Portal de investigación
Estudio de fase II, aleatorizado, doble ciego y controlado con placebo para evaluar la eficacia, la seguridad, la tolerabilidad, la farmacocinética y la farmacodinámica de TAK-341 intravenoso en sujetos con atrofia multisistémica.
Datos básicos
- Código:
- TAK-341-2001
- Protocolo:
- TAK-341-2001
- EUDRACT:
- 2022-000336-28
- NCT:
- Centro:
- HOSPITAL UNIVERSITARI I POLITÈCNIC LA FE
- Dotación:
- Año de incio:
- 2022
- Año de finalización:
Objetivos del proyecto
Objetivo Principal: Evaluar la eficacia de TAK-341 versus placebo, medida por el cambio desde el inicio hasta la semana 52 en UMSARS Parte I, menos el elemento de función sexual, con colapso de las calificaciones de normal y leve en cada elemento. Objetivos Secundarios: Evaluar las concentraciones séricas de PK y LCR de TAK-341 en sujetos con MSA. Para evaluar la eficacia de TAK-341 frente a placebo: - según lo medido por el cambio desde el inicio hasta la semana 52 en los 11 ítems UMSARS especificado por Palma et al 2021. - medido por el cambio desde el inicio hasta la semana 52 en el total UMSARS. - según lo medido por el cambio desde el inicio hasta la Semana 52 en la Parte I UMSARS menos el ítem de función sexual (sin colapsar las calificaciones de los ítems de la escala). - según lo medido por el cambio desde el inicio hasta la Semana 52 en la Parte II UMSARS. - según lo medido por el cambio desde el inicio hasta la Semana 52 en el Clinical Escala Global Impression-Severity (CGI-S). - en las escalas de resultados en la enfermedad de Parkinson - Autonómica Disfunción (SCOPA-AUT). - medido por la supervivencia global a las 52 semanas.
Documentos
- No hay documentos
Grupos
Financiadores - Promotores
Resultados del Ensayo Clínico
"Venous cavernous malformation in the infraorbital canal with unusual presentation".
Solaz-Ruiz, M G; (...); Espana-Gregori, E
Article. 10.1016/j.oftale.2025.01.009. 2025
[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
Acute calcareous corneal degeneration in a patient with chronic graft-versus-host disease.
Ruiz, Marta Gema Solaz; (...); Gregori, Enrique Espana
Review. 10.22336/rjo.2024.10. 2024
Artificial intelligence for identification of candidates for device-aided therapy in Parkinson's disease: DELIST-PD study.
Freire-Alvarez, Eric; (...); Escamilla-Sevilla, Francisco
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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
Association between Tomographic Characteristics of Pterygium and Preoperative Anterior and Posterior Topography Measured by Anterior Segment Optical Coherence Tomography
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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
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
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
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
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
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
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
How can artificial intelligence optimize value-based contracting?
Poveda, Jose Luis; (...); Medrano, Ignacio H.
Letter. 10.1186/s40545-022-00475-3. 2022
Influence of Intravitreal Therapy on Choroidal Thickness in Patients with Diabetic Macular Edema.
Udaondo Mirete P; (...); Espana-Gregori, Enrique
Article. 10.3390/jcm12010348. 2023
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
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
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
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
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
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
Posterior Capsular Opacification and Glistening in Hydrophobic Monofocal Biaspheric Intraocular Lens Two Years After Implantation: A Case Control Study
Hervas-Ontiveros, Ana; (...); Cervino, Alejandro
Article. 10.1155/joph/3520219. 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
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
Prospective Study: Utility of Anterior Segment Optical Coherence Tomography to Identify Predictive Factors of Recurrence in Pterygium Surgery.
Aguilar-Gonzalez, Marina; (...); Peris-Martinez, Cristina
Article. 10.3390/jcm13164769. 2024
Purtscher-like retinopathy following carotid angioplasty and stenting in the treatment of severe carotid stenosis.
Solaz-Ruiz, M G; (...); Espana-Gregori, E
Article. 10.1177/11206721231204632. 2023
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
Spinocerebellar Ataxia 36 is a Frequent Cause of Hereditary Ataxia in Eastern Spain
Baviera-Munoz, Raquel; (...); Bataller, Luis
Article. 10.1002/mdc3.13740. 2023
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
Straatsma Syndrome and cataract: case report and review of the literature.
Blanca, Casado-Pelaez; (...); Enrique, Espana-Gregori
Review. 10.22336/rjo.2023.67. 2023
STUB1 Mutations as Possible Genetic Modifiers in Spinocerebellar Ataxia Type 8.
Baviera-Munoz, Raquel; (...); Aller, Elena
Article. 10.1002/mds.29910. 2024
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
Toxicity to intravitreal melphalan in a patient with retinoblastoma.
Solaz-Ruiz, Marta Gema; (...); Espana-Gregori, Enrique
Case Reports. 10.22336/rjo.2023.49. 2023
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
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
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
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
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