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

Stroke Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00190047
• Other study ID #: Ptcl-01213
• Status: Completed
• Phase: Phase 2
• First received: September 11, 2005
• Last updated: November 22, 2007
• Start date: February 2005
• Est. completion date: October 2006

Study information

• Verified date: November 2007
• Source: D-Pharm Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesIsrael: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Ischemia
• Cerebrovascular Disorders
• Ischemia
• Stroke

Intervention

Drug:
• DP-b99

Locations

Country	Name	City	State
Germany	Neurologische Klink GmbH der Rhoen-Klinikum AG	Bad Neustadt / Saale
Germany	Charité - Universitätsmedizin Berlin / Campus Charité Mitte, Klinik und Poliklinik für Neurologie	Berlin
Germany	Universitätsklinik Essen Klinik und Poliklinik für Neurologie	Essen
Germany	Neurologische Universitätsklinik Abteilung für Neurologie	Freiburg
Germany	Klinik und Poliklinik für Neurologie Klinikum der Universität zu Köln	Köln
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
Israel	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 Hashomer

Sponsors (1)

Lead Sponsor	Collaborator
D-Pharm Ltd.

Countries where clinical trial is conducted

Germany,  Israel, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the National Institutes of Health Stroke Scale (NIHSS) score from baseline to Day 90
Secondary	Safety and tolerability Neurological recovery and function

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