Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

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/NCT00662649




Registration number
NCT00662649
Ethics application status
Date submitted
17/04/2008
Date registered
21/04/2008
Date last updated
12/07/2012

Titles & IDs
Public title
Long-term Efficacy and Safety of Fingolimod (FTY720) in Patients With Relapsing-remitting Multiple Sclerosis
Scientific title
An Extension of the 24-month, Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing Efficacy and Safety of Fingolimod (FTY720) 1.25 mg and 0.5 mg Administered Orally Once Daily Versus Placebo in Patients With Relapsing-remitting Multiple Sclerosis
Secondary ID [1] 0 0
2007-004122-24
Secondary ID [2] 0 0
CFTY720D2301E1
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Fingolimod 0.5 mg
Treatment: Drugs - Fingolimod 1.25 mg

Experimental: Fingolimod 1.25 mg - Patients continued the same dose to which they had been randomized in the Core study (CFTY720D2301/NCT00289978), fingolimod 1.25 mg/day, in this Extension study.

Experimental: Fingolimod 0.5 mg - Patients continued the same dose to which they had been randomized in the Core study, fingolimod 0.5 mg/day, in this Extension study.

Experimental: Placebo-fingolimod - Patients randomized to placebo in the Core study were re randomized to fingolimod (either 0.5 or 1.25 mg/day) in this Extension study.

Experimental: Placebo-fingolimod 1.25 mg - Patients randomized to placebo in the Core study were re randomized to fingolimod 1.25 mg/day in this Extension study.

Experimental: Placebo-fingolimod 0.5 mg - Patients randomized to placebo in the Core study were re randomized to fingolimod 0.5 mg/day in this Extension study.


Treatment: Drugs: Fingolimod 0.5 mg
Patients self-administered fingolimod 0.5 mg capsules orally once daily.

Treatment: Drugs: Fingolimod 1.25 mg
Patients self-administered fingolimod 1.25 mg capsules orally once daily.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Annualized Aggregate Relapse Rate (ARR) During Months 0 to End of Study(Core [CFTY720D2301/NCT00289978] and Extension Study)
Timepoint [1] 0 0
Months 0 to end of study (maximum up to 60 months)
Primary outcome [2] 0 0
Time to First Confirmed Relapse up to End of Study: Kaplan-Meier Estimate of Percentage of Patients Relapse-free
Timepoint [2] 0 0
Core baseline to end of study (maximum up to 60 months)
Primary outcome [3] 0 0
Annualized Aggregate Relapse Rate (ARR) During Months 0-24 (Core Study) and Months 24-48 (Extension Study)
Timepoint [3] 0 0
Months 0-24 (core study) and Months 24-48 (extension study)
Primary outcome [4] 0 0
Change (Expressed as Ratio) in the Annualized Aggregate Relapse Rate (ARR) From Months 0-24 (Core Study) to Months 24-48 (Extension Study)
Timepoint [4] 0 0
Months 0-24 (core study) and Months 24-48 (extension study)
Secondary outcome [1] 0 0
Change in Mean Number of New or Newly Enlarged T2 Magnetic Resonance Imaging (MRI) Lesions During Months 0-24 (Core Study) and Months 24-48 (Extension Study)
Timepoint [1] 0 0
Months 0-24 (core study) and Months 24-48 (extension study)
Secondary outcome [2] 0 0
Percentage of Patients Free of New or Newly Enlarged T2 Magnetic Resonance Imaging (MRI) Lesions During Months 0-24 (Core Study) and Months 24-48 (Extension Study)
Timepoint [2] 0 0
Months 0-24 (core study) and Months 24-48 (extension study)
Secondary outcome [3] 0 0
Percent Change in Brain Volume From Month 0 to Month 24 (Core Study) and From Month 24 to Month 48 (Extension Study)
Timepoint [3] 0 0
Months 0-24 (core study) and Months 24-48 (extension study)
Secondary outcome [4] 0 0
Percent Change in Brain Volume From Month 0 End of Study (Core and Extension Study)
Timepoint [4] 0 0
Months 0 to end of study (maximum up to 60 months)
Secondary outcome [5] 0 0
Time to First 3-month Confirmed Disability Progression up to End of Study Based on Expanded Disability Status Scale (EDSS): Kaplan-Meier Estimate of Percentage of Patients Free of Disability Progression
Timepoint [5] 0 0
Core baseline to end of study (maximum up to 60 months)

Eligibility
Key inclusion criteria
* Patients should complete the 24 month core study
Minimum age
20 Years
Maximum age
58 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Patients with other chronic disease of the immune system, malignancies, acute pulmonary disease, cardiac failure, etc.
* Pregnant or nursing women

Other protocol-defined inclusion/exclusion criteria may apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
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
1/02/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2011
Sample size
Target
Accrual to date
Final
920
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Novartis Investigative Site - Chatswood
Recruitment hospital [2] 0 0
Novartis Investigative Site - Fitzroy
Recruitment hospital [3] 0 0
Austin Health, Department of Neurology - Heidelberg
Recruitment hospital [4] 0 0
Novartis Investigative Site - North Gosford
Recruitment hospital [5] 0 0
Novartis Investigative Site - Woodville
Recruitment postcode(s) [1] 0 0
- Chatswood
Recruitment postcode(s) [2] 0 0
3065 - Fitzroy
Recruitment postcode(s) [3] 0 0
- Heidelberg
Recruitment postcode(s) [4] 0 0
- North Gosford
Recruitment postcode(s) [5] 0 0
- Woodville
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Brugge
Country [2] 0 0
Belgium
State/province [2] 0 0
Bruxelles
Country [3] 0 0
Belgium
State/province [3] 0 0
Charleroi
Country [4] 0 0
Belgium
State/province [4] 0 0
Leuven
Country [5] 0 0
Belgium
State/province [5] 0 0
Overpelt
Country [6] 0 0
Belgium
State/province [6] 0 0
Sijsele - Damme
Country [7] 0 0
Belgium
State/province [7] 0 0
Sint-Truiden
Country [8] 0 0
Canada
State/province [8] 0 0
Halifax
Country [9] 0 0
Canada
State/province [9] 0 0
Kingston
Country [10] 0 0
Canada
State/province [10] 0 0
London
Country [11] 0 0
Canada
State/province [11] 0 0
Montreal
Country [12] 0 0
Canada
State/province [12] 0 0
Nepean
Country [13] 0 0
Canada
State/province [13] 0 0
Regina
Country [14] 0 0
Canada
State/province [14] 0 0
Toronto
Country [15] 0 0
Canada
State/province [15] 0 0
Vancouver
Country [16] 0 0
Czech Republic
State/province [16] 0 0
Brno
Country [17] 0 0
Czech Republic
State/province [17] 0 0
Olomouc
Country [18] 0 0
Czech Republic
State/province [18] 0 0
Ostrava-Poruba
Country [19] 0 0
Czech Republic
State/province [19] 0 0
Pardubice
Country [20] 0 0
Czech Republic
State/province [20] 0 0
Plzen - Lochotin
Country [21] 0 0
Czech Republic
State/province [21] 0 0
Prague 5
Country [22] 0 0
Czech Republic
State/province [22] 0 0
Praha 2
Country [23] 0 0
Czech Republic
State/province [23] 0 0
Rychnov nad Kneznou
Country [24] 0 0
Czech Republic
State/province [24] 0 0
Teplice
Country [25] 0 0
Estonia
State/province [25] 0 0
Talinn
Country [26] 0 0
Finland
State/province [26] 0 0
Helsinki
Country [27] 0 0
Finland
State/province [27] 0 0
Tampere
Country [28] 0 0
Finland
State/province [28] 0 0
Turku
Country [29] 0 0
France
State/province [29] 0 0
Clermont Ferrand Cedex
Country [30] 0 0
France
State/province [30] 0 0
Dijon
Country [31] 0 0
France
State/province [31] 0 0
Lille Cedex
Country [32] 0 0
France
State/province [32] 0 0
Marseille cedex 05
Country [33] 0 0
France
State/province [33] 0 0
Montpellier cedex 5
Country [34] 0 0
France
State/province [34] 0 0
Nantes
Country [35] 0 0
France
State/province [35] 0 0
Paris Cedex 13
Country [36] 0 0
France
State/province [36] 0 0
Rennes
Country [37] 0 0
France
State/province [37] 0 0
Strasbourg
Country [38] 0 0
Germany
State/province [38] 0 0
Berlin
Country [39] 0 0
Germany
State/province [39] 0 0
Duesseldorf
Country [40] 0 0
Germany
State/province [40] 0 0
Gießen
Country [41] 0 0
Germany
State/province [41] 0 0
Hamburg
Country [42] 0 0
Germany
State/province [42] 0 0
Leipzig
Country [43] 0 0
Germany
State/province [43] 0 0
Magdeburg
Country [44] 0 0
Germany
State/province [44] 0 0
Muenchen
Country [45] 0 0
Germany
State/province [45] 0 0
Muenster
Country [46] 0 0
Germany
State/province [46] 0 0
Regensburg
Country [47] 0 0
Germany
State/province [47] 0 0
Stuttgart
Country [48] 0 0
Germany
State/province [48] 0 0
Tübingen
Country [49] 0 0
Greece
State/province [49] 0 0
Athens
Country [50] 0 0
Hungary
State/province [50] 0 0
Budapest
Country [51] 0 0
Hungary
State/province [51] 0 0
Miskolc
Country [52] 0 0
Hungary
State/province [52] 0 0
Szekesfehervar
Country [53] 0 0
Ireland
State/province [53] 0 0
Dublin 4
Country [54] 0 0
Israel
State/province [54] 0 0
Ashkelon
Country [55] 0 0
Israel
State/province [55] 0 0
Haifa
Country [56] 0 0
Israel
State/province [56] 0 0
Ramat Gan
Country [57] 0 0
Israel
State/province [57] 0 0
Safed
Country [58] 0 0
Netherlands
State/province [58] 0 0
Amsterdam
Country [59] 0 0
Netherlands
State/province [59] 0 0
Nieuwegein
Country [60] 0 0
Netherlands
State/province [60] 0 0
Nijmegen
Country [61] 0 0
Netherlands
State/province [61] 0 0
Rotterdam
Country [62] 0 0
Netherlands
State/province [62] 0 0
Sittard
Country [63] 0 0
Netherlands
State/province [63] 0 0
Tilburg
Country [64] 0 0
Poland
State/province [64] 0 0
Bialystok
Country [65] 0 0
Poland
State/province [65] 0 0
Gdansk
Country [66] 0 0
Poland
State/province [66] 0 0
Katowice
Country [67] 0 0
Poland
State/province [67] 0 0
Lodz
Country [68] 0 0
Poland
State/province [68] 0 0
Poznan
Country [69] 0 0
Poland
State/province [69] 0 0
Warsaw
Country [70] 0 0
Poland
State/province [70] 0 0
Warszawa
Country [71] 0 0
Romania
State/province [71] 0 0
Bucharest
Country [72] 0 0
Romania
State/province [72] 0 0
Craiova
Country [73] 0 0
Romania
State/province [73] 0 0
Lasi
Country [74] 0 0
Romania
State/province [74] 0 0
Tg. Mures
Country [75] 0 0
Russian Federation
State/province [75] 0 0
Kazan
Country [76] 0 0
Russian Federation
State/province [76] 0 0
Moscow
Country [77] 0 0
Russian Federation
State/province [77] 0 0
St. Petersburg
Country [78] 0 0
Slovakia
State/province [78] 0 0
Bratislava
Country [79] 0 0
Slovakia
State/province [79] 0 0
Martin
Country [80] 0 0
Slovakia
State/province [80] 0 0
Zilina
Country [81] 0 0
South Africa
State/province [81] 0 0
Cape Town
Country [82] 0 0
South Africa
State/province [82] 0 0
Rosebank
Country [83] 0 0
South Africa
State/province [83] 0 0
Umhlanga
Country [84] 0 0
Sweden
State/province [84] 0 0
Göteborg
Country [85] 0 0
Sweden
State/province [85] 0 0
Stockholm
Country [86] 0 0
Switzerland
State/province [86] 0 0
Lausanne
Country [87] 0 0
Switzerland
State/province [87] 0 0
Zuerich
Country [88] 0 0
Turkey
State/province [88] 0 0
Ankara
Country [89] 0 0
Turkey
State/province [89] 0 0
Bursa
Country [90] 0 0
Turkey
State/province [90] 0 0
Cerrahpasa/Istanbul
Country [91] 0 0
Turkey
State/province [91] 0 0
Gaziantep
Country [92] 0 0
Turkey
State/province [92] 0 0
Istanbul
Country [93] 0 0
Turkey
State/province [93] 0 0
Izmir
Country [94] 0 0
Turkey
State/province [94] 0 0
Mersin
Country [95] 0 0
Turkey
State/province [95] 0 0
Yenisehir/Izmir
Country [96] 0 0
United Kingdom
State/province [96] 0 0
Bristol
Country [97] 0 0
United Kingdom
State/province [97] 0 0
London
Country [98] 0 0
United Kingdom
State/province [98] 0 0
Newcastle Upon Tyne
Country [99] 0 0
United Kingdom
State/province [99] 0 0
Nottingham
Country [100] 0 0
United Kingdom
State/province [100] 0 0
Sheffield

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

Ethics approval
Ethics application status

Summary
Brief summary
This extension study of was designed to evaluate the long-term safety, tolerability, and efficacy of fingolimod (FTY720) in patients with multiple sclerosis. The Extension study was an extension to the 24-month Core study (CFTY720D2301/NCT00289978).
Trial website
https://clinicaltrials.gov/study/NCT00662649
Trial related presentations / publications
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/NCT00662649