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

November 22, 2007 updated by: D-Pharm Ltd.

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

This study will examine if DP-b99 can improve neurological function (for example strength and coordination) in the 3 months after an acute stroke

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment

150

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 83 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Change in the National Institutes of Health Stroke Scale (NIHSS) score from baseline to Day 90

Secondary Outcome Measures

Outcome Measure
Safety and tolerability Neurological recovery and function

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

D-Pharm Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 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

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2005

Study Completion

October 1, 2006

Study Registration Dates

First Submitted

September 11, 2005

First Submitted That Met QC Criteria

September 11, 2005

First Posted (Estimate)

September 19, 2005

Study Record Updates

Last Update Posted (Estimate)

November 26, 2007

Last Update Submitted That Met QC Criteria

November 22, 2007

Last Verified

November 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ptcl-01213

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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