Trial Condition(s):
Stroke, Acute Ischemic Stroke
Repinotan in Patients with Acute Ischemic Stroke
Bayer Identifier:
100282
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
The purpose of this trial is to evaluate Repinotan HCl in patients with acute ischemic stroke. At study entry patients will be randomized to Repinotan HCl or placebo in a 1:1 ratio. The total treatment period wil be 72 hours.
Inclusion Criteria
- Acute ischemic stroke of hemispheric localization (exclude brainstem and cerebellum), of suspected thromboembolic origin. - Males or females aged 18 years or over. - National Institute of Health Stroke Scale (NIH-SS) total score 8 to 23 with a motor deficit >/= 2 (for either one arm or leg) and level of consciousness < 2 and at least one of the following: Visual field deficit, neglect, or aphasia. If a patient receives t-PA, NIH-SS must be performed prior to receiving the study drug but after infusion of t-PA is initiated. - Signed informed consent from patient or legally authorized representative
Exclusion Criteria
- CT scan evidence of: - Clearly defined areas of hypodensity indicating infarction of >1/3 of the MCA territory or evidence of significant mass effect with shift of midline or major areas of sulcal effacement associated with loss of cortical definition (grey-white distinction). Minor early CT changes are common in MCA strokes and patients with early or subtle changes are eligible. - A primary intra-cerebral haemorrhage or any finding not consistent with an acute ischemic stroke as the cause of presenting symptoms. - Clinical evidence of acute stroke due to lacunar infarct (pure motor hemiplegia; pure sensory deficit, ataxia/clumsy hand syndromes)- Neurological (other than the presenting stroke) or psychiatric conditions that may affect the patient's functional status and/or that may interfere with the patient's assessment- Clinically relevant pre-existing neurological deficit (Historical Rankin score >/= 2 regardless of cause)- Generalized seizures having developed since the onset of stroke symptoms- Systolic blood pressure > 210 or < 110 mmHg (confirmed by up to three readings prior to randomization)- Diastolic blood pressure > 110 or < 60 mmHg (confirmed by up to three readings prior to randomization)- Myocardial infarction within 3 months, unstable angina within 3-5 days prior to starting infusion, unstable supra-ventricular and/or ventricular arrhythmia, severe conduction defect (AV block grades 2 and 3), complete left or right Bundle Branch Block, bradycardia (heart rate [HR] less than 50 bpm), uncompensated heart failure- History of myocarditis, cardiomyopathy or aortic stenosis- Patients known to have prolonged QTc intervals (inherited and sporadic syndromes of QTc prolongation or QTc interval > 450 msec males and 470 msec females on baseline ECG) or using Class IA or Class III antiarrhythmic drugs (e.g., quinidine, procainamide, amiodarone, sotalol)- Any patients that require initiation of new digoxin therapy are excluded. Patients already on digoxin therapy (for at least 1 month stable dose) at time of enrollment will be allowed in the study.- Electrolyte imbalance at baseline. Should the results not be available before starting the study drug infusion, the patients will be allowed in the study providing that the corrective therapy of any abnormal electrolyte results is implemented immediately upon availability of the laboratory report.- Any conditions predisposing to electrolyte imbalances (e.g., chronic vomiting, anorexia nervosa, bulimia nervosa) will also be excluded at baseline.- Participation in a research protocol for investigation of a pharmaceutical agent or innovative invasive procedure (including intra-arterial t-PA) within the past 30 days- Previously in the BRAIN-Study or treated with repinotan- Life expectancy of less than 6 months due to comorbid conditions- Any other known clinically significant medical disorder (e.g., cardiovascular, gastrointestinal, hepatic, renal, endocrine, major uncompensated metabolic disturbances, respiratory, immunological, hematological or bleeding disorder, cancer, AIDS)
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Royal Melbourne Hospital Melbourne, Australia, 3052 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hôpital Pellegrin Tripode - Bordeaux BORDEAUX, France, 33000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ninewells Hospital Dundee, United Kingdom, DD2 1UB | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Chaim Sheba Medical Center Tel Hashomer, Israel, 52621 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitair Medisch Centrum Groningen GRONINGEN, Netherlands, 9713 GZ | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Gosford Hospital Gosford, Australia, 2250 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sint-Jozefkliniek BORNEM, Belgium, 2880 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum Minden Minden, Germany, 32427 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital del Mar Barcelona, Spain, 08003 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Mikkelin keskussairaala Mikkeli, Finland, FIN-50100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Southern General Hospital Glasgow, United Kingdom, G51 4TG | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Tel Aviv Sourasky Medical Center Tel Aviv, Israel, 64239 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. Policlinico Umberto I Roma, Italy, 00155 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Donauklinikum- Standort Gugging Klosterneuburg, Austria, 3400 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Clínico Universitario de Santiago de Compostela Santiago de Compostela, Spain, 15706 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Borsod County Hospital Miskolc, Hungary, 3526 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsklinikum Charite zu Berlin Berlin, Germany, 10117 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations HUS, Meilahden sairaala Helsinki, Finland, 00290 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations IRCCS Ist Neurologico Mondino Pavia, Italy, 27100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Karolinska University Hospital Stockholm, Sweden, 171 76 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Landes-Nervenklinik Wagner-Jauregg Linz Linz, Austria, 4020 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Austin Repatriation Medical Centre, Austin Campus Melbourne, Australia, 3084 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universität Leipzig Leipzig, Germany, 04103 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Päijät-Hämeen keskussairaala Lahti, Finland, 15850 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hôpital Pasteur - Nice NICE, France, 06200 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Western Galille Hospital Nahariya Nahariya, Israel, 22100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Krankenhaus der Barmherzigen Brüder Wien, Austria, 1021 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ciutat Sanitària i Universitaria de la Vall d'Hebrón Barcelona, Spain, 08035 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations John Hunter Hospital New Lambton Heights, Australia, 2305 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum Großhadern der Ludwig-Maximilians-Universität München, Germany, 81377 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitair Medisch Centrum St. Radboud NIJMEGEN, Netherlands, 6525 GA | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations AULSS 06 Vicenza - Veneto Vicenza, Italy, 36100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Norrlands Universitetssjukhus Umeå, Sweden, 901 85 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations CU Saint-Luc/UZ St-Luc BRUXELLES - BRUSSEL, Belgium, 1200 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kuopion yliopistollinen sairaala Kuopio, Finland, 70120 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Leicester Royal Infirmary Leicester, United Kingdom, LE1 5WW | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Edith Wolfson Medical Center Holon, Israel, 58100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ospedale Borgo Trento Verona, Italy, 37126 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Bnai Zion Medical Center Haifa, Israel, 31048 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. di Reggio Emilia Reggio Emilia, Italy, 42100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ocala Neurodiagnostic Center Ocala, United States, 34471 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum der Eberhard-Karls-Universität Tübingen Tübingen, Germany, 72076 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Royal Hobart Hospital Hobart, Australia, 7000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Rambam Medical Center Haifa, Israel, 31096 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Policlinico Monteluce Perugia, Italy, 06126 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Western Medical Centre Melbourne, Australia, 3011 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum der Universität Regensburg Regensburg, Germany, 93053 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations The Alfred Hospital Melbourne, Australia, 3181 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Städ. Krankenhaus München-Harlaching München, Germany, 81545 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Clínico Universitario Lozano Blesa Zaragoza, Spain, 50009 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Rabin Medical Center, Campus Golda Petach Tikva, Israel, 49372 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. Osp San Carlo Borromeo Milano, Italy, 20153 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Office of Dr. Rodney D. Bell, MD Philadelphia, United States, 19107 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations AUSL 4 L'Aquila - Abruzzo L'Aquila, Italy, 67100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsklinikum Heidelberg Heidelberg, Germany, 69120 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Clínico Universitario de Valencia Valencia, Spain, 46010 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Friedrich-Alexander-Universität Erlangen-Nürnberg Erlangen, Germany, 91054 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Universitario "La Paz" Madrid, Spain, 28046 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations ASL 8 Vibo Valentia - Calabria Vibo Valentia, Italy, 89900 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Advanced Neurology Specialists Great Falls, United States, 59405 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Medizinische Einrichtungen der Universität Essen Essen, Germany, 45147 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Forsyth Medical Center Winston-Salem, United States, 27103 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsklinikum Münster Münster, Germany, 48149 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations North County Neurology Associates Oceanside, United States, 92056-4405 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of California-San Diego Medical Center San Diego, United States, 92103-8765 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum der Johann Wolfgang Goethe Universität Frankfurt, Germany, 60596 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kliniken und Polikliniken der Albert-Ludwigs-Universität Freiburg, Germany, 79106 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Westpfalz-Klinikum GmbH Kaiserslautern, Germany, 67655 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations The Queen's Medical Center Honolulu, United States, 96813-2413 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations MetroHealth Medical Center Cleveland, United States, 44109-1998 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of North Carolina Chapel Hill, United States, 27599-7065 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Crozer-Chester Medical Center Upland, United States, 19013-3995 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Office of Dr. Harmeet Sachdev, MD San Jose, United States, 95124 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations UCLA Emergency Medical Center Los Angeles, United States, 90024-1777 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations North Memorial Health Care Robbinsdale, United States, 55422-2900 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dekalb Medical Center Decatur, United States, 30033 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Overlake Hospital Medical Center Bellevue, United States, 98004-4687 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Foothills Medical Centre Calgary, Canada, T2N 2T9 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ottawa Hospital-General Campus Ottawa, Canada, K1H 8L6 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Queen Elizabeth II Health Sciences Centre Halifax, Canada, B3H 3A7 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Trilium Health Centre Mississauga, Canada, L5B 1B8 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Toronto Western Hospital-University Health Network Toronto, Canada, M5T 2S8 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hopital Charles LeMoyne Greenfield Park, Canada, J4V 2H1 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Royal University Hospital Saskatoon, Canada, S7N 0W8 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Center for Neurological Research Lethbridge, Canada, T1KOC9 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Penticton Regional Hospital Penticton, Canada, V2A 3G6 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations St. Boniface General Hospital Winnipeg, Canada, R2H 2A6 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations The Barzilai Medical Center Ashkelon Ashkelon, Israel, 78306 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Mercy Ruan Neurology Clinic Des Moines, United States, 50314 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Gold Coast Hospital Southport, Australia, 4215 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. Sant' Anna Como, Italy, 22100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Long Island Jewish Medical Center New Hyde Park, United States, 11040-1496 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Medizinische Einrichtungen der Universität zu Köln Köln, Germany, 50931 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Florida Neurovascular Institute Tampa, United States, 33606 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsklinikum Otto-von Guericke - Magdeburg Magdeburg, Germany, 39112 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum der Ernst-Moritz-Arndt-Universität Greifswald, Germany, 17489 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Rhön-Klinikum AG Bad Neustadt, Germany, 97616 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Vivantes Klinikum im Friedrichshain Berlin, Germany, 10249 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum der Universität Würzburg Würzburg, Germany, 97080 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Valley Hospital Ridgewood, United States, 07450 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kliniken Nord und Süd Nürnberg, Germany, 90419 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Baylor College of Medicine Houston, United States, 77030 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Johns Hopkins University School of Medicine Baltimore, United States, 21224 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum Aschaffenburg Aschaffenburg, Germany, 63739 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Providence St.Vincent Medical Center Portland, United States, 97225 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Coastal Neurology, PA Beaufort, United States, 29902-5472 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Brain Matters, Inc. Boynton Beach, United States, 33435-6000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Neurologic Consultants, PA Ft. Lauderdale, United States, 33308 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Solaris Health System/JFK Medical Center Edison, United States, 08818-3903 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Erlanger Medical Center Chattanooga, United States, 37403-2112 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations SUNY University Hospital/Health Science Center Stony Brook, United States, 11794 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations London Health Sciences Centre London, Canada, N6A 5A5 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Office of Dr. Donald A. Cameron, MD North Vancouver, Canada, V7L 2L3 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Alberta Edmonton, Canada, T6G 2B7 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hopital de L'Enfant Jesus Quebec City, Canada, G1J 1Z4 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Vancouver Hospital/Health Science Center Vancouver, Canada, V5Z 1M9 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Victoria General Hospital - Victoria Victoria, Canada, V8Z 6R5 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Complexe Hospitalier de la Sagamie Chicoutimi, Canada, G7H 5H6 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations St. John Regional Hospital St. John, Canada, E2L 4L2 | Contact Us: E-mail: [email protected] Phone: Not Available |
For details, please refer to trial results
Additional Information
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