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

This study has been completed.
Sponsor:
Information provided by:
D-Pharm Ltd.
ClinicalTrials.gov Identifier:
NCT00190047
First received: September 11, 2005
Last updated: November 22, 2007
Last verified: November 2007
  Purpose

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 Intervention Phase
Brain Ischemia
Stroke
Cerebrovascular Disorders
Drug: DP-b99
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Further study details as provided by D-Pharm Ltd.:

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

Secondary Outcome Measures:
  • Safety and tolerability Neurological recovery and function

Estimated Enrollment: 150
Study Start Date: February 2005
Estimated Study Completion Date: October 2006
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

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00190047

Locations
Germany
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-Bogenhausen Abteilung für Neurologie und Klinische
München, Germany, 81925
Neurologische Klinik und Poliklinik Technische Universität München Klinikum rechts der Isar
München, Germany, 81675
Städtisches Krankenhaus München-Harlaching Abteilung für Neurologie
München-Harlaching, Germany, 81545
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
Israel
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.
Investigators
Study Director: Gilad Rosenberg, M.D. D-Pharm Ltd.
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00190047     History of Changes
Other Study ID Numbers: Ptcl-01213
Study First Received: September 11, 2005
Last Updated: November 22, 2007
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Israel: Israeli Health Ministry Pharmaceutical Administration

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

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

ClinicalTrials.gov processed this record on October 19, 2014