A Study to Evaluate the Effects of YM872 on Brain Function and Disability When Administered in Combination With Alteplase (Tissue Plasminogen Activator)

Completed

Phase 2 Results

Trial Description

The purpose of this study is to determine if YM872 in combination with t-PA can reduce disability and brain damage from stroke. YM872 or placebo will be given as a continuous intravenous (iv) infusion for 24 hours. It is important that the study medication, YM872 or placebo, is administered prior to the completion of the t-PA administration. The clinical effects of YM872 in addition to t-PA will be determined by assessing 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

Eligible patients will be randomized to receive a either a 24-hour infusion of YM872 or of placebo. All patients will receive standard infusions of tPA within 3 hours of stroke onset, and will be followed-up at 90 days.

Outcomes

Type Measure Time Frame Safety Issue
Primary Efficacy will be measured using neurological function and disability scales.

Sponsors