Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01127750




Registration number
NCT01127750
Ethics application status
Date submitted
19/05/2010
Date registered
21/05/2010
Date last updated
23/02/2017

Titles & IDs
Public title
Tolerability and Safety and Health Outcomes in Relapsing Multiple Sclerosis (MS) Patients
Scientific 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
Secondary ID [1] 0 0
2010-019029-32
Secondary ID [2] 0 0
CFTY720D2316
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Relapsing Multiple Sclerosis 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: FTY720 -

Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Evaluate the safety and tolerability profile of FTY720 in patients with relapsing forms of MS
Timepoint [1] 0 0
4 months
Secondary outcome [1] 0 0
Incidence of macular edema
Timepoint [1] 0 0
4 months
Secondary outcome [2] 0 0
Incidence of bradyarrhythmic electrocardiograms (ECGs)
Timepoint [2] 0 0
4 months
Secondary outcome [3] 0 0
Patient reported outcomes indices in multiple sclerosis (PRIMUS), short form health survey-12, and treatment satisfaction questionnaire for medication (TSQM-9)
Timepoint [3] 0 0
4 months

Eligibility
Key inclusion criteria
* 18-65 years of age, must have relapsing MS
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2011
Sample size
Target
Accrual to date
Final
2417
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Novartis Investigative Site - Box Hill
Recruitment hospital [2] 0 0
Novartis Investigative Site - Heidelberg
Recruitment hospital [3] 0 0
Novartis Investigative Site - Kogarah
Recruitment hospital [4] 0 0
Novartis Investigative Site - Liverpool
Recruitment hospital [5] 0 0
Novartis Investigative Site - Woodville South
Recruitment postcode(s) [1] 0 0
3128 - Box Hill
Recruitment postcode(s) [2] 0 0
3084 - Heidelberg
Recruitment postcode(s) [3] 0 0
2217 - Kogarah
Recruitment postcode(s) [4] 0 0
2170 - Liverpool
Recruitment postcode(s) [5] 0 0
5011 - Woodville South
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Linz
Country [2] 0 0
Austria
State/province [2] 0 0
Vienna
Country [3] 0 0
Belgium
State/province [3] 0 0
Brugge
Country [4] 0 0
Belgium
State/province [4] 0 0
Bruxelles
Country [5] 0 0
Belgium
State/province [5] 0 0
Charleroi
Country [6] 0 0
Belgium
State/province [6] 0 0
Leuven
Country [7] 0 0
Belgium
State/province [7] 0 0
Melsbroek
Country [8] 0 0
Belgium
State/province [8] 0 0
Overpelt
Country [9] 0 0
Belgium
State/province [9] 0 0
Sijsele
Country [10] 0 0
Belgium
State/province [10] 0 0
Tinlot
Country [11] 0 0
Belgium
State/province [11] 0 0
Wilrijk
Country [12] 0 0
Canada
State/province [12] 0 0
Montreal
Country [13] 0 0
Canada
State/province [13] 0 0
Quebec
Country [14] 0 0
Canada
State/province [14] 0 0
Victoria
Country [15] 0 0
Czech Republic
State/province [15] 0 0
Praha 2
Country [16] 0 0
Czech Republic
State/province [16] 0 0
Teplice
Country [17] 0 0
Denmark
State/province [17] 0 0
Copenhagen
Country [18] 0 0
Denmark
State/province [18] 0 0
Århus
Country [19] 0 0
Finland
State/province [19] 0 0
Helsinki
Country [20] 0 0
Finland
State/province [20] 0 0
Turku
Country [21] 0 0
Germany
State/province [21] 0 0
Aachen
Country [22] 0 0
Germany
State/province [22] 0 0
Aalen
Country [23] 0 0
Germany
State/province [23] 0 0
Abensberg
Country [24] 0 0
Germany
State/province [24] 0 0
Achim
Country [25] 0 0
Germany
State/province [25] 0 0
Alzenau
Country [26] 0 0
Germany
State/province [26] 0 0
Aschaffenburg
Country [27] 0 0
Germany
State/province [27] 0 0
Attenberg
Country [28] 0 0
Germany
State/province [28] 0 0
Augsburg
Country [29] 0 0
Germany
State/province [29] 0 0
Bad Honnef
Country [30] 0 0
Germany
State/province [30] 0 0
Bad Krozingen
Country [31] 0 0
Germany
State/province [31] 0 0
Bad Mergentheim
Country [32] 0 0
Germany
State/province [32] 0 0
Bad Neustadt / Saale
Country [33] 0 0
Germany
State/province [33] 0 0
Bamberg
Country [34] 0 0
Germany
State/province [34] 0 0
Bayreuth
Country [35] 0 0
Germany
State/province [35] 0 0
Berlin
Country [36] 0 0
Germany
State/province [36] 0 0
Bielefeld
Country [37] 0 0
Germany
State/province [37] 0 0
Boblingen
Country [38] 0 0
Germany
State/province [38] 0 0
Bochum
Country [39] 0 0
Germany
State/province [39] 0 0
Bogen
Country [40] 0 0
Germany
State/province [40] 0 0
Bonn
Country [41] 0 0
Germany
State/province [41] 0 0
Braunschweig
Country [42] 0 0
Germany
State/province [42] 0 0
Buchholz
Country [43] 0 0
Germany
State/province [43] 0 0
Chemnitz
Country [44] 0 0
Germany
State/province [44] 0 0
Dillingen
Country [45] 0 0
Germany
State/province [45] 0 0
Dresden
Country [46] 0 0
Germany
State/province [46] 0 0
Düsseldorf
Country [47] 0 0
Germany
State/province [47] 0 0
Eisenach
Country [48] 0 0
Germany
State/province [48] 0 0
Emden
Country [49] 0 0
Germany
State/province [49] 0 0
Emmendingen
Country [50] 0 0
Germany
State/province [50] 0 0
Erbach
Country [51] 0 0
Germany
State/province [51] 0 0
Erfurt
Country [52] 0 0
Germany
State/province [52] 0 0
Erlangen
Country [53] 0 0
Germany
State/province [53] 0 0
Essen
Country [54] 0 0
Germany
State/province [54] 0 0
Frankfurt
Country [55] 0 0
Germany
State/province [55] 0 0
Freiburg
Country [56] 0 0
Germany
State/province [56] 0 0
Greifswald
Country [57] 0 0
Germany
State/province [57] 0 0
Grevenbroich
Country [58] 0 0
Germany
State/province [58] 0 0
Hamburg
Country [59] 0 0
Germany
State/province [59] 0 0
Hannover
Country [60] 0 0
Germany
State/province [60] 0 0
Heidelburg
Country [61] 0 0
Germany
State/province [61] 0 0
Herborn
Country [62] 0 0
Germany
State/province [62] 0 0
Herdecke
Country [63] 0 0
Germany
State/province [63] 0 0
Herne
Country [64] 0 0
Germany
State/province [64] 0 0
Homburg
Country [65] 0 0
Germany
State/province [65] 0 0
Itzehoe
Country [66] 0 0
Germany
State/province [66] 0 0
Jena
Country [67] 0 0
Germany
State/province [67] 0 0
Kaltenkirchen
Country [68] 0 0
Germany
State/province [68] 0 0
Kandel
Country [69] 0 0
Germany
State/province [69] 0 0
Karlsruhe
Country [70] 0 0
Germany
State/province [70] 0 0
Karlstadt
Country [71] 0 0
Germany
State/province [71] 0 0
Kassel
Country [72] 0 0
Germany
State/province [72] 0 0
Koeln
Country [73] 0 0
Germany
State/province [73] 0 0
Koln
Country [74] 0 0
Germany
State/province [74] 0 0
Krefeld
Country [75] 0 0
Germany
State/province [75] 0 0
Landshut
Country [76] 0 0
Germany
State/province [76] 0 0
Lappersdorf
Country [77] 0 0
Germany
State/province [77] 0 0
Leipzig
Country [78] 0 0
Germany
State/province [78] 0 0
Lengerich
Country [79] 0 0
Germany
State/province [79] 0 0
Lohr am Main
Country [80] 0 0
Germany
State/province [80] 0 0
Ludwigshafen
Country [81] 0 0
Germany
State/province [81] 0 0
Magdeburg
Country [82] 0 0
Germany
State/province [82] 0 0
Mainz
Country [83] 0 0
Germany
State/province [83] 0 0
Mannheim
Country [84] 0 0
Germany
State/province [84] 0 0
Marburg
Country [85] 0 0
Germany
State/province [85] 0 0
Mittweida
Country [86] 0 0
Germany
State/province [86] 0 0
Muenchen
Country [87] 0 0
Germany
State/province [87] 0 0
Muenster
Country [88] 0 0
Germany
State/province [88] 0 0
Munchen
Country [89] 0 0
Germany
State/province [89] 0 0
Mönchengladbach
Country [90] 0 0
Germany
State/province [90] 0 0
München
Country [91] 0 0
Germany
State/province [91] 0 0
Nagold
Country [92] 0 0
Germany
State/province [92] 0 0
Neu-Ulm
Country [93] 0 0
Germany
State/province [93] 0 0
Neuburg
Country [94] 0 0
Germany
State/province [94] 0 0
Neuruppin
Country [95] 0 0
Germany
State/province [95] 0 0
Nurnberg
Country [96] 0 0
Germany
State/province [96] 0 0
Oldenburg
Country [97] 0 0
Germany
State/province [97] 0 0
Osnabrück
Country [98] 0 0
Germany
State/province [98] 0 0
Ostfildern
Country [99] 0 0
Germany
State/province [99] 0 0
Pforzheim
Country [100] 0 0
Germany
State/province [100] 0 0
Potsdam
Country [101] 0 0
Germany
State/province [101] 0 0
Prien
Country [102] 0 0
Germany
State/province [102] 0 0
Regensburg
Country [103] 0 0
Germany
State/province [103] 0 0
Rostock
Country [104] 0 0
Germany
State/province [104] 0 0
Rudersdorf
Country [105] 0 0
Germany
State/province [105] 0 0
Rösrath
Country [106] 0 0
Germany
State/province [106] 0 0
Schwarzenbruck
Country [107] 0 0
Germany
State/province [107] 0 0
Schwendi
Country [108] 0 0
Germany
State/province [108] 0 0
Siegen
Country [109] 0 0
Germany
State/province [109] 0 0
Sigmaringen
Country [110] 0 0
Germany
State/province [110] 0 0
Sinsheim
Country [111] 0 0
Germany
State/province [111] 0 0
Stade
Country [112] 0 0
Germany
State/province [112] 0 0
Stuttgart
Country [113] 0 0
Germany
State/province [113] 0 0
Teupitz
Country [114] 0 0
Germany
State/province [114] 0 0
Tübingen
Country [115] 0 0
Germany
State/province [115] 0 0
Ulm
Country [116] 0 0
Germany
State/province [116] 0 0
Unterhaching
Country [117] 0 0
Germany
State/province [117] 0 0
Wendlingen
Country [118] 0 0
Germany
State/province [118] 0 0
Wermsdorf
Country [119] 0 0
Germany
State/province [119] 0 0
Westerstede
Country [120] 0 0
Germany
State/province [120] 0 0
Wiesbaden
Country [121] 0 0
Germany
State/province [121] 0 0
Wuppertal
Country [122] 0 0
Germany
State/province [122] 0 0
Würzburg
Country [123] 0 0
Greece
State/province [123] 0 0
Alexandroupolis
Country [124] 0 0
Greece
State/province [124] 0 0
Athens
Country [125] 0 0
Greece
State/province [125] 0 0
Thessaloniki
Country [126] 0 0
Hungary
State/province [126] 0 0
Budapest
Country [127] 0 0
Hungary
State/province [127] 0 0
Pecs
Country [128] 0 0
Hungary
State/province [128] 0 0
Szeged
Country [129] 0 0
Ireland
State/province [129] 0 0
Cork
Country [130] 0 0
Ireland
State/province [130] 0 0
Dublin 4
Country [131] 0 0
Ireland
State/province [131] 0 0
Dublin 9
Country [132] 0 0
Italy
State/province [132] 0 0
Acquaviva delle Fonti
Country [133] 0 0
Italy
State/province [133] 0 0
Asti
Country [134] 0 0
Italy
State/province [134] 0 0
Bergamo
Country [135] 0 0
Italy
State/province [135] 0 0
Bologna
Country [136] 0 0
Italy
State/province [136] 0 0
Cagliari
Country [137] 0 0
Italy
State/province [137] 0 0
Catania
Country [138] 0 0
Italy
State/province [138] 0 0
Foggia
Country [139] 0 0
Italy
State/province [139] 0 0
Milano
Country [140] 0 0
Italy
State/province [140] 0 0
Napoli
Country [141] 0 0
Italy
State/province [141] 0 0
Palermo
Country [142] 0 0
Italy
State/province [142] 0 0
Pozzilli
Country [143] 0 0
Italy
State/province [143] 0 0
Ravenna
Country [144] 0 0
Italy
State/province [144] 0 0
Roma
Country [145] 0 0
Italy
State/province [145] 0 0
Siena
Country [146] 0 0
Italy
State/province [146] 0 0
Udine
Country [147] 0 0
Italy
State/province [147] 0 0
Verona
Country [148] 0 0
Italy
State/province [148] 0 0
Vicenza
Country [149] 0 0
Italy
State/province [149] 0 0
Viterbo
Country [150] 0 0
Netherlands
State/province [150] 0 0
Amsterdam
Country [151] 0 0
Netherlands
State/province [151] 0 0
Blaricum
Country [152] 0 0
Netherlands
State/province [152] 0 0
Breda
Country [153] 0 0
Netherlands
State/province [153] 0 0
Enschede
Country [154] 0 0
Netherlands
State/province [154] 0 0
Gouda
Country [155] 0 0
Netherlands
State/province [155] 0 0
Tilburg
Country [156] 0 0
Norway
State/province [156] 0 0
Lillehammer
Country [157] 0 0
Norway
State/province [157] 0 0
Molde
Country [158] 0 0
Norway
State/province [158] 0 0
Stavanger
Country [159] 0 0
Poland
State/province [159] 0 0
Bydgoszcz
Country [160] 0 0
Poland
State/province [160] 0 0
Katowice
Country [161] 0 0
Poland
State/province [161] 0 0
Lodz
Country [162] 0 0
Portugal
State/province [162] 0 0
Amadora
Country [163] 0 0
Portugal
State/province [163] 0 0
Coimbra
Country [164] 0 0
Portugal
State/province [164] 0 0
Lisboa
Country [165] 0 0
Portugal
State/province [165] 0 0
Porto
Country [166] 0 0
Russian Federation
State/province [166] 0 0
Ekaterinburg
Country [167] 0 0
Russian Federation
State/province [167] 0 0
Kazan
Country [168] 0 0
Russian Federation
State/province [168] 0 0
Moscow
Country [169] 0 0
Russian Federation
State/province [169] 0 0
Nizhny Novgorod
Country [170] 0 0
Russian Federation
State/province [170] 0 0
S.-Petersburg
Country [171] 0 0
Russian Federation
State/province [171] 0 0
Samara
Country [172] 0 0
Russian Federation
State/province [172] 0 0
Smolensk
Country [173] 0 0
Russian Federation
State/province [173] 0 0
St. Petersburg
Country [174] 0 0
Slovakia
State/province [174] 0 0
Banska Bystrica
Country [175] 0 0
Slovakia
State/province [175] 0 0
Bratislava
Country [176] 0 0
Slovakia
State/province [176] 0 0
Trnava
Country [177] 0 0
Spain
State/province [177] 0 0
Barcelona
Country [178] 0 0
Spain
State/province [178] 0 0
El Palmar
Country [179] 0 0
Spain
State/province [179] 0 0
Madrid
Country [180] 0 0
Spain
State/province [180] 0 0
San Sebastian
Country [181] 0 0
Spain
State/province [181] 0 0
Santa Cruz de Tenerife
Country [182] 0 0
Spain
State/province [182] 0 0
Santiago de Compostela
Country [183] 0 0
Spain
State/province [183] 0 0
Valencia
Country [184] 0 0
Sweden
State/province [184] 0 0
Göteborg
Country [185] 0 0
Sweden
State/province [185] 0 0
Linköping
Country [186] 0 0
Sweden
State/province [186] 0 0
Umea
Country [187] 0 0
Switzerland
State/province [187] 0 0
Aarau
Country [188] 0 0
Switzerland
State/province [188] 0 0
Carouge
Country [189] 0 0
Switzerland
State/province [189] 0 0
Geneve
Country [190] 0 0
Switzerland
State/province [190] 0 0
Lausanne
Country [191] 0 0
Switzerland
State/province [191] 0 0
Lugano
Country [192] 0 0
Switzerland
State/province [192] 0 0
St. Gallen
Country [193] 0 0
Switzerland
State/province [193] 0 0
Zuerich
Country [194] 0 0
Turkey
State/province [194] 0 0
Antalya
Country [195] 0 0
Turkey
State/province [195] 0 0
Gaziantep
Country [196] 0 0
Turkey
State/province [196] 0 0
Istanbul
Country [197] 0 0
Turkey
State/province [197] 0 0
Samsun
Country [198] 0 0
Turkey
State/province [198] 0 0
Trabzon
Country [199] 0 0
United Kingdom
State/province [199] 0 0
Birmingham
Country [200] 0 0
United Kingdom
State/province [200] 0 0
Brighton
Country [201] 0 0
United Kingdom
State/province [201] 0 0
Dundee
Country [202] 0 0
United Kingdom
State/province [202] 0 0
Edinburgh
Country [203] 0 0
United Kingdom
State/province [203] 0 0
Essex
Country [204] 0 0
United Kingdom
State/province [204] 0 0
Great Yarmouth
Country [205] 0 0
United Kingdom
State/province [205] 0 0
Headington
Country [206] 0 0
United Kingdom
State/province [206] 0 0
Liverpool
Country [207] 0 0
United Kingdom
State/province [207] 0 0
London
Country [208] 0 0
United Kingdom
State/province [208] 0 0
Middlesborough
Country [209] 0 0
United Kingdom
State/province [209] 0 0
Newcastle Upon Tyne
Country [210] 0 0
United Kingdom
State/province [210] 0 0
Northampton
Country [211] 0 0
United Kingdom
State/province [211] 0 0
Norwick
Country [212] 0 0
United Kingdom
State/province [212] 0 0
Poole
Country [213] 0 0
United Kingdom
State/province [213] 0 0
Salford
Country [214] 0 0
United Kingdom
State/province [214] 0 0
Sheffield
Country [215] 0 0
United Kingdom
State/province [215] 0 0
Stoke on Trent
Country [216] 0 0
United Kingdom
State/province [216] 0 0
Swindon
Country [217] 0 0
United Kingdom
State/province [217] 0 0
Truro

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study will assess tolerability and safety and health outcomes in relapsing MS patients taking FTY720.
Trial website
https://clinicaltrials.gov/study/NCT01127750
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01127750