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

NCT00190047 | Completed Phase 2

• 1 other identifier: Ptcl-01213
• Study Type: interventional
• Target: 150
• Locations: 2 countries
• Sites: 22

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

Conditions

Brain Ischemia; Stroke; Cerebrovascular Disorders

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

• Safety and tolerability Neurological recovery and function

Interventions

DP-b99 DRUG

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• D-Pharm Ltd.: lead

Study Sites (22)

Neurologische Klink GmbH der Rhoen-Klinikum AG

Bad Neustadt / Saale, 97616, Germany

Location

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

Berlin, 10117, Germany

Location

Klinik und Poliklinik für Neurologie Klinikum der Universität zu Köln

Cologne, 50931, Germany

Location

Universitätsklinik Essen Klinik und Poliklinik für Neurologie

Essen, 45122, Germany

Location

Neurologische Universitätsklinik Abteilung für Neurologie

Freiburg im Breisgau, 79106, Germany

Location

Universitätsklinikum Leipzig Klinik und Poliklinik für Neurologie

Leipzig, 04103, Germany

Location

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

Magdeburg, 39120, Germany

Location

Johannes Gutenberg-Universität Mainz Neurologische Klinik

Mainz, 55101, Germany

Location

Klinikum 1 Minden Neurologische Klinik

Minden, 32427, Germany

Location

Neurologische Klinik und Poliklinik Technische Universität München Klinikum rechts der Isar

München, 81675, Germany

Location

Städtisches Krankenhaus München-Bogenhausen Abteilung für Neurologie und Klinische

München, 81925, Germany

Location

Städtisches Krankenhaus München-Harlaching Abteilung für Neurologie

München-Harlaching, 81545, Germany

Location

Universitätsklinikum Münster Klinik und Poliklinik für Neurologie

Münster, 48129, Germany

Location

Klinikum Osnabrück Abteilung Neurologie

Osnabrück, 49076, Germany

Location

Knappschaftskrankenhaus Recklinghausen Klinik für Neurologie und Klinische Neurophysiologie

Recklinghausen, 45657, Germany

Location

Universitätsklinikum Ulm Abteilung für Neurologie im RKU

Ulm, 89081, Germany

Location

Medizinisches Zentrum Kreis Aachen gGmbH Klinik für Neurologie

Würselen-Bardenberg, 52146, Germany

Location

Rambam Medical Center

Haifa, 31096, Israel

Location

Wolfson Medical Center

Holon, 58220, Israel

Location

Hadassah Ein Kerem Medical Center

Jerusalem, 91120, Israel

Location

Tel Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

Chaim Sheba Medical Center

Tel Litwinsky, 52621, Israel

Location

Related 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

  RESULT

Related Links

• Click here for more information on the sponsor

MeSH Terms

Conditions

Brain Ischemia; Stroke; Cerebrovascular Disorders; Brain Infarction

Interventions

DP-b99

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Gilad Rosenberg, M.D.

  D-Pharm Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 11, 2005
• First Posted: September 19, 2005
• Study Start: February 1, 2005
• Study Completion: October 1, 2006
• Last Updated: November 26, 2007

Record last verified: 2007-11

Locations

DE (17); IL (5)