Clinical trial NCT01127750: Tolerability and Safety and Health Outcomes in Relapsing Multiple Sclerosis (MS) Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Relapsing Multiple Sclerosis
Keywords: Relapsing multiple sclerosis
MS
safety
tolerability
health outcomes
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-05-21
Enrollment: 2417
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will assess tolerability and safety and health outcomes in relapsing MS patients taking FTY720.


Eligibility criteria: 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.

Primary outcomes:
measure: Evaluate the safety and tolerability profile of FTY720 in patients with relapsing forms of MS
timeFrame: 4 months
Secondary outcomes:
measure: Incidence of macular edema
timeFrame: 4 months
measure: Incidence of bradyarrhythmic electrocardiograms (ECGs)
timeFrame: 4 months
measure: Patient reported outcomes indices in multiple sclerosis (PRIMUS), short form health survey-12, and treatment satisfaction questionnaire for medication (TSQM-9)
timeFrame: 4 months
Other outcomes:
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city: Heidelberg
country: Australia
facility: Novartis Investigative Site
city: Kogarah
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city: Bamberg
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facility: Novartis Investigative Site
city: Berlin
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facility: Novartis Investigative Site
city: Berlin
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facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
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facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novarris Investigative Site
city: Berlin
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facility: Novartis Investigative Site
city: Berlin
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facility: Novartis Investigative Site
city: Berlin
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city: Berlin
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facility: Novartis Investigative Site
city: Bielefeld
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city: Bielefeld
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city: Boblingen
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city: Bochum
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city: Bochum
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city: Bochum
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city: Bochum
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facility: Novaratis Investigative Site
city: Bogen
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city: Bonn
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city: Dillingen
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city: Dresden
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facility: Novartis Investigative Site
city: Düsseldorf
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facility: Novartis Investigative Site
city: Eisenach
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facility: Novartis Investigational Site
city: Emden
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facility: Novartis Investigative Site
city: Emmendingen
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city: Erbach
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facility: Novartis Investigative Site
city: Erfurt
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facility: Novartis Investigational Site
city: Erlangen
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facility: Novartis Investigational Site
city: Essen
country: Germany
facility: Novartis Investigative Site
city: Essen
country: Germany
facility: Novartis Investigational Site
city: Essen
country: Germany
facility: Novartis Investigative Site
city: Frankfurt
country: Germany
facility: Novartis Investigational Site
city: Frankfurt
country: Germany
facility: Novartis Investigational Site
city: Freiburg
country: Germany
facility: Novartis Investigative Site
city: Greifswald
country: Germany
facility: Novartis Investigational Site
city: Grevenbroich
country: Germany
facility: Novartis Investigational Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigational Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Hamburg
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facility: Novartis Investigational Site
city: Hamburg
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facility: Novartis Investigative Site
city: Hamburg
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facility: Novartis Investigative Site
city: Hannover
country: Germany
facility: Novartis Investigative Site
city: Hannover
country: Germany
facility: Novartis Investigative Site
city: Hannover
country: Germany
facility: Novartis Investigative Site
city: Heidelburg
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facility: Novartis Investigative Site
city: Herborn
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facility: Novartis Investigational Site
city: Herdecke
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facility: Novartis Investigational Site
city: Herne
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facility: Novartis Investigational Site
city: Homburg
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facility: Novartis Investigational Site
city: Itzehoe
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facility: Novartis Investigational Site
city: Jena
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facility: Novartis Investigational Site
city: Jena
country: Germany
facility: Novartis Investigational Site
city: Kaltenkirchen
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facility: Novartis Investigational Site
city: Kandel
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facility: Novartis Investigative Site
city: Karlsruhe
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facility: Novartis Investigational Site
city: Karlstadt
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city: Kassel
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facility: Novartis Investigational Site
city: Koeln
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facility: Novartis Investigative Site
city: Koln
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facility: Novartis Investigative Site
city: Koln
country: Germany
facility: Novartis Investigative Site
city: Krefeld
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facility: Neuroscience Research of the Berkshires
city: Landshut
country: Germany
facility: Novartis Investigational Site
city: Lappersdorf
country: Germany
facility: Novartis Investigational Site
city: Leipzig
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city: Lengerich
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city: Lohr am Main
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city: Ludwigshafen
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city: Magdeburg
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city: Mainz
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city: Mannheim
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city: Marburg
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city: Mittweida
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city: Muenchen
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city: Muenster
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city: Munchen
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city: Mönchengladbach
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city: München
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city: München
country: Germany
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city: München
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city: Nagold
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city: Neu-Ulm
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city: Neuburg
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city: Neuruppin
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city: Nurnberg
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city: Oldenburg
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city: Osnabrück
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city: Ostfildern
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city: Pforzheim
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city: Potsdam
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city: Prien
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city: Regensburg
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city: Rostock
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city: Rudersdorf
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city: Rösrath
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city: Schwarzenbruck
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city: Schwendi
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city: Siegen
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city: Sigmaringen
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city: Sinsheim
country: Germany
facility: Novartis Investigational Site
city: Stade
country: Germany
facility: Novartis Investigative Site
city: Stuttgart
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city: Stuttgart
country: Germany
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city: Stuttgart
country: Germany
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city: Stuttgart
country: Germany
facility: Novartis Investigational Site
city: Teupitz
country: Germany
facility: Novartis Investigational Site
city: Tübingen
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facility: Novartis Investigational Site
city: Ulm
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city: Unterhaching
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city: Wendlingen
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city: Wermsdorf
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city: Westerstede
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city: Wiesbaden
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city: Wiesbaden
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facility: Novartis Investigative Site
city: Wuppertal
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facility: Novartis Investigational Site
city: Würzburg
country: Germany
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city: Alexandroupolis
country: Greece
facility: Novartis Investigational Site
city: Athens
country: Greece
facility: Novartis Investigational Site
city: Athens
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facility: Novartis Investigational Site
city: Thessaloniki
country: Greece
facility: Novartis Investigational Site
city: Thessaloniki
country: Greece
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city: Budapest
country: Hungary
facility: Novartis Investigational Site
city: Budapest
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country: Ireland
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country: Russian Federation
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city: Kazan
country: Russian Federation
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city: Moscow
country: Russian Federation
facility: Novartis Investigational Site
city: Moscow
country: Russian Federation
facility: Novartis Investigational Site
city: Nizhny Novgorod
country: Russian Federation
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country: Russian Federation
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city: S.-Petersburg
country: Russian Federation
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city: Samara
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city: Smolensk
country: Russian Federation
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city: St. Petersburg
country: Russian Federation
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city: Banska Bystrica
country: Slovakia
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country: Slovakia
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city: Trnava
country: Slovakia
facility: Novartis Investigational Site
city: Barcelona
country: Spain
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city: Barcelona
country: Spain
facility: Novartis Investigational Site
city: El Palmar
country: Spain
facility: Novartis Investigational Site
city: Madrid
country: Spain
facility: Novartis Investigational Site
city: Madrid
country: Spain
facility: Novartis Investigational Site
city: San Sebastian
country: Spain
facility: Novartis Investigational Site
city: Santa Cruz de Tenerife
country: Spain
facility: Novartis Investigational Site
city: Santiago de Compostela
country: Spain
facility: Novartis Investigational Site
city: Valencia
country: Spain
facility: Novartis Investigational Site
city: Göteborg
country: Sweden
facility: Novartis Investigational Site
city: Linköping
country: Sweden
facility: Novartis Investigational Site
city: Umea
country: Sweden
facility: Novartis Investigational Site
city: Aarau
country: Switzerland
facility: Novartis Investigational Site
city: Carouge
country: Switzerland
facility: Novartis Investigational Site
city: Geneve
country: Switzerland
facility: Novartis Investigational Site
city: Lausanne
country: Switzerland
facility: Novartis Investigational Site
city: Lugano
country: Switzerland
facility: Novartis Investigational Site
city: St. Gallen
country: Switzerland
facility: Novartis Investigational Site
city: Zuerich
country: Switzerland
facility: Novartis Investigational Site
city: Antalya
country: Turkey
facility: Novartis Investigational Site
city: Gaziantep
country: Turkey
facility: Novartis Investigational Site
city: Istanbul
country: Turkey
facility: Novartis Investigational Site
city: Istanbul
country: Turkey
facility: Novartis Investigational Site
city: Samsun
country: Turkey
facility: Novartis Investigational Site
city: Trabzon
country: Turkey
facility: Novartis Investigational Site
city: Birmingham
country: United Kingdom
facility: Novartis Investigational Site
city: Brighton
country: United Kingdom
facility: Novartis Investigational Site
city: Dundee
country: United Kingdom
facility: Novartis Investigational Site
city: Edinburgh
country: United Kingdom
facility: Novartis Investigational Site
city: Essex
country: United Kingdom
facility: Novartis Investigational Site
city: Great Yarmouth
country: United Kingdom
facility: Novartis Investigational Site
city: Headington
country: United Kingdom
facility: Novartis Investigational Site
city: Liverpool
country: United Kingdom
facility: Novartis Investigational Site
city: London
country: United Kingdom
facility: Novartis Investigational Site
city: London
country: United Kingdom
facility: Novartis Investigational Site
city: Middlesborough
country: United Kingdom
facility: Novartis Investigational Site
city: Newcastle Upon Tyne
country: United Kingdom
facility: Novartis Investigational Site
city: Northampton
country: United Kingdom
facility: Novartis Investigational Site
city: Norwick
country: United Kingdom
facility: Novartis Investigational Site
city: Poole
country: United Kingdom
facility: Novartis Investigational Site
city: Salford
country: United Kingdom
facility: Novartis Investigational Site
city: Sheffield
country: United Kingdom
facility: Novartis Investigational Site
city: Stoke on Trent
country: United Kingdom
facility: Novartis Investigational Site
city: Swindon
country: United Kingdom
facility: Novartis Investigational Site
city: Truro
country: United Kingdom
facility: Novartis Investigational Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: 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 phase 3b, open-label study. J Neurol. 2014 Feb;261(2):267-76. doi: 10.1007/s00415-013-7115-8. Epub 2013 Nov 13.