Relapsing Multiple Sclerosis Clinical Trial
Official title:
A 4-month, Open-label, Multi-center Study to Explore Tolerability and Safety and Health Outcomes of FTY720 in Patients With Relapsing Forms of Multiple Sclerosis
| Verified date | February 2017 |
| Source | Novartis |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This study will assess tolerability and safety and health outcomes in relapsing MS patients taking FTY720.
| Status | Completed |
| Enrollment | 2417 |
| Est. completion date | October 2011 |
| Est. primary completion date | October 2011 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility |
Inclusion Criteria: - 18-65 years of age, must have relapsing MS Exclusion Criteria: - Patients with a type of MS that is not relapsing - Patients with history of chronic immune disease - Patients with a history of certain cancers - Diabetic patients with certain eye disorders - Patients who are on certain immunosuppressive medications or heart medications - Patients with certain heart conditions - Patients with certain lung conditions Other protocol-defined inclusion/exclusion criteria may apply. |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Novartis Investigative Site | Box Hill | |
| Australia | Novartis Investigative Site | Heidelberg | |
| Australia | Novartis Investigative Site | Kogarah | |
| Australia | Novartis Investigative Site | Liverpool | |
| Australia | Novartis Investigative Site | Woodville South | |
| Austria | Novartis Investigational Site | Linz | |
| Austria | Novartis Investigational Site | Vienna | |
| Austria | Novartis Investigational Site | Vienna | |
| Belgium | Novartis Investigational Site | Brugge | |
| Belgium | Novartis Investigational Site | Bruxelles | |
| Belgium | Novartis Investigational Site | Bruxelles | |
| Belgium | Novartis Investigational Site | Charleroi | |
| Belgium | Novartis Investigational Site | Leuven | |
| Belgium | Novartis Investigational Site | Melsbroek | |
| Belgium | Novartis Investigational Site | Overpelt | |
| Belgium | Novartis Investigational Site | Sijsele | |
| Belgium | Novartis Investigational Site | Tinlot | |
| Belgium | Novartis Investigational Site | Wilrijk | |
| Canada | Novartis Investigational Site | Montreal | |
| Canada | Novartis Investigational Site | Quebec | |
| Canada | Novartis Investigational Site | Victoria | |
| Czech Republic | Novartis Investigational Site | Praha 2 | |
| Czech Republic | Novartis Investigational Site | Teplice | |
| Denmark | Novartis Investigational Site | Århus | |
| Denmark | Novartis Investigational Site | Copenhagen | |
| Finland | Novartis Investigational Site | Helsinki | |
| Finland | Novartis Investigational Site | Turku | |
| Germany | Novartis Investigational Site | Aachen | |
| Germany | Novartis Investigative Site | Aachen | |
| Germany | Novartis Investigational Site | Aalen | |
| Germany | Novartis Investigational Site | Abensberg | |
| Germany | Novartis Investigational Site | Achim | |
| Germany | Novartis Investigational Site | Alzenau | |
| Germany | Novartis Investigational Site | Aschaffenburg | |
| Germany | Novartis Investigational Site | Attenberg | |
| Germany | Novartis Investigational Site | Augsburg | |
| Germany | Novartis Investigational Site | Bad Honnef | |
| Germany | Novartis Investigational Site | Bad Krozingen | |
| Germany | Novartis Investigative Site | Bad Mergentheim | |
| Germany | Novartis Investigational Site | Bad Neustadt / Saale | |
| Germany | Novartis Investigational Site | Bamberg | |
| Germany | Novartis Investigational Site | Bamberg | |
| Germany | Novartis Investigative Site | Bayreuth | |
| Germany | Novarris Investigative Site | Berlin | |
| Germany | Novartis Investigative Site | Berlin | |
| Germany | Novartis Investigative Site | Berlin | |
| Germany | Novartis Investigative Site | Berlin | |
| Germany | Novartis Investigative Site | Berlin | |
| Germany | Novartis Investigative Site | Berlin | |
| Germany | Novartis Investigative Site | Berlin | |
| Germany | Novartis Investigative Site | Berlin | |
| Germany | Novartis Investigative Site | Berlin | |
| Germany | Novartis Investigative Site | Berlin | |
| Germany | Novartis Investigative Site | Berlin | |
| Germany | Novartis Investigative Site | Berlin | |
| Germany | Novartis Investigative Site | Berlin | |
| Germany | Novartis Investigative Site | Berlin | |
| Germany | Novartis Investigative Site | Bielefeld | |
| Germany | Novartis Investigative Site | Bielefeld | |
| Germany | Novartis Investigative Site | Bielefeld | |
| Germany | Novartis Investigative Site | Boblingen | |
| Germany | Novaratis Investigative Site | Bochum | |
| Germany | Novartis Investigational Site | Bochum | |
| Germany | Novartis Investigational Site | Bochum | |
| Germany | Novartis Investigative Site | Bochum | |
| Germany | Novartis Investigational Site | Bogen | |
| Germany | Novartis Investigative Site | Bonn | |
| Germany | Novartis Investigative Site | Bonn | |
| Germany | Novartis Investigational Site | Braunschweig | |
| Germany | Novartis Investigational Site | Buchholz | |
| Germany | Novartis Investigational Site | Chemnitz | |
| Germany | Novartis Investigational Site | Dillingen | |
| Germany | Novartis Investigative Site | Dresden | |
| Germany | Novartis Investigative Site | Düsseldorf | |
| Germany | Novartis Investigational Site | Eisenach | |
| Germany | Novartis Investigative Site | Emden | |
| Germany | Novartis Investigational Site | Emmendingen | |
| Germany | Novartis Investigative Site | Erbach | |
| Germany | Novartis Investigational Site | Erfurt | |
| Germany | Novartis Investigational Site | Erlangen | |
| Germany | Novartis Investigational Site | Essen | |
| Germany | Novartis Investigative Site | Essen | |
| Germany | Novartis Investigative Site | Essen | |
| Germany | Novartis Investigational Site | Frankfurt | |
| Germany | Novartis Investigational Site | Frankfurt | |
| Germany | Novartis Investigative Site | Freiburg | |
| Germany | Novartis Investigational Site | Greifswald | |
| Germany | Novartis Investigational Site | Grevenbroich | |
| Germany | Novartis Investigational Site | Hamburg | |
| Germany | Novartis Investigational Site | Hamburg | |
| Germany | Novartis Investigative Site | Hamburg | |
| Germany | Novartis Investigative Site | Hamburg | |
| Germany | Novartis Investigative Site | Hamburg | |
| Germany | Novartis Investigative Site | Hamburg | |
| Germany | Novartis Investigative Site | Hamburg | |
| Germany | Novartis Investigative Site | Hamburg | |
| Germany | Novartis Investigative Site | Hamburg | |
| Germany | Novartis Investigative Site | Hannover | |
| Germany | Novartis Investigative Site | Hannover | |
| Germany | Novartis Investigative Site | Hannover | |
| Germany | Novartis Investigative Site | Heidelburg | |
| Germany | Novartis Investigational Site | Herborn | |
| Germany | Novartis Investigational Site | Herdecke | |
| Germany | Novartis Investigational Site | Herne | |
| Germany | Novartis Investigational Site | Homburg | |
| Germany | Novartis Investigational Site | Itzehoe | |
| Germany | Novartis Investigational Site | Jena | |
| Germany | Novartis Investigational Site | Jena | |
| Germany | Novartis Investigational Site | Kaltenkirchen | |
| Germany | Novartis Investigative Site | Kandel | |
| Germany | Novartis Investigational Site | Karlsruhe | |
| Germany | Novartis Investigational Site | Karlstadt | |
| Germany | Novartis Investigational Site | Kassel | |
| Germany | Novartis Investigative Site | Koeln | |
| Germany | Novartis Investigative Site | Koln | |
| Germany | Novartis Investigative Site | Koln | |
| Germany | Neuroscience Research of the Berkshires | Krefeld | |
| Germany | Novartis Investigational Site | Landshut | |
| Germany | Novartis Investigational Site | Lappersdorf | |
| Germany | Novartis Investigational Site | Leipzig | |
| Germany | Novartis Investigative Site | Lengerich | |
| Germany | Novartis Investigational Site | Lohr am Main | |
| Germany | Novartis Investigational Site | Ludwigshafen | |
| Germany | Novartis Investigative Site | Ludwigshafen | |
| Germany | Novartis Investigative Site | Magdeburg | |
| Germany | Novartis Investigative Site | Mainz | |
| Germany | Novartis Investigational Site | Mannheim | |
| Germany | Novartis Investigational Site | Marburg | |
| Germany | Novartis Investigational Site | Marburg | |
| Germany | Novartis Investigational Site | Mittweida | |
| Germany | Novartis Investigational Site | Mönchengladbach | |
| Germany | Novartis Investigational Site | Muenchen | |
| Germany | Novartis Investigational Site | Muenchen | |
| Germany | Novartis Investigational Site | Muenster | |
| Germany | Novartis Investigational Site | Munchen | |
| Germany | Novartis Investigational Site | München | |
| Germany | Novartis Investigational Site | München | |
| Germany | Novartis Investigative Site | München | |
| Germany | Novartis Investigational Site | Nagold | |
| Germany | Novartis Investigational Site | Neu-Ulm | |
| Germany | Novartis Investigational Site | Neuburg | |
| Germany | Novartis Investigational Site | Neuruppin | |
| Germany | Novartis Investigational Site | Nurnberg | |
| Germany | Novartis Investigative Site | Oldenburg | |
| Germany | Novartis Investigational Site | Osnabrück | |
| Germany | Novartis Investigational Site | Ostfildern | |
| Germany | Novartis Investigational Site | Pforzheim | |
| Germany | Novartis Investigational Site | Potsdam | |
| Germany | Novartis Investigational Site | Potsdam | |
| Germany | Novartis Investigational Site | Prien | |
| Germany | Novartis Investigational Site | Regensburg | |
| Germany | Novartis Investigational Site | Rösrath | |
| Germany | Novartis Investigational Site | Rostock | |
| Germany | Novartis Investigative Site | Rudersdorf | |
| Germany | Novartis Investigational Site | Schwarzenbruck | |
| Germany | Novartis Investigative Site | Schwendi | |
| Germany | Novartis Investigative Site | Siegen | |
| Germany | Novartis Investigational Site | Sigmaringen | |
| Germany | Novartis Investigational Site | Sinsheim | |
| Germany | Novartis Investigative Site | Stade | |
| Germany | Novartis Investigational Site | Stuttgart | |
| Germany | Novartis Investigational Site | Stuttgart | |
| Germany | Novartis Investigative Site | Stuttgart | |
| Germany | Novartis Investigative Site | Stuttgart | |
| Germany | Novartis Investigational Site | Teupitz | |
| Germany | Novartis Investigational Site | Tübingen | |
| Germany | Novartis Investigative Site | Ulm | |
| Germany | Novartis Investigational Site | Unterhaching | |
| Germany | Novartis Investigational Site | Wendlingen | |
| Germany | Novartis Investigational Site | Wermsdorf | |
| Germany | Novartis Investigational Site | Westerstede | |
| Germany | Novartis Investigational Site | Wiesbaden | |
| Germany | Novartis Investigative Site | Wiesbaden | |
| Germany | Novartis Investigational Site | Wuppertal | |
| Germany | Novartis Investigational Site | Würzburg | |
| Greece | Novartis Investigational Site | Alexandroupolis | |
| Greece | Novartis Investigational Site | Athens | |
| Greece | Novartis Investigational Site | Athens | |
| Greece | Novartis Investigational Site | Thessaloniki | |
| Greece | Novartis Investigational Site | Thessaloniki | |
| Hungary | Novartis Investigational Site | Budapest | |
| Hungary | Novartis Investigational Site | Budapest | |
| Hungary | Novartis Investigational Site | Budapest | |
| Hungary | Novartis Investigational Site | Pecs | |
| Hungary | Novartis Investigational Site | Szeged | |
| Ireland | Novartis Investigational Site | Cork | |
| Ireland | Novartis Investigational Site | Dublin 4 | |
| Ireland | Novartis Investigational Site | Dublin 9 | |
| Italy | Novartis Investigative Site | Acquaviva delle Fonti | |
| Italy | Novartis Investigative SIte | Asti | |
| Italy | Novartis Investigative Site | Bergamo | |
| Italy | Novartis Investigative Site | Bologna | |
| Italy | Novartis Investigative Site | Cagliari | |
| Italy | Novartis Investigative Site | Catania | |
| Italy | Novartis Investigational Site | Foggia | |
| Italy | Novartis Investigative Site | Foggia | |
| Italy | Novartis Investigative Site | Milano | |
| Italy | Novartis Investigational Site | Napoli | |
| Italy | Novartis Investigational Site | Napoli | |
| Italy | Novartis Investigative Site | Napoli | |
| Italy | Novartis Investigative Site | Palermo | |
| Italy | Novartis Investigative Site | Pozzilli | |
| Italy | Novartis Investigative Site | Ravenna | |
| Italy | Novartis Investigational Site | Roma | |
| Italy | Novartis Investigational Site | Roma | |
| Italy | Novartis Investigational Site | Roma | |
| Italy | Novartis Investigational Site | Roma | |
| Italy | Novartis Investigative Site | Siena | |
| Italy | Novartis Investigative Site | Udine | |
| Italy | Novartis Investigative Site | Verona | |
| Italy | Novartis Investigative Site | Vicenza | |
| Italy | Novartis Investigative Site | Viterbo | |
| Netherlands | Novartis Investigational Site | Amsterdam | |
| Netherlands | Novartis Investigational Site | Amsterdam | |
| Netherlands | Novartis Investigational Site | Blaricum | |
| Netherlands | Novartis Investigational Site | Breda | |
| Netherlands | Novartis Investigational Site | Enschede | |
| Netherlands | Novartis Investigational Site | Gouda | |
| Netherlands | Novartis Investigational Site | Tilburg | |
| Norway | Novartis Investigational Site | Lillehammer | |
| Norway | Novartis Investigational Site | Molde | |
| Norway | Novartis Investigational Site | Stavanger | |
| Poland | Novartis Investigational Site | Bydgoszcz | |
| Poland | Novartis Investigational Site | Katowice | |
| Poland | Novartis Investigational Site | Lodz | |
| Portugal | Novartis Investigational Site | Amadora | |
| Portugal | Novartis Investigational Site | Coimbra | |
| Portugal | Novartis Investigational Site | Lisboa | |
| Portugal | Novartis Investigational Site | Porto | |
| Portugal | Novartis Investigational Site | Porto | |
| Russian Federation | Novartis Investigational Site | Ekaterinburg | |
| Russian Federation | Novartis Investigational Site | Kazan | |
| Russian Federation | Novartis Investigational Site | Kazan | |
| Russian Federation | Novartis Investigational Site | Moscow | |
| Russian Federation | Novartis Investigational Site | Moscow | |
| Russian Federation | Novartis Investigational Site | Moscow | |
| Russian Federation | Novartis Investigational Site | Nizhny Novgorod | |
| Russian Federation | Novartis Investigational Site | Nizhny Novgorod | |
| Russian Federation | Novartis Investigational Site | S.-Petersburg | |
| Russian Federation | Novartis Investigational Site | Samara | |
| Russian Federation | Novartis Investigational Site | Smolensk | |
| Russian Federation | Novartis Investigational Site | St. Petersburg | |
| Slovakia | Novartis Investigational Site | Banska Bystrica | |
| Slovakia | Novartis Investigational Site | Bratislava | |
| Slovakia | Novartis Investigational Site | Trnava | |
| Spain | Novartis Investigational Site | Barcelona | |
| Spain | Novartis Investigational Site | Barcelona | |
| Spain | Novartis Investigational Site | El Palmar | |
| Spain | Novartis Investigational Site | Madrid | |
| Spain | Novartis Investigational Site | Madrid | |
| Spain | Novartis Investigational Site | San Sebastian | |
| Spain | Novartis Investigational Site | Santa Cruz de Tenerife | |
| Spain | Novartis Investigational Site | Santiago de Compostela | |
| Spain | Novartis Investigational Site | Valencia | |
| Sweden | Novartis Investigational Site | Göteborg | |
| Sweden | Novartis Investigational Site | Linköping | |
| Sweden | Novartis Investigational Site | Umea | |
| Switzerland | Novartis Investigational Site | Aarau | |
| Switzerland | Novartis Investigational Site | Carouge | |
| Switzerland | Novartis Investigational Site | Geneve | |
| Switzerland | Novartis Investigational Site | Lausanne | |
| Switzerland | Novartis Investigational Site | Lugano | |
| Switzerland | Novartis Investigational Site | St. Gallen | |
| Switzerland | Novartis Investigational Site | Zuerich | |
| Turkey | Novartis Investigational Site | Antalya | |
| Turkey | Novartis Investigational Site | Gaziantep | |
| Turkey | Novartis Investigational Site | Istanbul | |
| Turkey | Novartis Investigational Site | Istanbul | |
| Turkey | Novartis Investigational Site | Samsun | |
| Turkey | Novartis Investigational Site | Trabzon | |
| United Kingdom | Novartis Investigational Site | Birmingham | |
| United Kingdom | Novartis Investigational Site | Brighton | |
| United Kingdom | Novartis Investigational Site | Dundee | |
| United Kingdom | Novartis Investigational Site | Edinburgh | |
| United Kingdom | Novartis Investigational Site | Essex | |
| United Kingdom | Novartis Investigational Site | Great Yarmouth | |
| United Kingdom | Novartis Investigational Site | Headington | |
| United Kingdom | Novartis Investigational Site | Liverpool | |
| United Kingdom | Novartis Investigational Site | London | |
| United Kingdom | Novartis Investigational Site | London | |
| United Kingdom | Novartis Investigational Site | Middlesborough | |
| United Kingdom | Novartis Investigational Site | Newcastle Upon Tyne | |
| United Kingdom | Novartis Investigational Site | Northampton | |
| United Kingdom | Novartis Investigational Site | Norwick | |
| United Kingdom | Novartis Investigational Site | Poole | |
| United Kingdom | Novartis Investigational Site | Salford | |
| United Kingdom | Novartis Investigational Site | Sheffield | |
| United Kingdom | Novartis Investigational Site | Stoke on Trent | |
| United Kingdom | Novartis Investigational Site | Swindon | |
| United Kingdom | Novartis Investigational Site | Truro |
| Lead Sponsor | Collaborator |
|---|---|
| Novartis |
Australia, Austria, Belgium, Canada, Czech Republic, Denmark, Finland, Germany, Greece, Hungary, Ireland, Italy, Netherlands, Norway, Poland, Portugal, Russian Federation, Slovakia, Spain, Sweden, Switzerland, Turkey, United Kingdom,
Gold R, Comi G, Palace J, Siever A, Gottschalk R, Bijarnia M, von Rosenstiel P, Tomic D, Kappos L; FIRST Study Investigators.. Assessment of cardiac safety during fingolimod treatment initiation in a real-world relapsing multiple sclerosis population: a p — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Evaluate the safety and tolerability profile of FTY720 in patients with relapsing forms of MS | 4 months | ||
| Secondary | Incidence of macular edema | 4 months | ||
| Secondary | Incidence of bradyarrhythmic electrocardiograms (ECGs) | 4 months | ||
| Secondary | Patient reported outcomes indices in multiple sclerosis (PRIMUS), short form health survey-12, and treatment satisfaction questionnaire for medication (TSQM-9) | 4 months |
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