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 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.
Trial Stopped: The result of a pre-planned interim futility analysis
- DP-b99 Drug
Intervention Desc: 1mg/kg/day over 4 consecutive days given intravenously and initiated up to 9 hours following acute stroke onset. ARM 1: Kind: Experimental Label: DP-b99
- Placebo Drug
Intervention Desc: 1mg/kg/day over 4 consecutive days given intravenously and initiated up to 9 hours following acute stroke onset. ARM 1: Kind: Experimental Label: Mannitol
- Allocation: Randomized
- Masking: Double Blind (Subject, Caregiver, Investigator)
- Purpose: Treatment
- Endpoint: Safety/Efficacy Study
- Intervention: Parallel Assignment
Patient will have a base line MRI or CT confirming diagnosis.Will have baseline mRS and NIHSS testing and repeated at 3 months.
|Type||Measure||Time Frame||Safety Issue|
|Primary||Modified Rankin Scale (mRS) categorical analysis (“shift”) after 90 days.|
|Secondary||Recovery, defined as a score of ? 1 on mRS Recovery, defined as a score of ? 1 on NIHSS.|
|Primary||Modified Rankin Scale (mRS) categorical analysis ("shift")||90 days||No|
|Secondary||Recovery, defined as a score of ≤ 1 on mRS Recovery, defined as a score of ≤ 1 on NIHSS.||90 days||No|
|Secondary||Safety and tolerability||throughout study - baseline until day 90||Yes|
|Secondary||Recovery, defined as a score of ≤ 1 on modified Rankin Score||90 days||No|
|Secondary||recovery as assessed by an NIHSS of not more than 1||90 days||No|
|Secondary||'home time'||90 days||No|
- D-Pharm Ltd. Lead