Efficacy and Safety Study of DP-b99 in Treating Acute Ischemic Stroke
NCT ID: NCT00893867
Last Updated: 2012-10-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
446 participants
INTERVENTIONAL
2009-12-31
2012-04-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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DP-b99
DP-b99
1mg/kg/day over 4 consecutive days given intravenously and initiated up to 9 hours following acute stroke onset.
Mannitol
Placebo
1mg/kg/day over 4 consecutive days given intravenously and initiated up to 9 hours following acute stroke onset.
Interventions
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DP-b99
1mg/kg/day over 4 consecutive days given intravenously and initiated up to 9 hours following acute stroke onset.
Placebo
1mg/kg/day over 4 consecutive days given intravenously and initiated up to 9 hours following acute stroke onset.
Eligibility Criteria
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Inclusion Criteria
2. Suffered an acute, likely hemispheric, ischemic stroke, defined as acute, focal, neurological deficit(s), secondary to a presumed vascular event, which must include at least one of the following components (as reflected by at least 1 point on any of the corresponding items of the NIHSS: 3, 9 or 11):
* Visual
* Best Language
* Extinction and Inattention (formerly Neglect)
3. Suffered the onset of an acute ischemic stroke that can be evaluated and treatment initiated within 9 hours after the onset of acute ischemic stroke symptoms.
4. Screening NIHSS score of 10 to 16, inclusive
5. Readily accessible peripheral venous access for clinical trial material (CTM) administration and blood sampling
6. Ability to understand the requirements of the study and be willing to provide written informed consent as evidenced by signature on an informed consent document approved by an institutional review board or independent ethics committee, and agree to abide by the study restrictions and return for the required assessments.
7. Provided written authorization for use and disclosure of protected health information in accordance with the Health Insurance Portability and Accountability Act in the United States and the Personal Information Protection and Electronic Documents Act in Canada
Exclusion Criteria
2. A candidate for either:
1. thrombolytic therapy, or have been treated with thrombolytic therapy for the current stroke
2. mechanical thromboembolectomy, or have been treated with mechanical thromboembolectomy for the current stroke
3. Delirious, comatose or stuporous or demented, or having a mental impairment that in the investigator's opinion renders the subject incapable to participate in the study
4. Have seizure(s) anytime from stroke onset to screening/baseline NIHSS evaluation
5. Neurological or non-neurological comorbidities that in the investigator's opinion may lead, independent of the current stroke, to further deterioration in the subject's neurological status during the trial period, or may render the study's neurological assessments inconclusive for the purpose of evaluating solely the stroke's effects
6. Likely to undergo a procedure involving cardiopulmonary bypass during the study period
7. Suffered a myocardial infarction in the last 90 days
8. Any medical condition that in the investigator's opinion may threaten the subject's ability to complete the study (e.g., concurrent significant or life-threatening diseases, such as malignancies or end stage organ failure)
9. Rapid spontaneous improvement of neurological signs during screening/baseline assessments
10. Premorbid neurological deficits and functional limitations assessed by a pre-stroke Modified Rankin Scale score of \> 1
11. Suffered a stroke within 90 days of the screening/baseline assessments that is either diagnostically confirmed or assumed to be in the same cerebral territory as is the current acute stroke
12. Either severe hypertension or hypotension, as measured by at least 2 consecutive supine measurements taken 10 minutes apart prior to randomization.
13. Significant current renal or hepatic disease(s): a serum creatinine concentration of \>2.5 mg/dL; alanine aminotransferase, aspartate aminotransferase, or gamma-glutamyl transferase values that are three times greater than the upper limit of normal.
14. Have a platelet count of \<100,000/mm3 or, for patients on oral anticoagulants at study entry, INR of \>4
15. Female of childbearing potential who is not willing to use adequate and effective birth control measures for the duration of the trial. Effective birth control measures include hormonal contraception, a barrier method such as a diaphragm, intrauterine device and/or condom with spermicide
16. Positive urine pregnancy test at screening/baseline or be a lactating female
17. Currently dependent on, or abusing, alcohol or one or more of the following: sympathomimetic amines, cannabis, cocaine, hallucinogens, inhalants, opioids, phencyclidine, sedatives and hypnotics
18. Received an investigational drug or product or participated in an investigational drug study within a period of 30 days prior to receiving study medication or have previously participated in a clinical trial involving DP-b99
19. Severe anemia as measured by a hemoglobin value of \< 7 g/dl.
20. In a dependent relationship with the physician or the study sponsor.
21. Known hypersensitivity to any component of the investigational product.
18 Years
85 Years
ALL
No
Sponsors
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D-Pharm Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Ashfaq Shuaib, MD
Role: PRINCIPAL_INVESTIGATOR
University of Alberta Hospital, Edmonton, Canada
Vasco Salgado, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital Professor Doutor Fernando Fonseca, EPE, Amadora, Portugal
Philippe Lyrer, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Universitätsspital Basel, Neurologie, Basel, Switzerland
Tobien Schreuder, MD
Role: PRINCIPAL_INVESTIGATOR
Atrium MC Parkstad, Heerlen, Netherlands
Maria S Rocha, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital Santa Marcelina, Sao Paulo, Brasil
Hugues Chabriat, Prof.
Role: PRINCIPAL_INVESTIGATOR
Hôpital Lariboisière - Service Neurologie, Paris, France
Locations
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University Hospital Nitra
Nitra, , Slovakia
Hospital un Poliklinic
Spišská Nová Ves, , Slovakia
Faculty Hospital Trnava
Trnava, , Slovakia
Research Center of Southern California
Oceanside, California, United States
Associated Neurologists, P.C.
Danbury, Connecticut, United States
Memorial Health University Medical Center
Savannah, Georgia, United States
The University of Kentucky The Methodist Hospital
Lexington, Kentucky, United States
University of Louisville, Kentucky Neuroscience Research
Louisville, Kentucky, United States
Tufts Medical Center
Boston, Massachusetts, United States
Capital Health Regional Medical Center Neuroscience Institute
Trenton, New Jersey, United States
Presbitarian Hospital
Charlotte, North Carolina, United States
St. Elizabeth's Medical Center
Youngstown, Ohio, United States
Legacy Meridian Park Medical Center
Tualatin, Oregon, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
The Methodist Hospital
Houston, Texas, United States
Carilion Clinic
Roanoke, Virginia, United States
Medizinische Universität Innsbruck
Innsbruck, , Austria
Landeskrankenhaus Klagenfurt
Klagenfurt, , Austria
Abt. Neurologie und Psychiatrie
Linz, , Austria
LKH St. Pölten Department of Neurology
Sankt Pölten, , Austria
Santa Casa de Misericordia de Belo Horizonte Departamento de Neurologia
Belo Horizonte, , Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre, , Brazil
Hospital Moinhos de Vento
Porto Alegre, , Brazil
Hospital Mãe de Deus
Porto Alegre, , Brazil
Santa Casa de Misericórdia de Porto Alegre Policlinica Santa Clara Sala de Neurologia
Porto Alegre, , Brazil
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto Unidade de Emergência Centro de Estudos
Ribeirão Preto, , Brazil
Hospital São José de Joinville
Santa Catarina, , Brazil
Hospital Santa Marcelina
São Paulo, , Brazil
UNIFESP
São Paulo, , Brazil
Hamilton Health Sciences Centre
Hamilton, Ontario, Canada
Grey Nun's Community Hospital
Edmonton, , Canada
University of Alberta Hospital
Edmonton, , Canada
Hamilton Health Sciences Centre
Hamilton, , Canada
Kingston General Hospital
Kingston, , Canada
Chinook Regional Hospital
Lethbridge, , Canada
CHA- Hôpital de l'Enfant-Jésus
Québec, , Canada
University Hospital Brno
Brno, , Czechia
University Hospital Hradec Kralove, Clinic of Neurology
Hradec Králové, , Czechia
Hospital Jihlava Clinic of Neurology
Jihlava, , Czechia
Hospital Vítkovice Clinic of Neurology
Ostrava, , Czechia
County Hospital Pardubice Clinic of Neurology
Pardubice, , Czechia
Clinic of Neurology, Stroke Center, Charles University
Prague, , Czechia
University Hospital Kralovske Vinohrady
Prague, , Czechia
University Hospital Motol Clinic of Neurology
Prague, , Czechia
CHU Jean Minjoz Besançon
Besançon, , France
Hopital Pellegrin-Tripode
Bordeaux, , France
CHU Henri Mondor
Créteil, , France
Hopital Gui de Chauliac
Montpellier, , France
Hôpital Bichat
Paris, , France
Hôpital Lariboisière - Service Neurologie
Paris, , France
Hôpital Saint Jean
Perpignan, , France
Ärztlicher Direktor Neurologische Klinik, Neurologische Klink GmbH der Rhoen-Klinikum AG
Bad Neustadt / Saale, , Germany
Marien-Krankenhaus gGmbH, Abteilung für Neurologie
Bergisch Gladbach, , Germany
DRK Kliniken Berlin, Klinik fuer Neurologie
Berlin, , Germany
Vivantes Klinikum Neukölln, Klinik für Neurologie, Stroke Unit
Berlin, , Germany
Klinikum Bremen-Mitte
Bremen, , Germany
Klinikum Bremerhaven-Reinkenheide gGmbH, Neurologische Klinik
Bremerhaven, , Germany
Klinikum Chemnitz GmbH Chefarzt Klinik für Neurologie
Chemnitz, , Germany
Klinikum Köln Merheim, Department of Neurology
Cologne, , Germany
Helios Klinikum Erfurt GmbH
Erfurt, , Germany
Universitätsklinikum Erlangen, Neurologische klinik
Erlangen, , Germany
Universitätsklinikum Essen, Klinik und Poliklinik für Neurologie
Essen, , Germany
Neurologische Universitätsklinik Freiburg, Neurozentrum
Freiburg im Breisgau, , Germany
Klinikum Fulda, Neurologische Klinik
Fulda, , Germany
Evangelische Kliniken Gelsenkirchen GmbH Klinik für Neurologie und Klinische Neurophysiologie
Gelsenkirchen, , Germany
Georg-August-Universitat Gottingen Neurologische Klinik
Göttingen, , Germany
Ernst Moritz Arndt University
Grifswald, , Germany
Askepios Klinik Altona
Hamburg, , Germany
Askepios Klinik Heidberg
Hamburg, , Germany
Universitätsklinikum Leipzig AöR, Klinik und Poliklinik für Neurologie
Leipzig, , Germany
Klinikum der Otto-von-Guericke-Universität Magdeburg, Neurologische Universitätsklinik
Magdeburg, , Germany
Johannes Gutenberg Universitat, Klinik und Poliklinik fur Neurologie
Mainz, , Germany
Klinikum 1 Minden, Neurologische Klinik
Minden, , Germany
Universität Rostock Chefarzt Abteilung Neurologie
Rostock, , Germany
ASKLEPIOS Fachklinikum Teupitz
Teupitz, , Germany
Krankenhaus der Bramherzigen Brüder
Trier, , Germany
Universitätsklinikum Ulm, Abteilung für Neurologie im RKU
Ulm, , Germany
Heinrich Braun Klinikum Zwickau
Zwickau, , Germany
Fővárosi Önkormányzat Péterfy Sándor utcai Kórház- Rendelőintézet és Baleseti Központ
Budapest, , Hungary
Állami Egészségügyi Központ
Budapest, , Hungary
Kenezy Korhaz Rendelointezet Egezsegugyi Szolgaltato Nonprofit Kft.
Debrecen, , Hungary
University of Debrecen, Medical and Health Science Center
Debrecen, , Hungary
Aladár Petz County Teaching Hospital
Győr, , Hungary
PM Flór Ferenc County Hospital
Kistarcsa, , Hungary
Borsod-Abaúj-Zemplén County Hospital Miskolc
Miskolc, , Hungary
Pécsi Tudományegyetem Klinikai Központ
Pécs, , Hungary
Zala Megyei Kórház
Zalaegerszeg, , Hungary
Bnai Zion Medical Center
Haifa, , Israel
Neurological Dept. Edith Wolfson Medical Center
Holon, , Israel
Meir Medical Center
Kfar Saba, , Israel
Sourasky Medical Center
Tel Aviv, , Israel
Chaim Sheba Medical Center
Tel Litwinsky, , Israel
Ospedale Regionale Valle d'Aosta
Aosta, , Italy
Dipartimento di Neuroscienze, Ospedale di Brotzu
Cagliari, , Italy
Ospedale di Circolo di Varese
Lombardia, , Italy
Istituto Scientifico San Raffaele - Stroke Unit
Milan, , Italy
Istituto Neurologico C. Mondino
Pavia, , Italy
Università di Perugia, Division of Internal and Cardiovascular Medicine - Stroke Unit
Perugia, , Italy
Presidio Ospedaliero di Piacenza
Piacenza, , Italy
Azienda Ospedaliera Sant'Andrea, Stroke Unit
Rome, , Italy
Istituto Patologia Generale U.C.S.C
Rome, , Italy
U.O.C. Stroke Unit
Rome, , Italy
Università di Roma "La Sapienza" - Stroke Unit
Rome, , Italy
Azienda Ospedaliera Universitaria "Santa Maria della Misericordia" Stroke Unit
Udine, , Italy
Catharina Ziekenhuis Neurologie
Eindhoven, , Netherlands
Medisch Spectrum Twente Hoofd Afdeling Vasculaire Neurologie
Enschede, , Netherlands
Atrium MC Parkstad
Heerlen, , Netherlands
Isala Klinieken Ploikliniek Neurologie
Zwolle, , Netherlands
Pomerania Traumatology Center, Regional Specialist Hospital im. Nicolaus Copernicus
Gdansk, , Poland
Medical University of Lublin, Department of Neurology, Stroke Unit
Lublin, , Poland
Samodzielny Publiczny Zespol Zakladow Opieki Zdrowotnej w Sandomierzu
Sandomierz, , Poland
Szpital Powiatowy im. Marii Curie - Skłodowskiej w Skarżysku-Kamiennej
Skarżysko-Kamienna, , Poland
Wojewodzki Szpital Specjalistyczny Nr 1 im. Prof. Jozefa Gasinskiego
Tychy, , Poland
Instytut Psychiatrii i Neurologii Oddział Neurologiczny z Pododdziałem Udarowym
Warsaw, , Poland
Medical University of Warsaw, Department of Neurology
Warsaw, , Poland
Szpital Wolski im. dr Anny Gostyńskiej Samodzielny Publiczny Zakład Opieki Zdrowotnej, Oddział Neurologii
Warsaw, , Poland
Wojskowy Instytut Medyczny, Oddział Neurologii
Warsaw, , Poland
Hospital Professor Doutor Fernando Fonseca, EPE
Amadora, , Portugal
Centro Hospitalar de Coimbra EPE
Coimbra, , Portugal
Hospitais da Universidadde de Coimbra, EPE
Coimbra, , Portugal
Centro de Estudos Egas Moniz - Hospital de Santa Maria
Lisbon, , Portugal
Hospital de São Sebastião, EPE
Santa Maria da Feira, , Portugal
Neurology Clinic, Faculty Hospital in Martin
Martin, , Slovakia
Neurology dept.,Hospital Zilina
Žilina, , Slovakia
Fichmed
Bloemfontein, , South Africa
Constantiaberg Medi-clinic
Cape Town, , South Africa
Union Hospital
Gauteng, , South Africa
Helderberg Research Institute
Western Cape, , South Africa
Triervlei Trial Centre
Western Cape, , South Africa
Clinical Projects Research
Worcester, , South Africa
Dong-A Medical Center
Busan, , South Korea
Inje University BUSAN Paik Hospital
Busan, , South Korea
Inje University ILSAN Paik Hospital
Goyang, , South Korea
Chonnam National University Hospital
Gwangju, , South Korea
Inha University Hospital
Incheon, , South Korea
Seoul National University Bundang Hospital
Seongnam, , South Korea
ASAN Medical Center
Seoul, , South Korea
Severance Hospital
Seoul, , South Korea
The Catholic University of Korea Seoul St. Mary's hospital
Seoul, , South Korea
Hospital Universitario de Albacete
Albacete, , Spain
Hospital De La Santa Ta Creu i Sant Pau
Barcelona, , Spain
Hospital del Mar
Barcelona, , Spain
Hospital Germans Triasy Pujol
Barcelona, , Spain
Hospital Vall D'hebron
Barcelona, , Spain
Hospital Gregorio Maranon
Madrid, , Spain
Hospital La Princesa
Madrid, , Spain
Hospital Ramon y Cajal
Madrid, , Spain
Hospital Universitario Clinico San Carlos
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Clinico Universitario de Santiago
Santiago de Compostela, , Spain
Consorcio Hospital General Universitario Valencia
Valencia, , Spain
Hospital Clinico Universitario De Valladolid
Valladolid, , Spain
Universitätsspital Basel, Neurologie
Basel, , Switzerland
Universitätsspital Zürich, Klinik für Neurologie
Zurich, , Switzerland
Countries
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References
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Diener HC, Schneider D, Lampl Y, Bornstein NM, Kozak A, Rosenberg G. DP-b99, a membrane-activated metal ion chelator, as neuroprotective therapy in ischemic stroke. Stroke. 2008 Jun;39(6):1774-8. doi: 10.1161/STROKEAHA.107.506378. Epub 2008 Apr 10.
Rosenberg G, Angel I, Kozak A. Clinical pharmacology of DP-b99 in healthy volunteers: first administration to humans. Br J Clin Pharmacol. 2005 Jul;60(1):7-16. doi: 10.1111/j.1365-2125.2005.02378.x.
Barkalifa R, Hershfinkel M, Friedman JE, Kozak A, Sekler I. The lipophilic zinc chelator DP-b99 prevents zinc induced neuronal death. Eur J Pharmacol. 2009 Sep 15;618(1-3):15-21. doi: 10.1016/j.ejphar.2009.07.019. Epub 2009 Jul 19.
Rosenberg G, Bornstein N, Diener HC, Gorelick PB, Shuaib A, Lees K; MACSI investigators. The Membrane-Activated Chelator Stroke Intervention (MACSI) Trial of DP-b99 in acute ischemic stroke: a randomized, double-blind, placebo-controlled, multinational pivotal phase III study. Int J Stroke. 2011 Aug;6(4):362-7. doi: 10.1111/j.1747-4949.2011.00608.x. Epub 2011 Jun 6.
Rosenberg G, Marshall LS, Caraco Y. The neuroprotective agent DP-b99 does not interact with s-warfarin in vivo despite significant CYP2C9 inhibition in vitro. Basic Clin Pharmacol Toxicol. 2011 Apr;108(4):289-92. doi: 10.1111/j.1742-7843.2010.00654.x. Epub 2010 Dec 16. No abstract available.
Other Identifiers
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Ptcl-01373
Identifier Type: -
Identifier Source: org_study_id