Trial Condition(s):

Stroke, Acute Ischemic Stroke

Repinotan in Patients with Acute Ischemic Stroke

Bayer Identifier:

100282

ClinicalTrials.gov Identifier:

NCT00044915

EudraCT Number:

Not Available

Study Completed

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
782
Trial Dates
black-arrow
Phase
2
Could I receive a placebo?
Yes
Products
Repinotan (BAYX3702)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Royal Melbourne Hospital

Melbourne, Australia, 3052

Status
Completed
 
Locations

Hôpital Pellegrin Tripode - Bordeaux

BORDEAUX, France, 33000

Status
Completed
 
Locations

Ninewells Hospital

Dundee, United Kingdom, DD2 1UB

Status
Completed
 
Locations

Chaim Sheba Medical Center

Tel Hashomer, Israel, 52621

Status
Completed
 
Locations

Universitair Medisch Centrum Groningen

GRONINGEN, Netherlands, 9713 GZ

Status
Completed
 
Locations

Gosford Hospital

Gosford, Australia, 2250

Status
Completed
 
Locations

Sint-Jozefkliniek

BORNEM, Belgium, 2880

Status
Completed
 
Locations

Klinikum Minden

Minden, Germany, 32427

Status
Completed
 
Locations

Hospital del Mar

Barcelona, Spain, 08003

Status
Completed
 
Locations

Mikkelin keskussairaala

Mikkeli, Finland, FIN-50100

Status
Completed
 
Locations

Southern General Hospital

Glasgow, United Kingdom, G51 4TG

Status
Completed
 
Locations

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel, 64239

Status
Completed
 
Locations

A.O.U. Policlinico Umberto I

Roma, Italy, 00155

Status
Completed
 
Locations

Donauklinikum- Standort Gugging

Klosterneuburg, Austria, 3400

Status
Completed
 
Locations

Hospital Clínico Universitario de Santiago de Compostela

Santiago de Compostela, Spain, 15706

Status
Completed
 
Locations

Borsod County Hospital

Miskolc, Hungary, 3526

Status
Completed
 
Locations

Universitätsklinikum Charite zu Berlin

Berlin, Germany, 10117

Status
Completed
 
Locations

HUS, Meilahden sairaala

Helsinki, Finland, 00290

Status
Completed
 
Locations

IRCCS Ist Neurologico Mondino

Pavia, Italy, 27100

Status
Completed
 
Locations

Karolinska University Hospital

Stockholm, Sweden, 171 76

Status
Completed
 
Locations

Landes-Nervenklinik Wagner-Jauregg Linz

Linz, Austria, 4020

Status
Completed
 
Locations

Austin Repatriation Medical Centre, Austin Campus

Melbourne, Australia, 3084

Status
Completed
 
Locations

Universität Leipzig

Leipzig, Germany, 04103

Status
Completed
 
Locations

Päijät-Hämeen keskussairaala

Lahti, Finland, 15850

Status
Completed
 
Locations

Hôpital Pasteur - Nice

NICE, France, 06200

Status
Completed
 
Locations

Western Galille Hospital Nahariya

Nahariya, Israel, 22100

Status
Completed
 
Locations

Krankenhaus der Barmherzigen Brüder

Wien, Austria, 1021

Status
Completed
 
Locations

Ciutat Sanitària i Universitaria de la Vall d'Hebrón

Barcelona, Spain, 08035

Status
Completed
 
Locations

John Hunter Hospital

New Lambton Heights, Australia, 2305

Status
Completed
 
Locations

Klinikum Großhadern der Ludwig-Maximilians-Universität

München, Germany, 81377

Status
Completed
 
Locations

Universitair Medisch Centrum St. Radboud

NIJMEGEN, Netherlands, 6525 GA

Status
Completed
 
Locations

AULSS 06 Vicenza - Veneto

Vicenza, Italy, 36100

Status
Completed
 
Locations

Norrlands Universitetssjukhus

Umeå, Sweden, 901 85

Status
Completed
 
Locations

CU Saint-Luc/UZ St-Luc

BRUXELLES - BRUSSEL, Belgium, 1200

Status
Completed
 
Locations

Kuopion yliopistollinen sairaala

Kuopio, Finland, 70120

Status
Completed
 
Locations

Leicester Royal Infirmary

Leicester, United Kingdom, LE1 5WW

Status
Completed
 
Locations

Edith Wolfson Medical Center

Holon, Israel, 58100

Status
Completed
 
Locations

Ospedale Borgo Trento

Verona, Italy, 37126

Status
Completed
 
Locations

Bnai Zion Medical Center

Haifa, Israel, 31048

Status
Completed
 
Locations

A.O. di Reggio Emilia

Reggio Emilia, Italy, 42100

Status
Completed
 
Locations

Ocala Neurodiagnostic Center

Ocala, United States, 34471

Status
Completed
 
Locations

Klinikum der Eberhard-Karls-Universität Tübingen

Tübingen, Germany, 72076

Status
Completed
 
Locations

Royal Hobart Hospital

Hobart, Australia, 7000

Status
Completed
 
Locations

Rambam Medical Center

Haifa, Israel, 31096

Status
Completed
 
Locations

Policlinico Monteluce

Perugia, Italy, 06126

Status
Completed
 
Locations

Western Medical Centre

Melbourne, Australia, 3011

Status
Completed
 
Locations

Klinikum der Universität Regensburg

Regensburg, Germany, 93053

Status
Completed
 
Locations

The Alfred Hospital

Melbourne, Australia, 3181

Status
Completed
 
Locations

Städ. Krankenhaus München-Harlaching

München, Germany, 81545

Status
Completed
 
Locations

Hospital Clínico Universitario Lozano Blesa

Zaragoza, Spain, 50009

Status
Completed
 
Locations

Rabin Medical Center, Campus Golda

Petach Tikva, Israel, 49372

Status
Completed
 
Locations

A.O. Osp San Carlo Borromeo

Milano, Italy, 20153

Status
Completed
 
Locations

Office of Dr. Rodney D. Bell, MD

Philadelphia, United States, 19107

Status
Completed
 
Locations

AUSL 4 L'Aquila - Abruzzo

L'Aquila, Italy, 67100

Status
Completed
 
Locations

Universitätsklinikum Heidelberg

Heidelberg, Germany, 69120

Status
Completed
 
Locations

Hospital Clínico Universitario de Valencia

Valencia, Spain, 46010

Status
Completed
 
Locations

Friedrich-Alexander-Universität Erlangen-Nürnberg

Erlangen, Germany, 91054

Status
Completed
 
Locations

Hospital Universitario "La Paz"

Madrid, Spain, 28046

Status
Completed
 
Locations

ASL 8 Vibo Valentia - Calabria

Vibo Valentia, Italy, 89900

Status
Completed
 
Locations

Advanced Neurology Specialists

Great Falls, United States, 59405

Status
Completed
 
Locations

Medizinische Einrichtungen der Universität Essen

Essen, Germany, 45147

Status
Completed
 
Locations

Forsyth Medical Center

Winston-Salem, United States, 27103

Status
Completed
 
Locations

Universitätsklinikum Münster

Münster, Germany, 48149

Status
Completed
 
Locations

North County Neurology Associates

Oceanside, United States, 92056-4405

Status
Completed
 
Locations

University of California-San Diego Medical Center

San Diego, United States, 92103-8765

Status
Completed
 
Locations

Klinikum der Johann Wolfgang Goethe Universität

Frankfurt, Germany, 60596

Status
Completed
 
Locations

Kliniken und Polikliniken der Albert-Ludwigs-Universität

Freiburg, Germany, 79106

Status
Completed
 
Locations

Westpfalz-Klinikum GmbH

Kaiserslautern, Germany, 67655

Status
Completed
 
Locations

The Queen's Medical Center

Honolulu, United States, 96813-2413

Status
Completed
 
Locations

MetroHealth Medical Center

Cleveland, United States, 44109-1998

Status
Completed
 
Locations

University of North Carolina

Chapel Hill, United States, 27599-7065

Status
Completed
 
Locations

Crozer-Chester Medical Center

Upland, United States, 19013-3995

Status
Completed
 
Locations

Office of Dr. Harmeet Sachdev, MD

San Jose, United States, 95124

Status
Completed
 
Locations

UCLA Emergency Medical Center

Los Angeles, United States, 90024-1777

Status
Completed
 
Locations

North Memorial Health Care

Robbinsdale, United States, 55422-2900

Status
Completed
 
Locations

Dekalb Medical Center

Decatur, United States, 30033

Status
Completed
 
Locations

Overlake Hospital Medical Center

Bellevue, United States, 98004-4687

Status
Completed
 
Locations

Foothills Medical Centre

Calgary, Canada, T2N 2T9

Status
Completed
 
Locations

Ottawa Hospital-General Campus

Ottawa, Canada, K1H 8L6

Status
Completed
 
Locations

Queen Elizabeth II Health Sciences Centre

Halifax, Canada, B3H 3A7

Status
Completed
 
Locations

Trilium Health Centre

Mississauga, Canada, L5B 1B8

Status
Completed
 
Locations

Toronto Western Hospital-University Health Network

Toronto, Canada, M5T 2S8

Status
Completed
 
Locations

Hopital Charles LeMoyne

Greenfield Park, Canada, J4V 2H1

Status
Completed
 
Locations

Royal University Hospital

Saskatoon, Canada, S7N 0W8

Status
Completed
 
Locations

Center for Neurological Research

Lethbridge, Canada, T1KOC9

Status
Completed
 
Locations

Penticton Regional Hospital

Penticton, Canada, V2A 3G6

Status
Completed
 
Locations

St. Boniface General Hospital

Winnipeg, Canada, R2H 2A6

Status
Completed
 
Locations

The Barzilai Medical Center Ashkelon

Ashkelon, Israel, 78306

Status
Completed
 
Locations

Mercy Ruan Neurology Clinic

Des Moines, United States, 50314

Status
Completed
 
Locations

Gold Coast Hospital

Southport, Australia, 4215

Status
Completed
 
Locations

A.O. Sant' Anna

Como, Italy, 22100

Status
Completed
 
Locations

Long Island Jewish Medical Center

New Hyde Park, United States, 11040-1496

Status
Completed
 
Locations

Medizinische Einrichtungen der Universität zu Köln

Köln, Germany, 50931

Status
Completed
 
Locations

Florida Neurovascular Institute

Tampa, United States, 33606

Status
Completed
 
Locations

Universitätsklinikum Otto-von Guericke - Magdeburg

Magdeburg, Germany, 39112

Status
Completed
 
Locations

Klinikum der Ernst-Moritz-Arndt-Universität

Greifswald, Germany, 17489

Status
Completed
 
Locations

Rhön-Klinikum AG

Bad Neustadt, Germany, 97616

Status
Completed
 
Locations

Vivantes Klinikum im Friedrichshain

Berlin, Germany, 10249

Status
Completed
 
Locations

Klinikum der Universität Würzburg

Würzburg, Germany, 97080

Status
Completed
 
Locations

Valley Hospital

Ridgewood, United States, 07450

Status
Completed
 
Locations

Kliniken Nord und Süd

Nürnberg, Germany, 90419

Status
Completed
 
Locations

Baylor College of Medicine

Houston, United States, 77030

Status
Completed
 
Locations

Johns Hopkins University School of Medicine

Baltimore, United States, 21224

Status
Completed
 
Locations

Klinikum Aschaffenburg

Aschaffenburg, Germany, 63739

Status
Completed
 
Locations

Providence St.Vincent Medical Center

Portland, United States, 97225

Status
Completed
 
Locations

Coastal Neurology, PA

Beaufort, United States, 29902-5472

Status
Completed
 
Locations

Brain Matters, Inc.

Boynton Beach, United States, 33435-6000

Status
Completed
 
Locations

Neurologic Consultants, PA

Ft. Lauderdale, United States, 33308

Status
Completed
 
Locations

Solaris Health System/JFK Medical Center

Edison, United States, 08818-3903

Status
Completed
 
Locations

Erlanger Medical Center

Chattanooga, United States, 37403-2112

Status
Completed
 
Locations

SUNY University Hospital/Health Science Center

Stony Brook, United States, 11794

Status
Completed
 
Locations

London Health Sciences Centre

London, Canada, N6A 5A5

Status
Completed
 
Locations

Office of Dr. Donald A. Cameron, MD

North Vancouver, Canada, V7L 2L3

Status
Completed
 
Locations

University of Alberta

Edmonton, Canada, T6G 2B7

Status
Completed
 
Locations

Hopital de L'Enfant Jesus

Quebec City, Canada, G1J 1Z4

Status
Completed
 
Locations

Vancouver Hospital/Health Science Center

Vancouver, Canada, V5Z 1M9

Status
Completed
 
Locations

Victoria General Hospital - Victoria

Victoria, Canada, V8Z 6R5

Status
Completed
 
Locations

Complexe Hospitalier de la Sagamie

Chicoutimi, Canada, G7H 5H6

Status
Completed
 
Locations

St. John Regional Hospital

St. John, Canada, E2L 4L2

Status
Completed
 

For details, please refer to trial results

Additional Information