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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00355134




Registration number
NCT00355134
Ethics application status
Date submitted
19/07/2006
Date registered
21/07/2006
Date last updated
7/08/2012

Titles & IDs
Public title
Efficacy and Safety of Fingolimod (FTY720) in Patients With Relapsing-remitting Multiple Sclerosis
Scientific title
24-month Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing the Efficacy and Safety of 0.5 mg and 1.25 mg Fingolimod (FTY720) Administered Orally Once Daily Versus Placebo in Patients With Relapsing-remitting Multiple Sclerosis With Optional Extension Phase
Secondary ID [1] 0 0
CFTY720D2309
Universal Trial Number (UTN)
Trial acronym
FREEDOMS II
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
Treatment: Drugs - Placebo

Experimental: Fingolimod 1.25 mg - Participants received 1.25 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 1.25 mg fingolimod orally once a day.

Note: Upon implementation of a protocol amendment all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.

Experimental: Fingolimod 0.5 mg - Participants received 0.5 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 0.5 mg fingolimod orally once a day.

Experimental: Placebo - Participants received placebo capsules orally once a day for up to 24 months during the core phase. In the Extension phase participants received either 1.25 or 0.5 mg fingolimod orally once a day.

Note: Upon implementation of a protocol amendment all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking placebo were switched to 0.5 mg fingolimod orally once a day.


Treatment: Drugs: Fingolimod
Fingolimod capsules for oral administration

Treatment: Drugs: Placebo
Matching placebo capsules for oral administration.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Aggregate Annualized Relapse Rate (ARR) Estimate up to Month 24
Timepoint [1] 0 0
24 months
Secondary outcome [1] 0 0
Aggregate Annualized Relapse Rate (ARR) Estimate up to End of Study
Timepoint [1] 0 0
From Baseline until end of study (up to approximately 54 months).
Secondary outcome [2] 0 0
Percent Change From Baseline in Brain Volume
Timepoint [2] 0 0
Baseline, Month 24 and end of study (up to approximately 54 months)
Secondary outcome [3] 0 0
Number of New or Newly Enlarged T2 Lesions
Timepoint [3] 0 0
From Baseline until Month 48
Secondary outcome [4] 0 0
Number of Gadolinium-enhanced T1 Lesions
Timepoint [4] 0 0
Month 24 and end of study (up to approximately 54 months)
Secondary outcome [5] 0 0
Change From Baseline in Lesion Volume at Month 24 (Core Phase)
Timepoint [5] 0 0
Baseline and Month 24
Secondary outcome [6] 0 0
Percentage of Participants Free of 3-month Confirmed Disability Progression at Month 24 and End of Study
Timepoint [6] 0 0
24 months and end of study (up to approximately 54 months)
Secondary outcome [7] 0 0
Percentage of Participants Free of 6-month Confirmed Disability Progression at Month 24 and End of Study
Timepoint [7] 0 0
24 months and end of study (up to approximately 54 months)
Secondary outcome [8] 0 0
Percentage of Participants Relapse-free up to Month 24
Timepoint [8] 0 0
24 months
Secondary outcome [9] 0 0
Percentage of Participants Relapse-free up to End of Study
Timepoint [9] 0 0
From Baseline until the end of study (up to approximately 54 months)
Secondary outcome [10] 0 0
Change From Baseline in Multiple Sclerosis Functional Composite (MSFC) Z-score
Timepoint [10] 0 0
Baseline, Month 24 and end of study (up to approximately 54 months)

Eligibility
Key inclusion criteria
* Male and female patients between ages 18-55 with a diagnosis of multiple sclerosis
* Patients with a relapsing-remitting disease course
* Patients with expanded disability status scale (EDSS) score of 0-5.5
Minimum age
18 Years
Maximum age
55 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

For inclusion in the extension phase patients should complete the 24 month core study with or without 24 months on study drug. If a patient discontinued study drug during the core study due to an adverse event, serious adverse event, laboratory abnormality etc. they would be excluded from the Extension Phase.

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 assessing the outcomes
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
1/06/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2011
Sample size
Target
Accrual to date
Final
1083
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Novartis Investigative Site - North Gosford
Recruitment postcode(s) [1] 0 0
- North Gosford
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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Arizona
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California
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Colorado
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Connecticut
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District of Columbia
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Florida
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Georgia
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Illinois
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Indiana
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Iowa
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Kansas
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Kentucky
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Maryland
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Massachusetts
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Michigan
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Missouri
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Nevada
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New Hampshire
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New Jersey
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New Mexico
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New York
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North Carolina
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Ohio
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Oklahoma
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Oregon
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Pennsylvania
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South Carolina
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Tennessee
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Texas
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Vermont
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Virginia
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Washington
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West Virginia
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Wisconsin
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Austria
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Vienna
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Canada
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Ontario
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Canada
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Quebec
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Bialystok
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Warsaw
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Warszawa
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Romania
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Bucharest
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Targu Mures
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Istanbul
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Izmir
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Yenisehir/Izmir
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United Kingdom
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Bristol

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00355134