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

Status:	Archived
Conditions:	Peripheral Vascular Disease, Neurology
Therapuetic Areas:	Cardiology / Vascular Diseases, Neurology
Healthy:	No
Age Range:	Any
Updated:	7/1/2011
Start Date:	December 2009
End Date:	June 2012

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

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.

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 50% of subjects planned to be enrolled. Enrollment will be stratified on a
one to one basis into two time-to-treatment tiers: 0- 4.5 hours, and >4.5 - 9 hours after
stroke onset. 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.

We found this trial at

sites

Tufts Clinical Pharmacology Study Unit

Boston, Massachusetts 02111