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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
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Belgium
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Brugge
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Belgium
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Bruxelles
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Belgium
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Charleroi
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Leuven
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Overpelt
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Sijsele - Damme
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Halifax
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Kingston
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Dijon
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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