Repinotan in Patients With Acute Ischemic Stroke

June 9, 2009 updated by: Bayer

A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetic / Pharmacodynamic Effects of a Targeted Exposure of Intravenous Repinotan in Patients With Acute Ischemic Stroke

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

782

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Gosford, New South Wales, Australia, 2250
      • New Lambton Heights, New South Wales, Australia, 2305
    • Queensland
      • Southport, Queensland, Australia, 4215
    • Tasmania
      • Hobart, Tasmania, Australia, 7000
    • Victoria
      • Melbourne, Victoria, Australia, 3052
      • Melbourne, Victoria, Australia, 3084
      • Melbourne, Victoria, Australia, 3181
      • Melbourne, Victoria, Australia, 3011
  • Austria
      • Wien, Austria, 1021
    • Niederösterreich
      • Klosterneuburg, Niederösterreich, Austria, 3400
    • Oberösterreich
      • Linz, Oberösterreich, Austria, 4020
  • Belgium
      • Bornem, Belgium, 2880
      • Bruxelles - Brussel, Belgium, 1200
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
      • Edmonton, Alberta, Canada, T6G 2B7
      • Lethbridge, Alberta, Canada, T1KOC9
    • British Columbia
      • North Vancouver, British Columbia, Canada, V7L 2L3
      • Penticton, British Columbia, Canada, V2A 3G6
      • Vancouver, British Columbia, Canada, V5Z 1M9
      • Victoria, British Columbia, Canada, V8Z 6R5
    • Manitoba
      • Winnipeg, Manitoba, Canada, R2H 2A6
    • New Brunswick
      • St. John, New Brunswick, Canada, E2L 4L2
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 3A7
    • Ontario
      • London, Ontario, Canada, N6A 5A5
      • Mississauga, Ontario, Canada, L5B 1B8
      • Ottawa, Ontario, Canada, K1H 8L6
      • Toronto, Ontario, Canada, M5T 2S8
    • Quebec
      • Chicoutimi, Quebec, Canada, G7H 5H6
      • Greenfield Park, Quebec, Canada, J4V 2H1
      • Quebec City, Quebec, Canada, G1J 1Z4
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 0W8
  • Finland
      • Helsinki, Finland, 00290
      • Kuopio, Finland, 70120
      • Lahti, Finland, 15850
      • Mikkeli, Finland, FIN-50100
  • France
      • Bordeaux, France, 33000
      • Nice, France, 06200
  • Germany
      • Berlin, Germany, 10117
      • Berlin, Germany, 10249
    • Baden-Württemberg
      • Freiburg, Baden-Württemberg, Germany, 79106
      • Heidelberg, Baden-Württemberg, Germany, 69120
      • Tübingen, Baden-Württemberg, Germany, 72076
    • Bayern
      • Aschaffenburg, Bayern, Germany, 63739
      • Bad Neustadt, Bayern, Germany, 97616
      • Erlangen, Bayern, Germany, 91054
      • München, Bayern, Germany, 81377
      • München, Bayern, Germany, 81545
      • Nürnberg, Bayern, Germany, 90419
      • Regensburg, Bayern, Germany, 93053
      • Würzburg, Bayern, Germany, 97080
    • Hessen
      • Frankfurt, Hessen, Germany, 60596
    • Mecklenburg-Vorpommern
      • Greifswald, Mecklenburg-Vorpommern, Germany, 17489
    • Nordrhein-Westfalen
      • Essen, Nordrhein-Westfalen, Germany, 45147
      • Köln, Nordrhein-Westfalen, Germany, 50931
      • Minden, Nordrhein-Westfalen, Germany, 32427
      • Münster, Nordrhein-Westfalen, Germany, 48149
    • Rheinland-Pfalz
      • Kaiserslautern, Rheinland-Pfalz, Germany, 67655
    • Sachsen
      • Leipzig, Sachsen, Germany, 04103
    • Sachsen-Anhalt
      • Magdeburg, Sachsen-Anhalt, Germany, 39112
  • Hungary
      • Miskolc, Hungary, 3526
  • Israel
      • Ashkelon, Israel, 78306
      • Haifa, Israel, 31048
      • Haifa, Israel, 31096
      • Holon, Israel, 58100
      • Nahariya, Israel, 22100
      • Tel Aviv, Israel, 64239
      • Tel Hashomer, Israel, 52621
    • Isarel
      • Petach Tikva, Isarel, Israel, 49372
  • Italy
      • Como, Italy, 22100
      • L'Aquila, Italy, 67100
      • Milano, Italy, 20153
      • Pavia, Italy, 27100
      • Perugia, Italy, 06126
      • Reggio Emilia, Italy, 42100
      • Roma, Italy, 00155
      • Verona, Italy, 37126
      • Vibo Valentia, Italy, 89900
      • Vicenza, Italy, 36100
  • Netherlands
      • Groningen, Netherlands, 9713 GZ
      • Nijmegen, Netherlands, 6525 GA
  • Spain
      • Barcelona, Spain, 08003
      • Barcelona, Spain, 08035
      • Madrid, Spain, 28046
      • Valencia, Spain, 46010
      • Zaragoza, Spain, 50009
    • A Coruña
      • Santiago de Compostela, A Coruña, Spain, 15706
  • Sweden
      • Stockholm, Sweden, 171 76
      • Umeå, Sweden, 901 85
  • United Kingdom
    • Leicestershire
      • Leicester, Leicestershire, United Kingdom, LE1 5WW
    • Strathclyde
      • Glasgow, Strathclyde, United Kingdom, G51 4TG
    • Tayside
      • Dundee, Tayside, United Kingdom, DD2 1UB
  • United States
    • California
      • Los Angeles, California, United States, 90024-1777
      • Oceanside, California, United States, 92056-4405
      • San Diego, California, United States, 92103-8765
      • San Jose, California, United States, 95124
    • Florida
      • Boynton Beach, Florida, United States, 33435-6000
      • Ft. Lauderdale, Florida, United States, 33308
      • Ocala, Florida, United States, 34471
      • Tampa, Florida, United States, 33606
    • Georgia
      • Decatur, Georgia, United States, 30033
    • Hawaii
      • Honolulu, Hawaii, United States, 96813-2413
    • Iowa
      • Des Moines, Iowa, United States, 50314
    • Maryland
      • Baltimore, Maryland, United States, 21224
    • Minnesota
      • Robbinsdale, Minnesota, United States, 55422-2900
    • Montana
      • Great Falls, Montana, United States, 59405
    • New Jersey
      • Edison, New Jersey, United States, 08818-3903
      • Ridgewood, New Jersey, United States, 07450
    • New York
      • New Hyde Park, New York, United States, 11040-1496
      • Stony Brook, New York, United States, 11794
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-7065
      • Winston-Salem, North Carolina, United States, 27103
    • Ohio
      • Cleveland, Ohio, United States, 44109-1998
    • Oregon
      • Portland, Oregon, United States, 97225
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
      • Upland, Pennsylvania, United States, 19013-3995
    • South Carolina
      • Beaufort, South Carolina, United States, 29902-5472
    • Tennessee
      • Chattanooga, Tennessee, United States, 37403-2112
    • Texas
      • Houston, Texas, United States, 77030
    • Washington
      • Bellevue, Washington, United States, 98004-4687

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Arm 2
Drug: Placebo
All patients receive 1.25 mg of placebo
Active Comparator: Arm 1
Drug: Repinotan HCl (BAYX3702)
All patients receive 1.25 mg of repinotan

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2000

Study Completion (Actual)

September 1, 2004

Study Registration Dates

First Submitted

September 6, 2002

First Submitted That Met QC Criteria

September 6, 2002

First Posted (Estimate)

September 9, 2002

Study Record Updates

Last Update Posted (Estimate)

June 12, 2009

Last Update Submitted That Met QC Criteria

June 9, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 100282

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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