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Repinotan in Patients With Acute Ischemic Stroke

Sponsor
Bayer (Industry)
Overall Status
Completed
CT.gov ID
NCT00044915
Collaborator
(none)
782
Enrollment
119
Locations
2
Arms
45
Duration (Months)
6.6
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Repinotan HCl (BAYX3702)
  • Drug: Placebo
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
782 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
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
Study Start Date :
Dec 1, 2000
Actual Study Completion Date :
Sep 1, 2004

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Arm 1

Drug: Repinotan HCl (BAYX3702)
All patients receive 1.25 mg of repinotan
Placebo Comparator: Arm 2

Drug: Placebo
All patients receive 1.25 mg of placebo

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Los Angeles California United States 90024-1777
    2 Oceanside California United States 92056-4405
    3 San Diego California United States 92103-8765
    4 San Jose California United States 95124
    5 Boynton Beach Florida United States 33435-6000
    6 Ft. Lauderdale Florida United States 33308
    7 Ocala Florida United States 34471
    8 Tampa Florida United States 33606
    9 Decatur Georgia United States 30033
    10 Honolulu Hawaii United States 96813-2413
    11 Des Moines Iowa United States 50314
    12 Baltimore Maryland United States 21224
    13 Robbinsdale Minnesota United States 55422-2900
    14 Great Falls Montana United States 59405
    15 Edison New Jersey United States 08818-3903
    16 Ridgewood New Jersey United States 07450
    17 New Hyde Park New York United States 11040-1496
    18 Stony Brook New York United States 11794
    19 Chapel Hill North Carolina United States 27599-7065
    20 Winston-Salem North Carolina United States 27103
    21 Cleveland Ohio United States 44109-1998
    22 Portland Oregon United States 97225
    23 Philadelphia Pennsylvania United States 19107
    24 Upland Pennsylvania United States 19013-3995
    25 Beaufort South Carolina United States 29902-5472
    26 Chattanooga Tennessee United States 37403-2112
    27 Houston Texas United States 77030
    28 Bellevue Washington United States 98004-4687
    29 Gosford New South Wales Australia 2250
    30 New Lambton Heights New South Wales Australia 2305
    31 Southport Queensland Australia 4215
    32 Hobart Tasmania Australia 7000
    33 Melbourne Victoria Australia 3011
    34 Melbourne Victoria Australia 3052
    35 Melbourne Victoria Australia 3084
    36 Melbourne Victoria Australia 3181
    37 Klosterneuburg Niederösterreich Austria 3400
    38 Linz Oberösterreich Austria 4020
    39 Wien Austria 1021
    40 Bornem Belgium 2880
    41 Bruxelles - Brussel Belgium 1200
    42 Calgary Alberta Canada T2N 2T9
    43 Edmonton Alberta Canada T6G 2B7
    44 Lethbridge Alberta Canada T1KOC9
    45 North Vancouver British Columbia Canada V7L 2L3
    46 Penticton British Columbia Canada V2A 3G6
    47 Vancouver British Columbia Canada V5Z 1M9
    48 Victoria British Columbia Canada V8Z 6R5
    49 Winnipeg Manitoba Canada R2H 2A6
    50 St. John New Brunswick Canada E2L 4L2
    51 Halifax Nova Scotia Canada B3H 3A7
    52 London Ontario Canada N6A 5A5
    53 Mississauga Ontario Canada L5B 1B8
    54 Ottawa Ontario Canada K1H 8L6
    55 Toronto Ontario Canada M5T 2S8
    56 Chicoutimi Quebec Canada G7H 5H6
    57 Greenfield Park Quebec Canada J4V 2H1
    58 Quebec City Quebec Canada G1J 1Z4
    59 Saskatoon Saskatchewan Canada S7N 0W8
    60 Helsinki Finland 00290
    61 Kuopio Finland 70120
    62 Lahti Finland 15850
    63 Mikkeli Finland FIN-50100
    64 Bordeaux France 33000
    65 Nice France 06200
    66 Freiburg Baden-Württemberg Germany 79106
    67 Heidelberg Baden-Württemberg Germany 69120
    68 Tübingen Baden-Württemberg Germany 72076
    69 Aschaffenburg Bayern Germany 63739
    70 Bad Neustadt Bayern Germany 97616
    71 Erlangen Bayern Germany 91054
    72 München Bayern Germany 81377
    73 München Bayern Germany 81545
    74 Nürnberg Bayern Germany 90419
    75 Regensburg Bayern Germany 93053
    76 Würzburg Bayern Germany 97080
    77 Frankfurt Hessen Germany 60596
    78 Greifswald Mecklenburg-Vorpommern Germany 17489
    79 Essen Nordrhein-Westfalen Germany 45147
    80 Köln Nordrhein-Westfalen Germany 50931
    81 Minden Nordrhein-Westfalen Germany 32427
    82 Münster Nordrhein-Westfalen Germany 48149
    83 Kaiserslautern Rheinland-Pfalz Germany 67655
    84 Magdeburg Sachsen-Anhalt Germany 39112
    85 Leipzig Sachsen Germany 04103
    86 Berlin Germany 10117
    87 Berlin Germany 10249
    88 Miskolc Hungary 3526
    89 Petach Tikva Isarel Israel 49372
    90 Ashkelon Israel 78306
    91 Haifa Israel 31048
    92 Haifa Israel 31096
    93 Holon Israel 58100
    94 Nahariya Israel 22100
    95 Tel Aviv Israel 64239
    96 Tel Hashomer Israel 52621
    97 Como Italy 22100
    98 L'Aquila Italy 67100
    99 Milano Italy 20153
    100 Pavia Italy 27100
    101 Perugia Italy 06126
    102 Reggio Emilia Italy 42100
    103 Roma Italy 00155
    104 Verona Italy 37126
    105 Vibo Valentia Italy 89900
    106 Vicenza Italy 36100
    107 Groningen Netherlands 9713 GZ
    108 Nijmegen Netherlands 6525 GA
    109 Santiago de Compostela A Coruña Spain 15706
    110 Barcelona Spain 08003
    111 Barcelona Spain 08035
    112 Madrid Spain 28046
    113 Valencia Spain 46010
    114 Zaragoza Spain 50009
    115 Stockholm Sweden 171 76
    116 Umeå Sweden 901 85
    117 Leicester Leicestershire United Kingdom LE1 5WW
    118 Glasgow Strathclyde United Kingdom G51 4TG
    119 Dundee Tayside United Kingdom DD2 1UB

    Sponsors and Collaborators

    • Bayer

    Investigators

    • Study Director: Bayer Study Director, Bayer

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00044915
    Other Study ID Numbers:
    • 100282
    First Posted:
    Sep 9, 2002
    Last Update Posted:
    Jun 12, 2009
    Last Verified:
    Jun 1, 2009
    Keywords provided by , ,
    Acute Ischemic Stroke Without Hemorrhage
    Additional relevant MeSH terms:
    Stroke
    Ischemic Stroke
    Cerebral Infarction
    Ischemia
    Repinotan hydrochloride

    Study Results

    No Results Posted as of Jun 12, 2009