Repinotan in Patients With Acute Ischemic Stroke

NCT00044915 | Completed Phase 2

• 1 other identifier: 100282
• Study Type: interventional
• Target: 782
• Locations: 14 countries
• Sites: 116

Brief Summary

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.

Conditions

Stroke; Acute Ischemic Stroke

Keywords

Acute Ischemic Stroke Without Hemorrhage

Study Arms (2)

Arm 1

ACTIVE COMPARATOR

Drug: Repinotan HCl (BAYX3702)

Arm 2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Repinotan HCl (BAYX3702) DRUG

All patients receive 1.25 mg of repinotan

Arm 1

Placebo DRUG

All patients receive 1.25 mg of placebo

Arm 2

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bayer: lead

Study Sites (119)

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Los Angeles, California, 90024-1777, United States

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Oceanside, California, 92056-4405, United States

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San Diego, California, 92103-8765, United States

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San Jose, California, 95124, United States

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Boynton Beach, Florida, 33435-6000, United States

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Fort Lauderdale, Florida, 33308, United States

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Ocala, Florida, 34471, United States

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Tampa, Florida, 33606, United States

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Decatur, Georgia, 30033, United States

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Honolulu, Hawaii, 96813-2413, United States

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Des Moines, Iowa, 50314, United States

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Baltimore, Maryland, 21224, United States

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Robbinsdale, Minnesota, 55422-2900, United States

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Great Falls, Montana, 59405, United States

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Edison, New Jersey, 08818-3903, United States

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Ridgewood, New Jersey, 07450, United States

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New Hyde Park, New York, 11040-1496, United States

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Stony Brook, New York, 11794, United States

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Chapel Hill, North Carolina, 27599-7065, United States

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Winston-Salem, North Carolina, 27103, United States

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Cleveland, Ohio, 44109-1998, United States

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Portland, Oregon, 97225, United States

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Philadelphia, Pennsylvania, 19107, United States

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Upland, Pennsylvania, 19013-3995, United States

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Beaufort, South Carolina, 29902-5472, United States

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Chattanooga, Tennessee, 37403-2112, United States

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Houston, Texas, 77030, United States

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Bellevue, Washington, 98004-4687, United States

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Gosford, New South Wales, 2250, Australia

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New Lambton Heights, New South Wales, 2305, Australia

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Southport, Queensland, 4215, Australia

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Hobart, Tasmania, 7000, Australia

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Melbourne, Victoria, 3011, Australia

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Melbourne, Victoria, 3052, Australia

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Melbourne, Victoria, 3084, Australia

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Melbourne, Victoria, 3181, Australia

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Klosterneuburg, Lower Austria, 3400, Austria

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Linz, Upper Austria, 4020, Austria

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Vienna, Vienna, 1021, Austria

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Bornem, 2880, Belgium

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Bruxelles - Brussel, 1200, Belgium

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Calgary, Alberta, T2N 2T9, Canada

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Edmonton, Alberta, T6G 2B7, Canada

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Lethbridge, Alberta, T1KOC9, Canada

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North Vancouver, British Columbia, V7L 2L3, Canada

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Penticton, British Columbia, V2A 3G6, Canada

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Vancouver, British Columbia, V5Z 1M9, Canada

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Victoria, British Columbia, V8Z 6R5, Canada

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Winnipeg, Manitoba, R2H 2A6, Canada

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Saint John, New Brunswick, E2L 4L2, Canada

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Halifax, Nova Scotia, B3H 3A7, Canada

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London, Ontario, N6A 5A5, Canada

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Mississauga, Ontario, L5B 1B8, Canada

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Ottawa, Ontario, K1H 8L6, Canada

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Toronto, Ontario, M5T 2S8, Canada

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Chicoutimi, Quebec, G7H 5H6, Canada

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Greenfield Park, Quebec, J4V 2H1, Canada

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Québec, Quebec, G1J 1Z4, Canada

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Saskatoon, Saskatchewan, S7N 0W8, Canada

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Helsinki, 00290, Finland

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Kuopio, 70120, Finland

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Lahti, 15850, Finland

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Mikkeli, FIN-50100, Finland

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Bordeaux, 33000, France

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Nice, 06200, France

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Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

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Heidelberg, Baden-Wurttemberg, 69120, Germany

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Tübingen, Baden-Wurttemberg, 72076, Germany

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Aschaffenburg, Bavaria, 63739, Germany

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Bad Neustadt an der Saale, Bavaria, 97616, Germany

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Erlangen, Bavaria, 91054, Germany

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München, Bavaria, 81377, Germany

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München, Bavaria, 81545, Germany

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Nuremberg, Bavaria, 90419, Germany

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Regensburg, Bavaria, 93053, Germany

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Würzburg, Bavaria, 97080, Germany

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Frankfurt am Main, Hesse, 60596, Germany

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Greifswald, Mecklenburg-Vorpommern, 17489, Germany

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Cologne, North Rhine-Westphalia, 50931, Germany

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Essen, North Rhine-Westphalia, 45147, Germany

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Minden, North Rhine-Westphalia, 32427, Germany

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Münster, North Rhine-Westphalia, 48149, Germany

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Kaiserslautern, Rhineland-Palatinate, 67655, Germany

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Leipzig, Saxony, 04103, Germany

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Magdeburg, Saxony-Anhalt, 39112, Germany

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Berlin, State of Berlin, 10117, Germany

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Berlin, State of Berlin, 10249, Germany

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Miskolc, 3526, Hungary

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Petah Tikva, Isarel, 49372, Israel

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Ashkelon, 78306, Israel

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Haifa, 31048, Israel

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Haifa, 31096, Israel

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Holon, 58100, Israel

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Nahariya, 22100, Israel

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Tel Aviv, 64239, Israel

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Tel Litwinsky, 52621, Israel

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Como, 22100, Italy

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L’Aquila, 67100, Italy

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Milan, 20153, Italy

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Pavia, 27100, Italy

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Perugia, 06126, Italy

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Reggio Emilia, 42100, Italy

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Roma, 00155, Italy

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Verona, 37126, Italy

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Vibo Valentia, 89900, Italy

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Vicenza, 36100, Italy

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Groningen, 9713 GZ, Netherlands

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Nijmegen, 6525 GA, Netherlands

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Santiago de Compostela, A Coruña, 15706, Spain

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Barcelona, Barcelona, 08003, Spain

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Barcelona, Barcelona, 08035, Spain

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Madrid, Madrid, 28046, Spain

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Valencia, Valencia, 46010, Spain

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Zaragoza, Zaragoza, 50009, Spain

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Stockholm, 171 76, Sweden

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Umeå, 901 85, Sweden

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Leicester, Leicestershire, LE1 5WW, United Kingdom

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Glasgow, Strathclyde, G51 4TG, United Kingdom

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Dundee, Tayside, DD2 1UB, United Kingdom

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MeSH Terms

Conditions

Stroke; Ischemic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 6, 2002
• First Posted: September 9, 2002
• Study Start: December 1, 2000
• Study Completion: September 1, 2004
• Last Updated: June 12, 2009

Record last verified: 2009-06

Locations

AU (8); BE (2); FI (4); ES (6); US (28); GB (3); HU (1); CA (18); FR (2); IL (8); NL (2); DE (22); IT (10); SE (2)