEP) neuroendocrine neoplasms (NENs) in Spain: NUTRIGETNE Study

Del Olmo-Garcia, M.; (...); Argente Pla, M.

Meeting Abstract. 2024


Impact of SARS-CoV-2 infection and COVID-19 pandemic on the morbidity and mortality of amyotrophic lateral sclerosis patients in Valencia, Spain

Garcia-Casanova, Pilar H.; (...); Vazquez-Costa, Juan F.

Article. 10.1111/ene.16465. 2024


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.

Just a matter of weight? Final results from NUTRIGETNE study in patients with Gastroenteropancreatic (GEP) Neuroendocrine Neoplasms (NENs)

Pla, Argente M.; (...); Del Olmo-Garcia, M.

Meeting Abstract. 2024


MAML3-fusions modulate vascular and immune tumour microenvironment and confer high metastatic risk in pheochromocytoma and paraganglioma.

Monteagudo M; (...); Robledo M

Article. 10.1016/j.beem.2024.101931. 2024


Management of Hereditary Transthyretin Amyloidosis (ATTRv) Patients and Asymptomatic Carriers in Spain: The EMPATIa Study.

Losada Lopez, Ines; (...); Setaro, Francesca

Article. 10.3390/jcm13247587. 2024


Management of incidentally discovered appendiceal neuroendocrine tumors after an appendicectomy.

Muñoz de Nova JL; (...); Martin-Perez, Elena

Review. 10.3748/wjg.v28.i13.1304. 2022


Msi2 enhances muscle dysfunction in a myotonic dystrophy type 1 mouse model.

Sabater-Arcis, Maria; (...); Artero, Ruben

Article. 10.1016/j.bj.2023.100667. 2023


NATURAL HISTORY STUDY OF SORD NEUROPATHY

Cortese, Andrea; (...); Zuchner, Stephan

Meeting Abstract. 2022


Nusinersen in adult patients with 5q spinal muscular atrophy: Amulticenter observational cohorts' study.

Vazquez-Costa, Juan F.; (...); Hervas, David

Article. 10.1111/ene.15501. 2022


Nutritional status of patients with advanced gastroenteropancreatic (GEP) neuroendocrine neoplasms (NENs) in Spain - NUTRIGETNE study

Hernandez-Rienda, L.; (...); Del Olmo-Garcia, M.

Meeting Abstract. 2023


Onasemnogene Abeparvovec Administration via Peripherally Inserted Central Catheter: A Case Report.

Pitarch Castellano, Inmaculada; (...); Poveda Andres, Jose L

Case Reports. 10.3390/children11050590. 2024


Patient-reported impact of Charcot-Marie-Tooth disease: protocol for a real-world digital lifestyle study.

Thomas, Florian P.; (...); Boutalbi, Youcef

Review. 10.2217/nmt-2020-0044. 2021


PATIENT-REPORTED SYMPTOM BURDEN OF CHARCOT-MARIE-TOOTH DISEASE TYPE 1A (CMT1A): FINDINGS FROM A REAL-WORLD DIGITAL STUDY

Thomas, Florian; (...); Boutalbi, Youcef

Meeting Abstract. 2022


Patient-Reported Symptom Burden of Charcot-Marie-Tooth Disease Type 1A: Findings From an Observational Digital Lifestyle Study.

Thomas, Florian P; (...); Boutalbi, Youcef

Article. 10.1097/CND.0000000000000426. 2022


Pediatric inherited peripheral neuropathy: a prospective study at a Spanish referral center

Argente-Escrig H; (...); Sevilla T

Article. 10.1002/acn3.51432. 2021


Peptide Receptor Radionuclide Therapy with [(177)Lu]Lu-DOTA-TATE in Patients with Advanced GEP NENS: Present and Future Directions.

del Olmo-Garcia, Maria I.; (...); Merino-Torres, Juan F.

Article. 10.3390/cancers14030584. 2022


Phenotype and clinical outcomes of Glu89Lys hereditary transthyretin amyloidosis: a new endemic variant in Spain.

de Frutos, Fernando; (...); Garcia-Pavia, Pablo

Article. 10.1080/13506129.2022.2142110. 2022


Position Statement on the Diagnosis, Treatment, and Response Evaluation to Systemic Therapies of Advanced Neuroendocrine Tumors, With a Special Focus on Radioligand Therapy

Capdevila J; (...); Pubul V

Article. 10.1093/oncolo/oyab041. 2022


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

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

Article. 10.3389/fnmol.2021.721047. 2021


Prevention and Management of Hormonal Crisis during Theragnosis with LU-DOTA-TATE in Neuroendocrine Tumors. A Systematic Review and Approach Proposal

del Olmo-Garcia, MI; (...); Merino-Torres, JF

Review. 10.3390/jcm9072203. 2020


PRRT of 200 patients from the SEPTRALU registry: real-world data

Casanovas, MM; (...); Jimenez-Fonseca, P

Meeting Abstract. 2020


Quantitative magnetic resonance imaging assessment of muscle composition in myotonic dystrophy mice

Bargiela, Ariadna; (...); Artero, Ruben

Article. 10.1038/s41598-023-27661-w. 2023


Real life experience of tafamidis for the treatment of Spanish patients with Val30Met transthyretin amyloidosis with polyneuropathy.

Sanso, Maria Antonia Ribot; (...); Gonzalez-Moreno, Juan

Article. 10.1016/j.medcli.2024.01.008. 2024


Response to targeted radionuclide therapy with [131I]MIBG AND [177Lu]Lu-DOTA-TATE according to adrenal vs. extra-adrenal primary location in metastatic paragangliomas and pheochromocytomas: A systematic review.

Prado-Wohlwend, Stefan; (...); Merino-Torres JF

Article. 10.3389/fendo.2022.957172. 2022


Risdiplam in non-sitter patients aged 16years and older with 5q spinal muscular atrophy.

Nungo Garzon, Nancy Carolina; (...); Vazquez-Costa, Juan F

Article. 10.1002/mus.27804. 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 nipocalimab in adults with generalised myasthenia gravis (Vivacity-MG3): a phase 3, randomised double-blind, placebo-controlled study

Antozzi, Carlo; (...); Sun, Hong

Article. 2025


Safety and Efficacy of Nipocalimab in Patients With Generalized Myasthenia Gravis: Results From the Randomized Phase 2 Vivacity-MG Study

Antozzi, Carlo; (...); Arroyo, Santiago

Article. 10.1212/WNL.0000000000207937. 2024


Same-day comparative protocol PET/CT-PET/MRI [68Ga]Ga-DOTA-TOC in paragangliomas and pheochromocytomas: an approach to personalized medicine.

Prado-Wohlwend, Stefan; (...); Merino-Torres, Juan Francisco

Article. 10.1186/s40644-023-00521-6. 2023


SERUM AUTOANTIBODY LOWERING BY THE ANTI-FCRN MONOCLONAL ANTIBODY, NIPOCALIMAB, CORRELATES WITH CLINICAL IMPROVEMENT IN GENERALIZED MYASTHENIA GRAVIS PATIENTS

Guptill, Jeffrey; (...); Sun, Hong

Meeting Abstract. 2022


Somatostatin and Somatostatin Receptors: From Signaling to Clinical Applications in Neuroendocrine Neoplasms.

Del Olmo-Garcia MI; (...); Merino-Torres JF

Article. 10.3390/biomedicines9121810. 2021


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

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

Article. 10.1002/mdc3.13740. 2023


Survey for neuroendocrine tumors'standard of care - A multidisciplinary pilot study in Spanish specialists

Sampedro-Nunez, M; (...); Capdevila, J

Meeting Abstract. 2021


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


The NETFIT trial: Smart wearable medical devices to assess the quality of life of patients with metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NET)

Molina Cerrillomd, Javier; (...); Capdevila, Jaume

Meeting Abstract. 2023


Therapeutic potential of oleic acid supplementation in myotonic dystrophy muscle cell models.

Moreno, Nerea; (...); Artero, Ruben

Article. 10.1186/s40659-024-00496-z. 2024


Uncovering the genomic profiling of metastatic pheochromocytomas and paragangliomas: Leveraging plasma circulating tumor DNA for comprehensive genetic characterisation and monitoring

Arenillas, Lallana C.; (...); Toledo, R. A.

Meeting Abstract. 2024


Use of healthcare REsources and associated COsts in controlled versus uncontrolled carcinoid SYndrome in patients with neuroendocrine tumours: the RECOSY study

Custodio, A; (...); Villabona, C

Article. 10.1007/s12094-021-02608-7. 2021


Validación de la versión española de la Charcot-Marie-Tooth Disease Pediatric Scale (CMTPedS).

Pitarch-Castellano I; (...); Burns J

Article. 10.33588/rn.7403.2021489. 2022


Validation of Neuromyotype: A smart keyboard for the evaluation of spinal muscular atrophy patients.

Cortes, P Lizandra; (...); Vázquez-Costa JF

Article. 10.1016/j.nrleng.2022.05.001. 2022


VIVACITY-MG: A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE- BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, EFFICACY, PHARMACO-KINETICS, PHARMACODYNAMICS, AND IMMUNOGENICITY OF NIPOCALIMAB ADMINISTERED TO ADULTS WITH GENERALIZED MYASTHENIA GRAVIS

Antozzi, Carlo; (...); Arroyo, Santiago

Meeting Abstract. 2023


Vivacity-MG: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Nipocalimab Administered to Adults with Generalized Myasthenia Gravis

Guptill, Jeffrey; (...); Arroyo, Santiago

Meeting Abstract. 2021


WORK IMPACTS IN PATIENTS WITH CHARCOT-MARIE-TOOTH DISEASE TYPE 1A (CMT1A): FINDINGS FROM A REAL-WORLD DIGITAL STUDY

Thomas, Florian; (...); Boutalbi, Youcef

Meeting Abstract. 2022


Campos de estudio

Compartir