1. APRIL: a double-blind, placebo-controlled, randomized, Phase Ib/IIa clinical study of ApTOLL for the treatment of acute ischemic stroke
- Author
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Hernández-Jiménez, Macarena, Abad-Santos, Francisco, Cotgreave, Ian, Gallego, Jaime, Jilma, Bernd, Flores, Alan, Jovin, Tudor G., Vivancos, José, Molina, Carlos A., Montaner, Joan, Casariego, Joaquín, Dalsgaard, Mads, Hernández-Pérez, María, Liebeskind, David S., Cobo, Erik, Ribo, Marc, Universitat Autònoma de Barcelona, Universitat Politècnica de Catalunya. Departament d'Estadística i Investigació Operativa, Universitat Politècnica de Catalunya. GRBIO - Grup de Recerca en Bioestadística i Bioinformàtica, Institut Català de la Salut, [Hernández-Jiménez M] AptaTargets S.L., Madrid, Spain. [Abad-Santos F] Clinical Pharmacology Department, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria La Princesa (IP), Universidad Autónoma de Madrid (UAM), Madrid, Spain. Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, Madrid, Spain. [Cotgreave I] Division of Bioeconomy and Health, Department of Chemical and Pharmaceutical Safety, Research Institutes of Sweden, Södertälje, Sweden. [Gallego J] Neurological Center of Navarra, Navarra, Spain. [Jilma B] Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria. [Flores A] Stroke Unit, Hospital Joan XXIII, Tarragona, Spain. [Molina CA] Unitat d’Ictus, Servei de Neurologia, Vall d'Hebron Hospital Universitari, Barcelona, Spain. [Ribo M] AptaTargets S.L., Madrid, Spain. Unitat d’Ictus, Servei de Neurologia, Vall d'Hebron Hospital Universitari, Barcelona, Spain, and Vall d'Hebron Barcelona Hospital Campus
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Inflammation ,ApTOLL ,Biomathematics ,Biomatemàtica ,Aptamer ,Malalties cerebrovasculars - Tractament ,92 Biology and other natural sciences::92B Mathematical biology in general [Classificació AMS] ,Otros calificadores::Otros calificadores::/farmacoterapia [Otros calificadores] ,Matemàtiques i estadística::Matemàtica aplicada a les ciències [Àrees temàtiques de la UPC] ,enfermedades del sistema nervioso::enfermedades del sistema nervioso central::enfermedades cerebrales::trastornos cerebrovasculares::accidente cerebrovascular [ENFERMEDADES] ,Other subheadings::Other subheadings::/drug therapy [Other subheadings] ,Neuroprotection ,Clinical trial ,Stroke ,Nervous System Diseases::Central Nervous System Diseases::Brain Diseases::Cerebrovascular Disorders::Stroke [DISEASES] ,técnicas de investigación::métodos epidemiológicos::diseño de la investigación epidemiológica::método doble ciego [TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS] ,Neurology ,TLR4 ,Neurology (clinical) ,Assaigs clínics ,Investigative Techniques::Epidemiologic Methods::Epidemiologic Research Design::Double-Blind Method [ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT] - Abstract
Inflammation; Neuroprotection; Stroke Inflamació; Neuroprotecció; Ictus Inflamación; Neuroprotección; Ictus In the reperfusion era, a new paradigm of treating patients with endovascular treatment (EVT) and neuroprotective drugs is emerging as a promising therapeutic option for patients with acute ischemic stroke (AIS). In this context, ApTOLL, a Toll-like receptor 4 (TLR4) antagonist with proven neuroprotective effect in preclinical models of stroke and a very good pharmacokinetic and safety profile in healthy volunteers, is a promising first-in-class aptamer with the potential to address this huge unmet need. This protocol establishes the clinical trial procedures to conduct a Phase Ib/IIa clinical study (APRIL) to assess ApTOLL tolerability, safety, pharmacokinetics, and biological effect in patients with AIS who are eligible for EVT. This will be a multicenter, double-blind, randomized, placebo-controlled, Phase Ib/IIa clinical study to evaluate the administration of ApTOLL together with EVT in patients with AIS. The study population will be composed of men and non-pregnant women with confirmed AIS with a
- Published
- 2023