Portal de recerca
Estudio de fase II, aleatorizado, doble ciego y controlado con placebo para evaluar la eficacia y la seguridad de la pimavanserina para el tratamiento de la irritabilidad asociada al trastorno del espectro autista.
Dades bàsiques
- Protocol:
- ACP-103-069
- EURDRACT:
- 2021-005387-22
- NCT:
- Centre:
- HOSPITAL UNIVERSITARI I POLITÈCNIC LA FE
- Any inici:
- 2022
- Any de finalització:
- 2023
Objectius del projecte
Objetivo Principal: Objetivo principal de eficacia • Evaluar la eficacia de la pimavanserina en comparación con el placebo para el tratamiento de la irritabilidad asociada al TEA en niños y adolescentes. Objetivo de seguridad • Evaluar la seguridad y la tolerabilidad de la pimavanserina en comparación con el placebo para el tratamiento de la irritabilidad asociada al TEA en niños y adolescentes. Objetivo de farmacocinética • Caracterizar la farmacocinética (FC) de la pimavanserina en niños y adolescentes con TEA. Objetivo de farmacocinética/farmacodinámica • Caracterizar la relación farmacocinética/farmacodinámica (FC/FD) de la pimavanserina para el tratamiento de la irritabilidad asociada al TEA en niños y adolescentes. Objetivos Secundarios: Objetivos secundarios • Evaluar la eficacia de la pimavanserina en comparación con el placebo, en el tratamiento de los síntomas diferentes de la irritabilidad, en la magnitud de la mejora de la irritabilidad y en el índice de respuesta, en niños y adolescentes con TEA.
Documents
- No hi ha documents
Participants
Grups d'Investigació
Finançadors - Promotors
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
[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
A multi-criteria decision analysis on the value of nintedanib for interstitial lung diseases.
Zozaya, Neboa; (...); Verde, Luis
Article. 10.1017/S0266462322000459. 2022
Are Infants Born After an Episode of Suspected Preterm Labor at Risk of ADHD? A 30-Month Follow-up Study.
Navalon, Pablo; (...); Garcia-Blanco, Ana
Article. 10.1016/j.ajog.2022.05.065. 2022
Are Socially Relevant Scenes Abnormally Processed in Complex Trauma-Exposed Children?
Bertó C; (...); García-Blanco A
Article. 10.1007/s40653-023-00549-7. 2023
Assessing Executive Functioning in Schizophrenia: Concurrent and Discriminative Validity of a Novel Virtual Cooking Task.
Adriasola, Asier; (...); Mariano, Alcaniz Raya
Article. 10.1089/cyber.2023.0443. 2024
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
Biomarkers of oxidative stress and inflammation in urine samples of extremely preterm newborns and their association with risk for autism at age 6 months
Munoz, T. Bollain; (...); Pina-Camacho, L.
Meeting Abstract. 10.1192/j.eurpsy.2023.1222. 2023
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
Correction: Opinion, Use and Knowledge About Transcranial Magnetic Stimulation in Spain: A National Survey of Mental Health Professionals.
Sierra, Pilar; (...); Garcia-Blanco, Ana
Correction. 10.1007/s11126-024-10108-4. 2024
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
Characterization and assessment of executive functions through a virtual cooking task in euthymic patients with bipolar disorder.
Canada, Yolanda; (...); Alcaniz, Mariano
Article. 10.1016/j.jpsychires.2024.08.007. 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
Development of Moral Judgments in Impersonal and Personal Dilemmas in Autistic Spectrum Disorders from Childhood to Late Adolescence.
Labusch M; (...); García-Blanco A
Article. 10.1007/s10803-022-05795-6. 2022
Differentiation of Self and Social Functioning in Severe Mental Disorders
Plumed, Javier; (...); Garcia-Blanco, Ana
Article. 10.1037/pap0000422. 2023
Emotional Face Processing in Autism Spectrum Condition: A Study of Attentional Orienting and Inhibitory Control.
Sahuquillo-Leal R; (...); García-Blanco A
Article. 10.1007/s10803-023-06200-6. 2024
Genetic Variants Associated with Biological Treatment Response in Inflammatory Bowel Disease: A Systematic Review.
Plaza J; (...); Moret-Tatay I
Article. 10.3390/ijms25073717. 2024
How can artificial intelligence optimize value-based contracting?
Poveda, Jose Luis; (...); Medrano, Ignacio H.
Letter. 10.1186/s40545-022-00475-3. 2022
Impact of Maternal Health and Stress on Steroid Hormone Profiles in Human Milk: Implications for Infant Development.
Ten-Doménech I; (...); Kuligowski J
Article. 10.1016/j.jlr.2024.100688. 2024
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
Is relevant postpartum maternal psychopathology on the prognosis of psychomotor development in infants born after a threatened preterm labour across preschool ages?
Andreu, J.; (...); Garcia-Blanco, A.
Meeting Abstract. 10.1192/j.eurpsy.2024.1693. 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
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
Maternal mental health and trajectories of Preterm Behavioural Phenotype in infants born after a threatened preterm labour
Andreu, J.; (...); Garcia-Blanco, A.
Meeting Abstract. 10.1192/j.eurpsy.2024.1691. 2024
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
Opinion, Use and Knowledge About Transcranial Magnetic Stimulation in Spain: A National Survey of Mental Health Professionals
Sierra, Pilar; (...); Garcia-Blanco, Ana
Article. 10.1007/s11126-024-10073-y. 2024
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
Predictors of change in emotional regulation from 6 to 30 months of age in infants born after a threatened preterm labour.
Andreu, J.; (...); Garcia-Blanco, A.
Meeting Abstract. 10.1192/j.eurpsy.2024.741. 2024
Predictors of postpartum depression in threatened preterm labour: Importance of psychosocial factors
Buesaa, Julia; (...); Garcia-Blanco, Ana
Article. 10.1016/j.sjpmh.2023.06.004. 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
Rescue doses of antenatal corticosteroids, childrens neurodevelopment, and salivary cortisol after a threatened preterm labor: A 30-month follow-up study.
Navalon, Pablo; (...); Garcia-Blanco, Ana
Article. 10.1016/j.ajogmf.2023.100918. 2023
Spanish validation of the Empirically Developed Clinical Staging Model (EmDe-5) for patients with bipolar disorder.
de la Fuente-Tomas, Lorena; (...); Garcia-Portilla, Maria Paz
Article. 10.1016/j.rpsm.2021.09.005. 2023
Study protocol: Epigenetic variations associated to the conversion of schizophrenia in ultra-high risk adolescents, a 4-year follow-up study
Navalon, P., Canada, Y., Garcia-Blanco, A.
Meeting Abstract. 10.1192/j.eurpsy.2023.1320. 2023
Temperamental and psychomotor predictors of ADHD symptoms in children born after a threatened preterm labour: a 6-year follow-up study
Navalón P; (...); García-Blanco A
Article. 10.1007/s00787-022-02073-9. 2022
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 effects of reward and frustration on the task performance of autistic children and adolescents.
Ghosn, Farah; (...); Garcia-Blanco, Ana
Article. 10.1016/j.ridd.2023.104567. 2023
The impact of maternal psychopathology on psychomotor development trajectories in infants born after a threatened preterm labour from 6 to 30 months of age
Andreu, J.; (...); Garcia-Blanco, A.
Meeting Abstract. 10.1192/j.eurpsy.2024.1692. 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
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
Understanding the course of Attention-Deficit/Hyperactivity Disorder in Children Born After a Suspected Preterm Labor: A 6-Year Cohort Study.
Buesa, Julia; (...); Garcia-Blanco, Ana
Article. 10.1016/j.ajogmf.2024.101289. 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