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

Terminated

Phase 3 Results N/A

Trial Description

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.

Trial Stopped: The result of a pre-planned interim futility analysis

Conditions

Interventions

  • 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

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Patient Involvement

Patient will have a base line MRI or CT confirming diagnosis.Will have baseline mRS and NIHSS testing and repeated at 3 months.

Outcomes

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

Sponsors