A Study to Evaluate the Effects of YM872 on Stroke Lesion Volume in Acute Stroke Patients

Completed

Phase 2 Results

Trial Description

This study will investigate the effects of a potential neuroprotectant compound, YM872, in the treatment of acute ischemic stroke. The study will determine if a 24-hour infusion of YM872, given within 6 hours of stroke onset, reduces the ischemic lesion volume as measured by MRI at 28 days after the infusion is given. The clinical effects of YM872 will also be determined by neurological function and disability scores at follow up visits through Day 90 of the study.

Conditions

Interventions

Trial Design

  • Allocation: Randomized
  • Masking: Double-Blind
  • Purpose: Treatment

Patient Involvement

All patients were given a baseline neurological exam and MRI to assess eligibility. Patients who fulfilled the inclusion criteria were randomized to receive either a 24-hour continuous intravenous infusion of YM872 or an identically delivered infusion of placebo. All patients were monitored in the NNICU during the treatment, and received a follow-up MRI on day 28 and a clinical evaluation on day 90.

Outcomes

Type Measure Time Frame Safety Issue
Primary Lesion volume at day 28, as measured by T2- weighted MRI with fluid- attenuated inversion recovery (FLAIR) sequencing; clinical outcomes at day 90.

Sponsors