STudy to vAlidate telemetRic ECG Systems for firsT Dose Administration of Fingolimod (START)
START
A 1-week, Open-label, Multi-center Study to Explore Conduction Abnormalities During First Dose Administration of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis
1 other identifier
interventional
6,998
1 country
258
Brief Summary
This study evaluated bradycardiac events during first dose observation of fingolimod in MS patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 multiple-sclerosis
Started Apr 2012
Longer than P75 for phase_4 multiple-sclerosis
258 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 23, 2012
CompletedFirst Posted
Study publicly available on registry
April 25, 2012
CompletedStudy Start
First participant enrolled
April 29, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 12, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 12, 2016
CompletedResults Posted
Study results publicly available
September 23, 2019
CompletedSeptember 23, 2019
August 1, 2019
4.6 years
April 23, 2012
December 7, 2017
August 21, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Participants With 2nd or 3rd Degree Atrioventricular (AV) Block
AV Blocks/Heart block is an abnormal heart rhythm where the heart beats too slowly; the electrical signals that tell the heart to contract are partially intermittent (Type 2:1) or slowed (1st and 2nd degree) or blocked (3rd degree) between the upper chambers (atria) and the lower chambers (ventricles). In 2nd degree AV Blocks, electrical impulses are intermittent (type 2:1) or delayed w/ each subsequent heartbeat (Mobitz type I) until a beat fails to reach the ventricles entirely. This type of block often is physiologic and observed in a highly relaxed state \& during sleep. In 2nd degree AV Blocks type II, the atria electrical impulses are unable to reach the ventricles, a more serious condition. In 3rd degree AV Blocks (complete heart block), none of the electrical impulses reach either the atria or the ventricles. Patients can experience simultaneously both types of 2nd or 3rd degree AV Blocks without any symptoms.
baseline, during 6 hour monitoring post first dose observation
Number of Patients With Heart Rate Below 45 Beats Per Minute (BPM)
Number of patients with heart rate below 45 beats bpm in ECG during first dose observation
baseline during 6 hour monitoring post dose
Secondary Outcomes (3)
Number of Participants With Prolonged QTc Interval (Friderica)
baseline post-dose
Number of Participants With Bradyarrhythmic Electrocardiogram (ECG) Events
up to day 7
Number of Patients With Cardiac Adverse Events
7 days
Study Arms (1)
Fingolimod
EXPERIMENTALFingolimod 0.5 mg by mouth once daily for 7 days.
Interventions
Eligibility Criteria
You may qualify if:
- Subjects with relapsing remitting MS.
- Patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy.
- Patients who had been previously on 2nd line therapies. It was understood that these patients satisfied the above mentioned criteria listed under a. in the past.
- This also included patients, who were previously treated with fingolimod (regardless of whether or not they had already been treated within the START study) but discontinued treatment due to medical reasons.
- \- or patients with rapidly evolving severe RRMS (e.g. \> 2 relapses with disease progression in one year and \> 1 Gd-enhancing lesion or with a significant increase in T2 lesions compared to a recent MRI).
You may not qualify if:
- immunocompromised patients
- active infections
- pregnant or nursing women, women of childbearing potential unless using 2 reliable forms of contraception
- presence of malignancy (other than localized basal cell carcinoma of the skin).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (258)
Novartis Investigative Site
Ostfildern, Baden-Wurttemberg, 73760, Germany
Novartis Investigative Site
Munich, Bavaria, 81241, Germany
Novartis Investigative Site
Altenholz-Stift, Germany, 24161, Germany
Novartis Investigative Site
Cologne, North Rhine-Westphalia, 50937, Germany
Novartis Investigative Site
Flensburg, Schleswig-Holstein, 24939, Germany
Novartis Investigative Site
Aachen, 52062, Germany
Novartis Investigative Site
Aachen, 52074, Germany
Novartis Investigative Site
Aalen, 73430, Germany
Novartis Investigative Site
Aalen-Wasseralfingen, 73433, Germany
Novartis Investigative Site
Abensberg, 93326, Germany
Novartis Investigative Site
Achim, 28832, Germany
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Aichach, 86551, Germany
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Altenburg, 04600, Germany
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Alzenau in Unterfranken, 63755, Germany
Novartis Investigative Site
Andernach, 56626, Germany
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Asbach, 53567, Germany
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Aschaffenburg, 63739, Germany
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Augsburg, 86179, Germany
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Bad Berka, 99437, Germany
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Bad Hersfeld, 36251, Germany
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Bad Homburg, 61348, Germany
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Bad Honnef, 53604, Germany
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Bad Krozingen, 79189, Germany
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Bad Mergentheim, 97980, Germany
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Bad Saarow, 15526, Germany
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Bad Wildbad, 75323, Germany
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Bamberg, 96052, Germany
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Bayreuth, 95445, Germany
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Berg, 82335, Germany
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Bergisch Gladbach, 51429, Germany
Novartis Investigative Site
Berlin, 10178, Germany
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Berlin, 10365, Germany
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Berlin, 10437, Germany
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Berlin, 10713, Germany
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Berlin, 120999, Germany
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Berlin, 12101, Germany
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Berlin, 12163, Germany
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Berlin, 12351, Germany
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Berlin, 12587, Germany
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Berlin, 12621, Germany
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Berlin, 13347, Germany
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Berlin, 13353, Germany
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Berlin, 13465, Germany
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Berlin, 13507, Germany
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Berlin, 14059, Germany
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Berlin, 14163, Germany
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Berlin, 14169, Germany
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Bielefeld, 33602, Germany
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Bielefeld, 33647, Germany
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Bochum, 44787, Germany
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Bochum, 44789, Germany
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Bochum, 44791, Germany
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Bochum, 44795, Germany
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Bochum, 44869, Germany
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Bogen, 94327, Germany
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Bonn, 53111, Germany
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Borna, 04552, Germany
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Bottrop, 46236, Germany
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Böblingen, 71032, Germany
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Braunschweig, 38100, Germany
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Braunschweig, 38114, Germany
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Bremen, 28755, Germany
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Bruchsal, 76646, Germany
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Buchholz, 21244, Germany
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Buchholz in der Nordheide, 21244, Germany
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Butzbach, 35510, Germany
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Celle, 29223, Germany
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Chemnitz, 09117, Germany
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Cologne, 50674, Germany
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Cologne, 50935, Germany
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Cologne, 51109, Germany
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Delbrück, 33129, Germany
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Dessau, 06846, Germany
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Dillingen, 66763, Germany
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Dillingen, 89407, Germany
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Dortmund, 44135, Germany
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Dortmund, 44137, Germany
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Dresden, 01067, Germany
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Dresden, 01307, Germany
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Düren, 52351, Germany
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Düsseldorf, 40211, Germany
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Düsseldorf, 40225, Germany
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Düsseldorf, 40479, Germany
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Düsseldorf, 40625, Germany
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Eberswalde, 16225, Germany
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Eisenach, 99817, Germany
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Eisleben Lutherstadt, 06295, Germany
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Eltville, 65343, Germany
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Emden, 26721, Germany
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Emmendingen, 79312, Germany
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Erbach im Odenwald, 64711, Germany
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Erfurt, 99089, Germany
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Erfurt, 99096, Germany
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Erlangen, 91054, Germany
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Eschwege, 37269, Germany
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Essen, 45131, Germany
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Essen, 45138, Germany
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Essen, 45147, Germany
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Essen, 45257, Germany
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Frankfurt, 60313, Germany
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Frankfurt, 60590, Germany
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Frankfurt am Main, 60313, Germany
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Frankfurt am Main, 60594, Germany
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Freiburg im Breisgau, 79098, Germany
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Freiburg im Breisgau, 79106, Germany
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Friedrichshafen, 88048, Germany
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Fulda, 36037, Germany
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Fulda, 36043, Germany
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Gelnhausen, 63571, Germany
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Gelsenkirchen, 45879, Germany
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Gilching, 82205, Germany
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Gladenbach, 35075, Germany
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Göttingen, 37073, Germany
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Göttingen, 37075, Germany
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Greifswald, 17475, Germany
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Grevenbroich, 41515, Germany
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Griesheim, 64347, Germany
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Guelders, 47608, Germany
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Gummersbach, 51643, Germany
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Gütersloh, 33332, Germany
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Haar, 85540, Germany
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Hagen, 58095, Germany
Novartis Investigative Site
Halle, 06120, Germany
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Halle S, 06120, Germany
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Hamburg, 20099, Germany
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Hamburg, 20249, Germany
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Hamburg, 20354, Germany
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Hamburg, 22083, Germany
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Hamburg, 22179, Germany
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Hamburg, 22297, Germany
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Hamburg, 22523, Germany
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Hanover, 30161, Germany
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Hanover, 30171, Germany
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Hanover, 30625, Germany
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Heidelberg, 69120, Germany
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Heidenheim, 89518, Germany
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Herdecke, 58313, Germany
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Herford, 32049, Germany
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Herford, 32052, Germany
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Hildesheim, 31134, Germany
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Homburg, 66421, Germany
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Hoppegarten, 15366, Germany
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Ibbenbueren, 49477, Germany
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Idar-Oberstein, 55743, Germany
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Isselburg-Anholt, 46419, Germany
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Itzehoe, 25524, Germany
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Jena, 07740, Germany
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Jena, 07743, Germany
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Jülich, 52428, Germany
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Kaiserslautern, 67655, Germany
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Kaltenkirchen, 24568, Germany
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Kandel, 76870, Germany
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Karlstadt am Main, 97753, Germany
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Kassel, 34121, Germany
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Kiel, 24105, Germany
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Klingenmünster, 76889, Germany
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Koeln-Longerich, 50737, Germany
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Korbach, 34497, Germany
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Königsbrück, 01936, Germany
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Krefeld, 47800, Germany
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Krefeld, 47805, Germany
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Landshut, 84028, Germany
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Lappersdorf, 93138, Germany
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Leipzig, 04103, Germany
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Leipzig, 04157, Germany
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Leipzig, 04275, Germany
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Leipzig, 04299, Germany
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Leverkusen, 51375, Germany
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Lohr a. Main, 79816, Germany
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Ludwigshafen, 67059, Germany
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Ludwigshafen, 67063, Germany
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Lübeck, 23538, Germany
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Lüneburg, 21335, Germany
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Lünen, 44534, Germany
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Magdeburg, 39104, Germany
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Magdeburg, 39120, Germany
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Mannheim, 66163, Germany
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Mannheim, 68159, Germany
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Mannheim, 68161, Germany
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Marburg, 35039, Germany
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Meisenheim, 55590, Germany
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Minden, 32423, Germany
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Minden, 32429, Germany
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Mittweida, 09648, Germany
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Mosbach, 74821, Germany
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Mönchengladbach, 41063, Germany
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Mönchengladbach, 41239, Germany
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Mülheim, 45481, Germany
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München, 80331, Germany
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München, 81675, Germany
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München, 81829, Germany
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Münster, 48147, Germany
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Münster, 48149, Germany
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Nagold, 72202, Germany
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Naumburg, 06618, Germany
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Neu-Ulm, 89231, Germany
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Neuburg an der Donau, 86633, Germany
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Neuruppin, 16816, Germany
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Neusäß, 86356, Germany
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Neustadt an der Weinstraße, 67433, Germany
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Nordhausen, 99734, Germany
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Nuremberg, 90461, Germany
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Offenbach, 63069, Germany
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Oldenburg, 26122, Germany
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Oldenburg I. Holstein, 23758, Germany
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Osnabrück, 49074, Germany
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Osnabrück, 49076, Germany
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Osnabrück, 49078, Germany
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Öhringen, 74613, Germany
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Paderborn, 33098, Germany
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Papenburg, 26871, Germany
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Pforzheim, 75172, Germany
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Potsdam, 14471, Germany
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Prien am Chiemsee, 83209, Germany
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Quakenbrück, 49610, Germany
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Querfurt, 06268, Germany
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Ravensburg, 88212, Germany
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Recklinghausen, 45657, Germany
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Regensburg, 93059, Germany
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Remscheid, 42853, Germany
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Rostock, 18057, Germany
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Rüdersdorf, 15562, Germany
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Saarbrücken, 66113, Germany
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Saint Ingbert, 66386, Germany
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Sande, 26452, Germany
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Schwalmstadt-Treysa, 34613, Germany
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Schwerin, 19057, Germany
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Siegen, 57076, Germany
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Singen, 78224, Germany
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Sinsheim, 74889, Germany
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Solingen, 42719, Germany
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Stade, 21682, Germany
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Stadtroda, 07646, Germany
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Stralsund, 18439, Germany
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Stuttgart, 70174, Germany
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Stuttgart, 70176, Germany
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Stuttgart, 70178, Germany
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Stuttgart, 70182, Germany
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Telgte, 48291, Germany
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Teupitz, 15755, Germany
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Troisdorf, 53844, Germany
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Tübingen, 72076, Germany
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Ulm, 89073, Germany
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Ulm, 89081, Germany
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Unterhaching, 82008, Germany
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Wasserburg, 83512, Germany
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Wendlingen, 73240, Germany
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Wermsdorf, 04779, Germany
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Westerstede, 26655, Germany
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Westerstede/Oldenburg, 26655, Germany
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Wiesbaden, 65183, Germany
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Wiesbaden, 65191, Germany
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Wolfratshausen, 82515, Germany
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Wuppertal, 42103, Germany
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Wuppertal, 42283, Germany
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Würzburg, 97070, Germany
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Würzburg, 97080, Germany
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Zwickau, 08060, Germany
Related Publications (1)
Limmroth V, Ziemssen T, Lang M, Richter S, Wagner B, Haas J, Schmidt S, Gerbershagen K, Lassek C, Klotz L, Hoffmann O, Albert C, Schuh K, Baier-Ebert M, Wendt G, Schieb H, Hoyer S, Dechend R, Haverkamp W. Electrocardiographic assessments and cardiac events after fingolimod first dose - a comprehensive monitoring study. BMC Neurol. 2017 Jan 18;17(1):11. doi: 10.1186/s12883-016-0789-7.
PMID: 28100182DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
292 centers were initiated but 278 centers randomized patients.
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 23, 2012
First Posted
April 25, 2012
Study Start
April 29, 2012
Primary Completion
December 12, 2016
Study Completion
December 12, 2016
Last Updated
September 23, 2019
Results First Posted
September 23, 2019
Record last verified: 2019-08