Rt-PA in the Treatment of Acute Ischemic Stroke

Phase 3

Completed

Conditions: Cerebrovascular Accident

Registration Number: NCT00153036

Lead Sponsor: Boehringer Ingelheim

Brief Summary: To collect additional confirmatory data on alteplase(rt-PA) in the European setting and to demonstrate that the treatment of patients between 3 and 4.30 hours of onset of symptoms of acute ischemic stroke with rt-PA compared to placebo-treated patients will result in an improved clinical outcome without increase of fatality rate.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 821

Inclusion Criteria

Female or male inpatients
Age: 18 - 80 years.
Clinical diagnosis of ischemic stroke causing a measurable neurological deficit defined as impairment of language, motor function, cognition and/or gaze, vision or neglect. Ischemic stroke is defined as an event characterized by the sudden onset of an acute focal neurologic deficit presumed to be due to cerebral ischemia after CT scan excludes hemorrhage.
Onset of symptoms between 3 and 4 hours prior to initiation of administration of study drug.
Stroke symptoms are to be present for at least 30 minutes and have not significantly improved before treatment. Symptoms must be distinguishable from an episode of generalized ischemia (i.e. syncope), seizure, or migraine disorder.
Patient is willing to participate voluntarily and to sign a written patient informed consent. Informed consent will be obtained from each patient or the subject's legally authorized representative or relatives, or deferred where applicable, according to the regulatory and legal requirements of the participating country.
Patients who are unable to sign but who are able to understand the meaning of participation in the study may give an oral witnessed informed consent. These patients have to make clear undoubtfully that they are willing to participate voluntarily and must be able to understand an explanation of the contents of he information sheet.
Willingness and ability to comply with the protocol.

Exclusion Criteria

Evidence of intracranial hemorrhage (ICH) on the CT-scan.
Symptoms of ischaemic attack began more than 4 hours and 30 minutes prior to infusion start or when time of symptom onset is unknown.
Minor neurological deficit or symptoms rapidly improving before start of infusion.
Severe stroke as assessed clinically (e.g. NIHSS>25) and/or by appropriate imaging techniques.
Epileptic seizure at onset of stroke
Symptoms suggestive of subarachnoid haemorrhage, even if the CT-scan is normal.
Administration of heparin within the previous 48 hours and a thromboplastin time exceeding the upper limit of normal for laboratory
History of prior stroke and concomitant diabetes. * Prior stroke within the last 3 months
Platelet below 100,000/mm3. * Systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg, or aggressive management (IV medication) necessary to reduce BP to these limits.
Blood glucose <50 or > 400 mg/dl (< 2.77 or > 22.15 mmol / l). * Known haemorraghic diathesis
Patients receiving oral anticoagulants. * Manifest or recent severe or dangerous bleeding
Known history of or suspected intracranial haemorrhage
Suspected subarachnoid haemorrhage or condition after subarachnoid haemorrhage from aneurysm
History of central nervous system damage (i.e. neoplasm, aneurysm, intracranial or spinal surgery)
Haemorrhagic retinopathy,e.g. in diabetes (vision disturbances may indicate haemorrhagic retinopathy)
Recent (less than 10 days) traumatic external heart massage, obstetrical delivery, recent puncture of a non-compressible blood-vessel (e.g. subclavian or jugular vein puncture.
bacterial endocarditis, pericarditis.* Acute pancreatitis
Documented ulcerative gastrointestinal disease during the last 3 months, oesophageal varices, arterial- aneurysm, arterial/venous malformation
Neoplasm with increased bleeding risk

Study & Design

Study Type: INTERVENTIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
modified Rankin scale (mRS) 0-1 (favourable outcome) at Day 90	at day 90

Secondary Outcome Measures

Name	Time	Method
Global outcome of four neurologic and disability scores combined	at day 90

Trial Locations

Locations (142): 135.312.43007 Boehringer Ingelheim Investigational Site
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Innsbruck, Austria
135.312.43004 Boehringer Ingelheim Investigational Site
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Graz, Austria
135.312.43006 Boehringer Ingelheim Investigational Site
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Salzburg, Austria
135.312.32006 O.L. Vrouwziekenhuis
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Aalst, Belgium
135.312.32011 Boehringer Ingelheim Investigational Site
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Kortrijk, Belgium
135.312.42004 Boehringer Ingelheim Investigational Site
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Ostrava-Vitkovice, Czech Republic
135.312.35101 Hospitais da Universidade de Coimbra
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Coimbra, Portugal
135.312.41004 Boehringer Ingelheim Investigational Site
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Lausanne, Switzerland
135.312.31001
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Amsterdam, Netherlands
135.312.32016 Boehringer Ingelheim Investigational Site
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Yvoir (Godinne), Belgium
135.312.35802 Boehringer Ingelheim Investigational Site
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Turku, Finland
135.312.33016 Boehringer Ingelheim Investigational Site
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Besançon cedex, France
135.312.35805 Boehringer Ingelheim Investigational Site
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Kuopio, Finland
135.312.33017 Boehringer Ingelheim Investigational Site
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Bourg en Bresse, France
135.312.49018 Boehringer Ingelheim Investigational Site
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Mannheim, Germany
135.312.35801 Boehringer Ingelheim Investigational Site
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Helsinki, Finland
135.312.33008 Boehringer Ingelheim Investigational Site
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Dijon cedex, France
135.312.33015 Boehringer Ingelheim Investigational Site
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Lille cedex, France
135.312.44003 Boehringer Ingelheim Investigational Site
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Glasgow, United Kingdom
135.312.44006 Boehringer Ingelheim Investigational Site
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Glasgow, United Kingdom
135.312.41003 Boehringer Ingelheim Investigational Site
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Aarau, Switzerland
135.312.44018 Boehringer Ingelheim Investigational Site
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Liverpool, United Kingdom
135.312.44026 Boehringer Ingelheim Investigational Site
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Dundee, United Kingdom
135.312.45004 Boehringer Ingelheim Investigational Site
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Glostrup, Denmark
135.312.46003 Boehringer Ingelheim Investigational Site
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Malmö, Sweden
135.312.39024 Istituto Scientifico San Raffaele
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Milano, Italy
135.312.39009 Ospedale Maggiore di BorgoTrento
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Verona, Italy
135.312.33009 Boehringer Ingelheim Investigational Site
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Auch, France
135.312.33001 Boehringer Ingelheim Investigational Site
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Lyon Cedex, France
135.312.33002 Boehringer Ingelheim Investigational Site
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Montpellier, France
135.312.33003 Boehringer Ingelheim Investigational Site
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Nice cedex 1, France
135.312.33007 Boehringer Ingelheim Investigational Site
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Paris cedex 18, France
135.312.33021 Boehringer Ingelheim Investigational Site
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Meaux, France
135.312.44024 Boehringer Ingelheim Investigational Site
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Glasgow, United Kingdom
135.312.44030 Boehringer Ingelheim Investigational Site
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London, United Kingdom
135.312.43010 Boehringer Ingelheim Investigational Site
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Klagenfurt, Austria
135.312.43012 Boehringer Ingelheim Investigational Site
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Linz, Austria
135.312.43013 Boehringer Ingelheim Investigational Site
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Linz, Austria
135.312.43008 Boehringer Ingelheim Investigational Site
🇦🇹
Ma.Gugging/Klosterneuburg, Austria
135.312.43003 Boehringer Ingelheim Investigational Site
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St. Pölten, Austria
135.312.43002 Boehringer Ingelheim Investigational Site
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Wien, Austria
135.312.32014 Boehringer Ingelheim Investigational Site
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Antwerpen, Belgium
135.312.32001 Boehringer Ingelheim Investigational Site
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Brugge, Belgium
135.312.32005 Boehringer Ingelheim Investigational Site
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Leuven, Belgium
135.312.42002 Boehringer Ingelheim Investigational Site
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Prague 5, Czech Republic
135.312.45001 Boehringer Ingelheim Investigational Site
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Copenhagen NV, Denmark
135.312.45005 Boehringer Ingelheim Investigational Site
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Aalborg, Denmark
135.312.45002 Boehringer Ingelheim Investigational Site
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Aarhus, Denmark
135.312.42001 Boehringer Ingelheim Investigational Site
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Ostrava, Czech Republic
135.312.33004 Boehringer Ingelheim Investigational Site
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Nancy, France
135.312.33020 Boehringer Ingelheim Investigational Site
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Pau cedex, France
135.312.33024 Boehringer Ingelheim Investigational Site
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Mantes la Jolie, France
135.312.33010 Boehringer Ingelheim Investigational Site
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Saint Herblain, France
135.312.33018 Boehringer Ingelheim Investigational Site
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Perpignan cedex, France
135.312.33005 Boehringer Ingelheim Investigational Site
🇫🇷
Toulouse cedex 9, France
135.312.33011 Boehringer Ingelheim Investigational Site
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Tours cedex 9, France
135.312.49031 Boehringer Ingelheim Investigational Site
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Altenburg, Germany
135.312.33022 Boehringer Ingelheim Investigational Site
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Versailles, France
135.312.49011 Boehringer Ingelheim Investigational Site
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Bamberg, Germany
135.312.49037 Boehringer Ingelheim Investigational Site
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Beeskow, Germany
135.312.49017 Boehringer Ingelheim Investigational Site
🇩🇪
Bochum, Germany
135.312.49038 Boehringer Ingelheim Investigational Site
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Frankfurt/Main, Germany
135.312.49041 Boehringer Ingelheim Investigational Site
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Hamburg, Germany
135.312.49023 Boehringer Ingelheim Investigational Site
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Hannover, Germany
135.312.49001 Boehringer Ingelheim Investigational Site
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Heidelberg, Germany
135.312.49008 Boehringer Ingelheim Investigational Site
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Köln, Germany
135.312.49014 Boehringer Ingelheim Investigational Site
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Leipzig, Germany
135.312.49004 Boehringer Ingelheim Investigational Site
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Magdeburg, Germany
135.312.49003 Boehringer Ingelheim Investigational Site
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Mainz, Germany
135.312.49002 Boehringer Ingelheim Investigational Site
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Minden, Germany
135.312.36002 University of Debrecen
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Debrecen, Hungary
135.312.49006 Boehringer Ingelheim Investigational Site
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München, Germany
135.312.30005 Boehringer Ingelheim Investigational Site
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Larissa, Greece
135.312.30004 Boehringer Ingelheim Investigational Site
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Athens, Greece
135.312.49005 Boehringer Ingelheim Investigational Site
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Siegen, Germany
135.312.36001 Aladár Petz County Hospital
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Györ, Hungary
135.312.36006 BAZ County and Teaching Hospital
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Miskolc, Hungary
135.312.30002 Boehringer Ingelheim Investigational Site
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Thessaloniki, Greece
135.312.39020 Università degli Studi
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Coppito (aq), Italy
135.312.39013 A. O. Universitaria di Careggi
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Firenze, Italy
135.312.39019 Ospedale Santa Maria Annunziata
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Firenze, Italy
135.312.39022 Ospedale di Imperia
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Imperia, Italy
135.312.39005 A. O. di Perugia - Policlinico Monteluce
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Perugia, Italy
135.312.39002 A. O. di Padova - Policlinico Universitario
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Padova, Italy
135.312.39023 P. O. di Piacenza
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Piacenza, Italy
135.312.39016 A. O. Ospedale Santa Corona
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Pietra Ligure (sv), Italy
135.312.39006 Ospedale Santa Chiara
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Pisa, Italy
135.312.39003 A. O. Arcispedale "Santa Maria Nuova"
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Reggio Emilia, Italy
135.312.39025 Università di Roma "La Sapienza"
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Roma, Italy
135.312.39001 A. O. Policlinico Umberto I
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Roma, Italy
135.312.39018 Ospedale S. Maria della Misericordia
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Udine, Italy
135.312.47001 Boehringer Ingelheim Investigational Site
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Bergen, Norway
135.312.31007 Medisch Spectrum Twente
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Enschede, Netherlands
135.312.39004 Ospedale Civile
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Vicenza, Italy
135.312.47006 Boehringer Ingelheim Investigational Site
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Tønsberg, Norway
135.312.47003 Boehringer Ingelheim Investigational Site
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Trondheim, Norway
135.312.48004 Medical University of Gdansk
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Gdansk, Poland
135.312.35102 Hospital de Santo António
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Porto, Portugal
135.312.48006 Wojewodship Specialistic Neuropsychiatric Centre in Opole
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Opole, Poland
135.312.48002 Dr. Anna Gostynska Wolski Hospital
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Warsaw, Poland
135.312.35106 Hospital de Santa Maria
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Lisboa, Portugal
135.312.35105 Hospital de São Sebastião, EPE
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Santa Maria da Feira, Portugal
135.312.42103 NEURON PLUS s.r.o
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Bratislava, Slovakia
135.312.42102 Hospital Levoca
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Levoca, Slovakia
135.312.34006 Boehringer Ingelheim Investigational Site
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Badalona / Barcelona, Spain
135.312.42105 Boehringer Ingelheim Investigational Site
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Trnava, Slovakia
135.312.34001 Boehringer Ingelheim Investigational Site
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Barcelona, Spain
135.312.34019 Boehringer Ingelheim Investigational Site
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Albacete, Spain
135.312.34002 Boehringer Ingelheim Investigational Site
🇪🇸
Barcelona, Spain
135.312.34003 Boehringer Ingelheim Investigational Site
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Barcelona, Spain
135.312.34011 Boehringer Ingelheim Investigational Site
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Bilbao, Spain
135.312.34009 Boehringer Ingelheim Investigational Site
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Madrid, Spain
135.312.34007 Boehringer Ingelheim Investigational Site
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Girona, Spain
135.312.34017 Boehringer Ingelheim Investigational Site
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Santiago de Compostela, Spain
135.312.34018 Boehringer Ingelheim Investigational Site
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Sevilla, Spain
135.312.46002 Boehringer Ingelheim Investigational Site
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Stockholm, Sweden
135.312.46007 Boehringer Ingelheim Investigational Site
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Lidköping, Sweden
135.312.46005 Boehringer Ingelheim Investigational Site
🇸🇪
Skövde, Sweden
135.312.46004 Boehringer Ingelheim Investigational Site
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Stockholm, Sweden
135.312.41002 Boehringer Ingelheim Investigational Site
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St. Gallen, Switzerland
135.312.44025 Boehringer Ingelheim Investigational Site
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Aberdeen, United Kingdom
135.312.41001 Boehringer Ingelheim Investigational Site
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Basel, Switzerland
135.312.44002 Boehringer Ingelheim Investigational Site
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Bournemouth, United Kingdom
135.312.44023 Boehringer Ingelheim Investigational Site
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Cambridge, United Kingdom
135.312.33014 Boehringer Ingelheim Investigational Site
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Grenoble cédex 9, France
135.312.33006 Boehringer Ingelheim Investigational Site
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Paris, France
135.312.33013 Boehringer Ingelheim Investigational Site
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Bordeaux cedex, France
135.312.34010 Boehringer Ingelheim Investigational Site
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Madrid, Spain
135.312.33019 Boehringer Ingelheim Investigational Site
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Limoges cedex 1, France
135.312.34020 Boehringer Ingelheim Investigational Site
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Madrid, Spain
135.312.34014 Boehringer Ingelheim Investigational Site
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Zaragoza, Spain
135.312.33023 Boehringer Ingelheim Investigational Site
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Pontoise, France
135.312.49009 Boehringer Ingelheim Investigational Site
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Wiesbaden, Germany
135.312.33012 Boehringer Ingelheim Investigational Site
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Toulouse cedex 9, France
135.312.49020 Boehringer Ingelheim Investigational Site
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Ludwigshafen am Rhein, Germany
135.312.49025 Boehringer Ingelheim Investigational Site
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Teupitz, Germany
135.312.42104 Jessenius Faculty of Medicine Commenius University
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Martin, Slovakia
135.312.43001 Boehringer Ingelheim Investigational Site
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Linz, Austria
135.312.32002 Boehringer Ingelheim Investigational Site
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Anderlecht, Belgium
135.312.48005 Dept. of Neurology, Regenerative and Cerebrovascular Disease
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Katowice, Poland
135.312.48001 Institute of Psychiatry & Neurology in Warsaw
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Warsaw, Poland
135.312.42101 Faculty Hospital
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Nitra, Slovakia