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

NCT ID: NCT00190047

Last Updated: 2007-11-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-02-28
• Study Completion Date: 2006-10-31

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

Conditions

Brain Ischemia; Stroke; Cerebrovascular Disorders

Keywords

Cerebral Ischemia; Ischemic Brain Injury; Brain Infarction; Brain Ischemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

DP-b99

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

D-Pharm Ltd.

INDUSTRY

Sponsor Role: lead

Principal Investigators

Gilad Rosenberg, M.D.

Role: STUDY_DIRECTOR

D-Pharm Ltd.

Locations

Neurologische Klink GmbH der Rhoen-Klinikum AG

Bad Neustadt / Saale, , Germany

Charité - Universitätsmedizin Berlin / Campus Charité Mitte, Klinik und Poliklinik für Neurologie

Berlin, , Germany

Klinik und Poliklinik für Neurologie Klinikum der Universität zu Köln

Cologne, , Germany

Universitätsklinik Essen Klinik und Poliklinik für Neurologie

Essen, , Germany

Neurologische Universitätsklinik Abteilung für Neurologie

Freiburg im Breisgau, , Germany

Universitätsklinikum Leipzig Klinik und Poliklinik für Neurologie

Leipzig, , Germany

Otto-von-Guericke-Universität Magdeburg Medizinische Fakultät, Klinik für Neurologie

Magdeburg, , Germany

Johannes Gutenberg-Universität Mainz Neurologische Klinik

Mainz, , Germany

Klinikum 1 Minden Neurologische Klinik

Minden, , Germany

Neurologische Klinik und Poliklinik Technische Universität München Klinikum rechts der Isar

München, , Germany

Städtisches Krankenhaus München-Bogenhausen Abteilung für Neurologie und Klinische

München, , Germany

Städtisches Krankenhaus München-Harlaching Abteilung für Neurologie

München-Harlaching, , Germany

Universitätsklinikum Münster Klinik und Poliklinik für Neurologie

Münster, , Germany

Klinikum Osnabrück Abteilung Neurologie

Osnabrück, , Germany

Knappschaftskrankenhaus Recklinghausen Klinik für Neurologie und Klinische Neurophysiologie

Recklinghausen, , Germany

Universitätsklinikum Ulm Abteilung für Neurologie im RKU

Ulm, , Germany

Medizinisches Zentrum Kreis Aachen gGmbH Klinik für Neurologie

Würselen-Bardenberg, , Germany

Rambam Medical Center

Haifa, , Israel

Wolfson Medical Center

Holon, , Israel

Hadassah Ein Kerem Medical Center

Jerusalem, , Israel

Tel Aviv Sourasky Medical Center

Tel Aviv, , Israel

Chaim Sheba Medical Center

Tel Litwinsky, , Israel

Countries

Germany; Israel

References

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: http://www.esc-archive.eu/glasgow07/gla_so10_1.asp

Reference Type: RESULT

Related Links

http://www.dpharm.com

Click here for more information on the sponsor

Other Identifiers

Ptcl-01213

Identifier Type: -

Identifier Source: org_study_id