To assess the efficacy and safety of lubeluzole in the treatment of ischemic stroke.
- Lubeluzole (Prosynap®)Drug
Intervention Desc: Ion channel and nitric oxide blocker.
Multicenter, randomized, double-blind, placebo-controlled study involving 721 patients.
Patients were randomized to receive either lubeluzole (7.5 mg over 1 hour, followed by a continuous daily infusion of 10 mg for up to 5 days) or placebo. Study medication was administered until complete neurological recovery, as measured by a score of 0 on the NIHSS, or for a maximum of 5 days and 1 hour. Patients were evaluated for 12 weeks from the start of treatment.
|Type||Measure||Time Frame||Safety Issue|
|Primary||Mortality at 12 weeks.|
|Secondary||Neurological recovery (based on the National Institutes of Health Stroke Scale [NIHSS]), functional status (based on the Barthel Index), and level of disability (based on the Rankin Scale). Safety assessments included electrocardiographic monitoring, physical examination, vital signs, laboratory evaluation, and adverse events.|