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

Stroke Clinical Trial

Official title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel Study To Evaluate The Effects Of DP-b99 On Neurologic Function And Disability In Subjects With Acute Ischemic Hemispheric Stroke

Status Completed

Clinical Trial Summary

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

Clinical Trial 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 ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Ischemia
• Cerebrovascular Disorders
• Ischemia
• Stroke

• NCT number: NCT00190047
• Study type: Interventional
• Source: D-Pharm Ltd.
• Status: Completed
• Phase: Phase 2
• Start date: February 2005
• Completion date: October 2006