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.

Trial status: Authorised 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). 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).

Age group: 18-64 years, 65+ years Gender: Female, Male Target enrollment: 262 participants