Effects Of DP-b99 On Neurological Function In Subjects With Acute Ischemic Hemispheric Stroke

Completed

Phase 2 Results

Trial Description

This study will examine if DP-b99 can improve neurological function (for example strength and coordination) in the 3 months after an acute stroke

Detailed Description

The study will include a Screening/Baseline Period, a Treatment Period, and a Post-treatment Follow-up Period. During the Screening Period, subjects will be selected for the study on the basis of inclusion and exclusion criteria (see below). A screening computed tomography scan to exclude brain bleeding will be performed. The patient's informed consent will be obtained. The patient will be randomly allocated to DP-b99 or placebo. Immediately after this randomization and baseline assessments (lab tests and ECG), subjects will be given a 2-hour intra-venous infusion of DP-b99 or placebo. Additional 3 such infusions will then be given daily to a total of 4 consecutive treatment days, which make up the "Treatment Period". Throughout the 4-day Treatment Period the treatment's safety and the National Institutes of Health Stroke Scale (NIHSS) score will be evaluated daily. (The NIHSS assesses certain abilities of the patient, e.g. strength, speech, vision and coordination). If their condition requires, patients may have to stay in hospital more than these 4 days, regardless of their participation in the study.Subjects will be further assessed for NIHSS score changes and safety (lab tests and ECG) during the Post-treatment Follow-up Period, with data collected 30 and 90 days after the stroke. Other outcome scales (Barthel Index and Modified Rankin Scale) will be also used in the Day 30 and Day 90 visits

Conditions

Interventions

Trial Design

  • Allocation: Randomized
  • Masking: Double-Blind
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Patient Involvement

Patients will be screened by tomography to exclude brain bleeding, and eligible patients will then be randomized into the DP-b99 and placebo treatment groups. All patients will be given a 2-hour intra-venous infusion of DP-b99 or placebo, with an additional 3 such infusions given daily to a total of 4 consecutive treatment days. During this period, patients will be evaluated daily with the NIHSS. Further assessments will be made of the patients 30 and then 90 days after treatment, and will also include the Barthel Index and Modified Rankin Scale.

Outcomes

Type Measure Time Frame Safety Issue
Primary The primary endpoint is change in NIHSS score from baseline to day 90.
Secondary Safety and tolerability and neurological recovery and function.
Primary Change in the National Institutes of Health Stroke Scale (NIHSS) score from baseline to Day 90
Secondary Safety and tolerability Neurological recovery and function

Sponsors