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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00190047
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : November 26, 2007
Information provided by:
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

Condition or disease Intervention/treatment Phase
Brain Ischemia Stroke Cerebrovascular Disorders Drug: DP-b99 Phase 2

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

Study Type : Interventional  (Clinical Trial)
Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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
Study Start Date : February 2005
Study Completion Date : October 2006

Primary Outcome Measures :
  1. Change in the National Institutes of Health Stroke Scale (NIHSS) score from baseline to Day 90

Secondary Outcome Measures :
  1. Safety and tolerability Neurological recovery and function

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Patients that may enter the study:

  • Patients with ischemic stroke, (that is, stroke that results from a blockage of blood flow to part of the brain), which is accompanied by language dysfunction (e.g. inability to understand speech), visual field defect or inattention to one side of the body or the space around the patient.
  • Patients in whom the study treatment can start no less than 1 and not more than 9 hours after the stroke's onset
  • Patients with moderate-severe degree of neurological deficit in the 9 hours after stroke onset (defined as NIHSS score of 7 to 20
  • Patients that can understand the requirements of the study and are willing to provide written informed consent (If the subject is incapacitated, informed consent will be sought from a legally acceptable representative.)

Patients that cannot participate:

  • Patients with a brain (intracerebral or subarachnoid) hemorrhage per screening computed tomography scan candidates for thrombolytic therapy for the current stroke patients having a mental impairment that renders them incapable to understand the study's requirements patients with other diseases that in the investigator's opinion may lead, independently of the current stroke, to further deterioration in the subject's neurological status during the trial period, or may confuse the evaluation of the present stroke
  • Patients likely to undergo a procedure involving cardiopulmonary bypass during the study period
  • Patients with medical conditions that may not enable them to complete the study (e.g life-threatening diseases,)
  • Patients whose condition improves already during the screening period
  • Patients who already have functional limitations before the present study (retrospective Modified Rankin Scale score of >3)
  • Patients who suffered a stroke within the past 90 days that seems to have been in the same brain region as the current acute stroke
  • Patients with severe hypertension (systolic BP >210 mm Hg or diastolic BP >120 mm Hg) or hypotension (systolic BP <90 mm Hg), Patients with significant history of renal or liver disease(s) (serum creatinine of > 2.0 mg/dL; alanine aminotransferase, aspartate aminotransferase, or gamma-glutamyl transferase values of > threefold the upper normal limit)
  • Patients with a platelet count of <100,000/mm3
  • Female patients of childbearing potential who are not using adequate and effective birth control measures or who are pregnant or lactating (the screening evaluation of female subjects of childbearing potential will include a serum pregnancy test.)
  • Patients who are users of addictive agents, or alcoholics
  • Patients who have received an investigational drug within the 90 days before the present stroke or such that are past recipients of DP-b99

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00190047

Neurologische Klink GmbH der Rhoen-Klinikum AG
Bad Neustadt / Saale, Germany, 97616
Charité - Universitätsmedizin Berlin / Campus Charité Mitte, Klinik und Poliklinik für Neurologie
Berlin, Germany, 10117
Universitätsklinik Essen Klinik und Poliklinik für Neurologie
Essen, Germany, 45122
Neurologische Universitätsklinik Abteilung für Neurologie
Freiburg, Germany, 79106
Klinik und Poliklinik für Neurologie Klinikum der Universität zu Köln
Köln, Germany, 50931
Universitätsklinikum Leipzig Klinik und Poliklinik für Neurologie
Leipzig, Germany, 04103
Otto-von-Guericke-Universität Magdeburg Medizinische Fakultät, Klinik für Neurologie
Magdeburg, Germany, 39120
Johannes Gutenberg-Universität Mainz Neurologische Klinik
Mainz, Germany, 55101
Klinikum 1 Minden Neurologische Klinik
Minden, Germany, 32427
Städtisches Krankenhaus München-Harlaching Abteilung für Neurologie
München-Harlaching, Germany, 81545
Neurologische Klinik und Poliklinik Technische Universität München Klinikum rechts der Isar
München, Germany, 81675
Städtisches Krankenhaus München-Bogenhausen Abteilung für Neurologie und Klinische
München, Germany, 81925
Universitätsklinikum Münster Klinik und Poliklinik für Neurologie
Münster, Germany, 48129
Klinikum Osnabrück Abteilung Neurologie
Osnabrück, Germany, 49076
Knappschaftskrankenhaus Recklinghausen Klinik für Neurologie und Klinische Neurophysiologie
Recklinghausen, Germany, 45657
Universitätsklinikum Ulm Abteilung für Neurologie im RKU
Ulm, Germany, 89081
Medizinisches Zentrum Kreis Aachen gGmbH Klinik für Neurologie
Würselen-Bardenberg, Germany, 52146
Rambam Medical Center
Haifa, Israel, 31096
Wolfson Medical Center
Holon, Israel, 58220
Hadassah Ein Kerem Medical Center
Jerusalem, Israel, 91120
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel, 64239
Chaim Sheba Medical Center
Tel Hashomer, Israel, 52621
Sponsors and Collaborators
D-Pharm Ltd.
Study Director: Gilad Rosenberg, M.D. D-Pharm Ltd.

Publications of Results:
Oral Session on Acute stroke: treatment concepts, presented on Thursday, 31 May 2007 at the XVI. European Stroke Conference, Glasgow, United Kingdom, 29 May - 1 June 2007. The abstract can be found at: Identifier: NCT00190047     History of Changes
Other Study ID Numbers: Ptcl-01213
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: November 26, 2007
Last Verified: November 2007

Keywords provided by D-Pharm Ltd.:
Cerebral Ischemia
Ischemic Brain Injury
Brain Infarction
Brain Ischemia

Additional relevant MeSH terms:
Cerebrovascular Disorders
Brain Ischemia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes