Status:
COMPLETED
Effects Of DP-b99 On Neurological Function In Subjects With Acute Ischemic Hemispheric Stroke
Lead Sponsor:
D-Pharm Ltd.
Conditions:
Brain Ischemia
Stroke
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
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 incl...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
End Date :
October 1 2006
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00190047
Start Date
February 1 2005
End Date
October 1 2006
Last Update
November 26 2007
Active Locations (22)
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1
Neurologische Klink GmbH der Rhoen-Klinikum AG
Bad Neustadt / Saale, Germany, 97616
2
Charité - Universitätsmedizin Berlin / Campus Charité Mitte, Klinik und Poliklinik für Neurologie
Berlin, Germany, 10117
3
Klinik und Poliklinik für Neurologie Klinikum der Universität zu Köln
Cologne, Germany, 50931
4
Universitätsklinik Essen Klinik und Poliklinik für Neurologie
Essen, Germany, 45122