A multicentric, randomized, double-blind, parallel, placebo-controlled phase III study to assess the safety and efficacy of sovateltide in patients with acute cerebral ischemic stroke.

Acute cerebral ischemic stroke

The primary efficacy endpoint of the study is the proportion of acute cerebral ischemic stroke patients having a good functional outcome with a modified Rankin Scale score of 0-2 on day 90 post-randomization.

The proportion of acute cerebral ischemic stroke patients having a good functional outcome with NIHSS score of <6 on day 90 post-randomization., The proportion of acute cerebral ischemic stroke patients having a good functional outcome with BI score of ≥90 on day 90 post-randomization., The proportion of acute cerebral ischemic stroke patients having an excellent functional outcome with a modified Rankin Scale score of 0-1 on day 90 post-randomization., Change in QoL as assessed by EuroQol EQ-5D-5L and by SS-QOL from baseline to days 30, 60, and 90 post-randomization., The proportion of patients with recurrent ischemic stroke within 90 days post-randomization., Number of deaths within day 90 post-randomization., The proportion of patients with symptomatic ICH within 24 (± 6) hours of randomization., The proportion of patients with radiographic ICH within 24 (± 6) hours of randomization., Change in MoCA score at days 30 and 90 post-randomization., The proportion of patients with adverse events (AEs) and serious adverse events (SAEs).

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Germany, Spain