RESCUE: A Randomized, Blinded, Placebo-controlled, Parallel Group Study Design to Determine the Safety of RNS60 in Large Vessel Occlusion Stroke Patients Undergoing Endovascular Thrombectomy (P10-5.029)

摘要: Objective Despite significant improvements in early reperfusion therapy, there remains a need for cerebro-protective therapies to enhance the brain’s resilience to and recovery from a stroke. Background RNS60 is an experimental neuroprotective drug that showed significant promise in rodent and primate models of stroke. RESCUE is a proof-of-concept trial to test RNS60 treatment in patients with large vessel occlusion and acute ischemic stroke. Design/Methods We utilized a multicenter, placebo controlled, blinded Phase 2 study design in participants with large vessel occlusion who are eligible for endovascular thrombectomy. The study includes participants with an NIHSS score> 5, ASPECTS> 5, evidenced presence of penumbra/collaterals, and pre-stroke mRS score≤ 2. Participants received a 48-h infusion of 0.5 mL/kg/h RNS60, 1 mL/kg/h RNS60, or 1 mL/kg/h placebo starting prior to arterial access closure …