US and Canadian Lubeluzole Ischemic Stroke Study "Lub"

Completed

Phase 3 Results

Trial Description

To assess the efficacy and safety of lubeluzole in the treatment of ischemic stroke.

Interventions

  • Lubeluzole (Prosynap┬«)Drug
    Intervention Desc: Ion channel and nitric oxide blocker.

Trial Design

Multicenter, randomized, double-blind, placebo-controlled study involving 721 patients.

Patient Involvement

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.

Outcomes

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.

Sponsors

Janssen Research Foundation, Beerse, Belgium