Effects Of DP-b99 On Neurological Function In Subjects With Acute Ischemic Hemispheric Stroke
- Conditions
- Brain IschemiaStrokeCerebrovascular Disorders
- Registration Number
- NCT00190047
- Lead Sponsor
- D-Pharm Ltd.
- Brief 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
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in the National Institutes of Health Stroke Scale (NIHSS) score from baseline to Day 90
- Secondary Outcome Measures
Name Time Method Safety and tolerability Neurological recovery and function
Trial Locations
- Locations (22)
Universitätsklinikum Ulm Abteilung für Neurologie im RKU
🇩🇪Ulm, Germany
Rambam Medical Center
🇮🇱Haifa, Israel
Neurologische Universitätsklinik Abteilung für Neurologie
🇩🇪Freiburg, Germany
Klinik und Poliklinik für Neurologie Klinikum der Universität zu Köln
🇩🇪Köln, Germany
Wolfson Medical Center
🇮🇱Holon, Israel
Klinikum Osnabrück Abteilung Neurologie
🇩🇪Osnabrück, Germany
Chaim Sheba Medical Center
🇮🇱Tel Hashomer, Israel
Klinikum 1 Minden Neurologische Klinik
🇩🇪Minden, Germany
Städtisches Krankenhaus München-Bogenhausen Abteilung für Neurologie und Klinische
🇩🇪München, Germany
Universitätsklinikum Münster Klinik und Poliklinik für Neurologie
🇩🇪Münster, Germany
Tel Aviv Sourasky Medical Center
🇮🇱Tel Aviv, Israel
Neurologische Klink GmbH der Rhoen-Klinikum AG
🇩🇪Bad Neustadt / Saale, Germany
Charité - Universitätsmedizin Berlin / Campus Charité Mitte, Klinik und Poliklinik für Neurologie
🇩🇪Berlin, Germany
Universitätsklinik Essen Klinik und Poliklinik für Neurologie
🇩🇪Essen, Germany
Otto-von-Guericke-Universität Magdeburg Medizinische Fakultät, Klinik für Neurologie
🇩🇪Magdeburg, Germany
Universitätsklinikum Leipzig Klinik und Poliklinik für Neurologie
🇩🇪Leipzig, Germany
Städtisches Krankenhaus München-Harlaching Abteilung für Neurologie
🇩🇪München-Harlaching, Germany
Neurologische Klinik und Poliklinik Technische Universität München Klinikum rechts der Isar
🇩🇪München, Germany
Johannes Gutenberg-Universität Mainz Neurologische Klinik
🇩🇪Mainz, Germany
Knappschaftskrankenhaus Recklinghausen Klinik für Neurologie und Klinische Neurophysiologie
🇩🇪Recklinghausen, Germany
Medizinisches Zentrum Kreis Aachen gGmbH Klinik für Neurologie
🇩🇪Würselen-Bardenberg, Germany
Hadassah Ein Kerem Medical Center
🇮🇱Jerusalem, Israel