NCT00893867

Efficacy and Safety Study of DP-b99 in Treating Acute Ischemic Stroke

A Double Blind, Randomized, Placebo-controlled, Parallel Group, Multicenter Phase 3 Pivotal Study to Assess the Safety and Efficacy of 1mg/kg/Day Intravenous DP-b99 Over 4 Consecutive Days Versus Placebo When Initiated Within Nine Hours of Acute Ischemic Stroke Onset

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 446 (actual)
• Sponsor: D-Pharm Ltd. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this trial is to determine if intravenous administration of the metal ion trapping agent DP-b99 up to 9 hours following acute ischemic stroke onset, and then for 3 additional days (4 consecutive days in total) is effective in improving long term outcome. Patients will be followed up for 3 months after the stroke.

Detailed description

This will be a randomized, double-blind, placebo-controlled, multicenter, multi-national, parallel-arm, pivotal study comparing a placebo group to a DP-b99 group treated with intravenous 1.0 mg/kg/d for 4 consecutive days, in acute ischemic stroke patients with an entry National Institutes of Health Stroke Scale (NIHSS) score of 10-16 and a clinical syndrome that includes at least 1 of the following: language dysfunction, visual field defect or Extinction and Inattention (formerly Neglect) (as reflected by at least 1 point on any of the corresponding items of the NIHSS: 9, 3 or 11). An interim analysis for futility will be performed after Day 90 (or last available observation) primary endpoint data have been collected on about 45% of subjects planned to be enrolled. Clinical trial material (CTM) will be administered within 9 hours after the onset of acute ischemic stroke symptoms. Subjects will be randomized at a ratio of 1:1 to receive either DP-b99 or placebo. A data and safety monitoring board (DSMB) will assess the accumulating safety data periodically and will oversee the interim futility analysis.

Conditions

• Acute Ischemic Stroke

Interventions

Type	Name	Description
DRUG	DP-b99	1mg/kg/day over 4 consecutive days given intravenously and initiated up to 9 hours following acute stroke onset.
DRUG	Placebo	1mg/kg/day over 4 consecutive days given intravenously and initiated up to 9 hours following acute stroke onset.

Timeline

• Start date: 2009-12-01
• Primary completion: 2012-04-01
• Completion: 2012-04-01
• First posted: 2009-05-06
• Last updated: 2012-10-24

Locations

154 sites across 18 countries: United States, Austria, Brazil, Canada, Czechia, France, Germany, Hungary, Israel, Italy, Netherlands, Poland, Portugal, Slovakia, South Africa, South Korea, Spain, Switzerland