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APRIL :
APRIL : A double-blind, placebo-controlled, randomized, Phase Ib/IIa clinical study of ApTOLL for the treatment of acute ischemic stroke
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- Hernández-Jiménez, Macaarena (författare)
- AptaTargets SL,Spain
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- Abad-Santos, Francisco (författare)
- Universidad Autónoma de Madrid, Spain; Instituto de Salud Carlos III, Spain
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- Cotgreave, Ian (författare)
- RISE,Kemiska processer och läkemedel
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- Gallego, Jaime (författare)
- Neurological Center of Navarra, Spain
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- Jilma, Bernd (författare)
- Medical University of Vienna, Austria
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- Flores, Alan (författare)
- Hospital Joan XXIII, Spain
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- Jovin, Tudor (författare)
- Cooper Neurological Institute, USA
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- Vivancos, Jose (författare)
- Hospital La Princesa, Spain
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- Molina, Carlos (författare)
- Hospital Vall d'Hebron, Spain
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- Montaner, Joan (författare)
- Hospital Macarena, Spain
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- Casariego, Joaquin (författare)
- Aldebaran Health Intelligence SL, Spain
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- Dalsgaard, Mads (författare)
- Cureteq AG, Switzerland
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- Hernández-Pérez, Maria (författare)
- Hospital Germans Trias I Pujol, Spain
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- Liebeskind, David (författare)
- UCLA, USA
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- Cobo, Erik (författare)
- UPC Barcelona-Tech, Spain
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- Ribo, Marc (författare)
- AptaTargets SL,Spain; Hospital Vall d'Hebron, Spain
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(creator_code:org_t)
- 2023-02-24
- 2023
- Engelska.
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Ingår i: Frontiers in Neurology. - : Frontiers Media S.A.. - 1664-2295. ; 14
- Relaterad länk:
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https://doi.org/10.3...
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https://urn.kb.se/re...
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https://doi.org/10.3...
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Abstract
Ämnesord
Stäng
- 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 <6h window from symptoms onset to ApTOLL/placebo administration. The trial is currently being conducted and is divided into two parts: Phase Ib and Phase IIa. In Phase Ib, 32 patients will be allocated to four dose ascending levels to select, based on safety criteria, the best two doses to be administered in the following Phase IIa in which 119 patients will be randomized to three arms of treatment (dose A, dose B, and placebo).
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Neurologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Neurology (hsv//eng)
Nyckelord
- aptamer
- ApTOLL
- clinical trial
- inflammation
- neuroprotection
- stroke
- TLR4
Publikations- och innehållstyp
- ref (ämneskategori)
- art (ämneskategori)
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Hernández-Jiméne ...
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Abad-Santos, Fra ...
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Cotgreave, Ian
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Gallego, Jaime
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Jilma, Bernd
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Flores, Alan
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visa fler...
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Jovin, Tudor
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Vivancos, Jose
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Molina, Carlos
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Montaner, Joan
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Casariego, Joaqu ...
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Dalsgaard, Mads
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Hernández-Pérez, ...
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Liebeskind, Davi ...
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Cobo, Erik
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Ribo, Marc
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visa färre...
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