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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COMPLETED
PHASE2
782 participants
INTERVENTIONAL
2000-12-31
2004-09-30
Brief Summary
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Study to Gather Information About Proper Dosing and Safety of the Oral FXIa Inhibitor BAY 2433334 in Patients Following a Recent Non Cardioembolic Ischemic Stroke Which Occurs When a Blood Clot Has Formed Somewhere in the Human Body (But Not in the Heart) Travelled to the Brain.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Arm 1
Repinotan HCl (BAYX3702)
All patients receive 1.25 mg of repinotan
Arm 2
Placebo
All patients receive 1.25 mg of placebo
Interventions
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Repinotan HCl (BAYX3702)
All patients receive 1.25 mg of repinotan
Placebo
All patients receive 1.25 mg of placebo
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Bayer HealthCare AG
Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Los Angeles, California, United States
Oceanside, California, United States
San Diego, California, United States
San Jose, California, United States
Boynton Beach, Florida, United States
Fort Lauderdale, Florida, United States
Ocala, Florida, United States
Tampa, Florida, United States
Decatur, Georgia, United States
Honolulu, Hawaii, United States
Des Moines, Iowa, United States
Baltimore, Maryland, United States
Robbinsdale, Minnesota, United States
Great Falls, Montana, United States
Edison, New Jersey, United States
Ridgewood, New Jersey, United States
New Hyde Park, New York, United States
Stony Brook, New York, United States
Chapel Hill, North Carolina, United States
Winston-Salem, North Carolina, United States
Cleveland, Ohio, United States
Portland, Oregon, United States
Philadelphia, Pennsylvania, United States
Upland, Pennsylvania, United States
Beaufort, South Carolina, United States
Chattanooga, Tennessee, United States
Houston, Texas, United States
Bellevue, Washington, United States
Gosford, New South Wales, Australia
New Lambton Heights, New South Wales, Australia
Southport, Queensland, Australia
Hobart, Tasmania, Australia
Melbourne, Victoria, Australia
Melbourne, Victoria, Australia
Melbourne, Victoria, Australia
Melbourne, Victoria, Australia
Klosterneuburg, Lower Austria, Austria
Linz, Upper Austria, Austria
Vienna, Vienna, Austria
Bornem, , Belgium
Bruxelles - Brussel, , Belgium
Calgary, Alberta, Canada
Edmonton, Alberta, Canada
Lethbridge, Alberta, Canada
North Vancouver, British Columbia, Canada
Penticton, British Columbia, Canada
Vancouver, British Columbia, Canada
Victoria, British Columbia, Canada
Winnipeg, Manitoba, Canada
Saint John, New Brunswick, Canada
Halifax, Nova Scotia, Canada
London, Ontario, Canada
Mississauga, Ontario, Canada
Ottawa, Ontario, Canada
Toronto, Ontario, Canada
Chicoutimi, Quebec, Canada
Greenfield Park, Quebec, Canada
Québec, Quebec, Canada
Saskatoon, Saskatchewan, Canada
Helsinki, , Finland
Kuopio, , Finland
Lahti, , Finland
Mikkeli, , Finland
Bordeaux, , France
Nice, , France
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Heidelberg, Baden-Wurttemberg, Germany
Tübingen, Baden-Wurttemberg, Germany
Aschaffenburg, Bavaria, Germany
Bad Neustadt an der Saale, Bavaria, Germany
Erlangen, Bavaria, Germany
München, Bavaria, Germany
München, Bavaria, Germany
Nuremberg, Bavaria, Germany
Regensburg, Bavaria, Germany
Würzburg, Bavaria, Germany
Frankfurt am Main, Hesse, Germany
Greifswald, Mecklenburg-Vorpommern, Germany
Cologne, North Rhine-Westphalia, Germany
Essen, North Rhine-Westphalia, Germany
Minden, North Rhine-Westphalia, Germany
Münster, North Rhine-Westphalia, Germany
Kaiserslautern, Rhineland-Palatinate, Germany
Leipzig, Saxony, Germany
Magdeburg, Saxony-Anhalt, Germany
Berlin, State of Berlin, Germany
Berlin, State of Berlin, Germany
Miskolc, , Hungary
Petah Tikva, Isarel, Israel
Ashkelon, , Israel
Haifa, , Israel
Haifa, , Israel
Holon, , Israel
Nahariya, , Israel
Tel Aviv, , Israel
Tel Litwinsky, , Israel
Como, , Italy
L’Aquila, , Italy
Milan, , Italy
Pavia, , Italy
Perugia, , Italy
Reggio Emilia, , Italy
Roma, , Italy
Verona, , Italy
Vibo Valentia, , Italy
Vicenza, , Italy
Groningen, , Netherlands
Nijmegen, , Netherlands
Santiago de Compostela, A Coruña, Spain
Barcelona, Barcelona, Spain
Barcelona, Barcelona, Spain
Madrid, Madrid, Spain
Valencia, Valencia, Spain
Zaragoza, Zaragoza, Spain
Stockholm, , Sweden
Umeå, , Sweden
Leicester, Leicestershire, United Kingdom
Glasgow, Strathclyde, United Kingdom
Dundee, Tayside, United Kingdom
Countries
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Other Identifiers
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100282
Identifier Type: -
Identifier Source: org_study_id
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