Efficacy and Safety of FTY720 in Patients With Relapsing Multiple Sclerosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00333138
First received: June 1, 2006
Last updated: December 24, 2013
Last verified: December 2013

June 1, 2006
December 24, 2013
May 2003
April 2011   (final data collection date for primary outcome measure)
  • Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 6 (Core) [ Time Frame: Month 6 (Core) ] [ Designated as safety issue: No ]
    Total number of post-baseline Gd-enhanced lesions is calculated as a sum of all Gd-enhanced lesions seen on post-baseline scans per visit. Real (not per slice) lesions are counted in this analysis.
  • Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 12 [ Time Frame: Month 12 (extension) ] [ Designated as safety issue: No ]
    Total number of post-baseline Gd-enhanced lesions is calculated as a sum of all Gd-enhanced lesions seen on post-baseline scans per visit. Real (not per slice) lesions are counted in this analysis.
  • Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 60 [ Time Frame: Month 60 (extension) ] [ Designated as safety issue: No ]
    Total number of post-baseline Gd-enhanced lesions is calculated as a sum of all Gd-enhanced lesions seen on post-baseline scans per visit. Real (not per slice) lesions are counted in this analysis.
  • Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at End of Study [ Time Frame: Last observation (Up to 80 months in average) ] [ Designated as safety issue: No ]
    Total number of post-baseline Gd-enhanced lesions is calculated as a sum of all Gd-enhanced lesions seen on post-baseline scans per visit. Real (not per slice) lesions are counted in this analysis. The last observation was the last observation available for each patient which ranged from 1 to 2801 days
  • Monthly MRI lesion parameters
  • Safety and tolerability of 2 doses of FTY720 at Month 6
Complete list of historical versions of study NCT00333138 on ClinicalTrials.gov Archive Site
  • Percentage of Participants Free of T1-weighted Lesions [ Time Frame: Baseline, Months 6 (core), 12, 60 and Last Observation (up to 80 months in average) ] [ Designated as safety issue: No ]
    A patient was defined as free of lesions if s/he had zero lesions. The last observation was the last observation available for each patient which ranged from 1 to 2801 days
  • Percentage of Patients Free of Gd-enhanced T1-weighted and New T2- Weighted Lesions by Visit [ Time Frame: Month 6 and 12, 60, last observation (up to 80 months in average) ] [ Designated as safety issue: No ]
    A patient was defined as free of lesions if s/he had zero lesions. The sum of all new T2-weighted lesions at Month 1 to last observation was zero (the sum is missing if one of the assessments was missing). New T2 lesions at a specific visit were assessed relative to the previous visit scan. Exception: new T2 lesions at Month 24 were assessed relative to Month 12. The last observation was the last observation available for each patient which ranged from 1 to 2801 days
  • Mean Number of New T2-weighted Lesions [ Time Frame: (Core) Month 6 and (Extension) 12, 60, last observation (up to 80 months in average) ] [ Designated as safety issue: No ]
    New T2 lesions at a specific visit were assessed relative to the previous visit scan. The total number of lesions (Month 1 to end of study) is calculated as the sum of the number of lesions at Months 1 to 6, Month 12, Month 60 and last observation. The last observation was the last observation available for each patient which ranged from 1 to 2801 days
  • Volume of T2-weighted Lesions [ Time Frame: (Core) Month 6 and (Extension) 12, 60, last observation (up to 80 months in average) ] [ Designated as safety issue: No ]
    Volume of total T2-weighted lesions by visit were summarized. The last observation was the last observation available for each patient which ranged from 1 to 2801 days
  • Change From Baseline in Volume of Total T2-weighted Lesions [ Time Frame: Baseline to month 6, 12, 60 and Last observation (up to 80 months in average) ] [ Designated as safety issue: No ]
    Change in volume of total T2-weighted lesions by visit were summarized. Negative values indicate improvement (reduction in lesion volume) and positive values worsening (increase in lesion volume). The last observation was the last observation available for each patient which ranged from 1 to 2801 days.
  • Time to Event Analysis: Kaplan Meier Estimates of Percentage of Relapse-free Patients [ Time Frame: Month 6,12,60 and Last observation (up to 80 months in average) ] [ Designated as safety issue: No ]
    The Expanded Disability Status Scale (EDSS) is a scale for assessing disability in 8 functional systems (visual, brain stem, pyramidal, cerebellar, sensory, bowel & bladder, cerebral, other functions). An overall score ranging from 0 (normal) to 10 (death due to MS) is calculated. Disability progression was determined by the EDSS score based on the following criteria: One point increase from baseline in patients with baseline EDSS score from 0 to 5.0; or half a point increase in patients with baseline EDSS score of 5.5 or above. Percent of patients free of disability progression was calculated using the Kaplan-Meier method. The last observation was the last observation available for each patient which ranged from 1 to 2801 days
  • Mean Trough Blood Concentrations of FTY720 [ Time Frame: Month 3 and 6 ] [ Designated as safety issue: No ]
    For each patient, the arithmetic mean of the two FTY720 trough blood levels from month 3 and 6 was calculated. This was taken as the patient's steady-state trough levels. Venous blood samples (3 mL) were collected before the dose in ethylenediaminetetraacetic acid (EDTA)-containing tubes at protocol-scheduled visits at months 3 and 6 in all patients.
  • Time to first relapse at Month 6
  • Proportion of relapse-free patients at Month 6
Not Provided
Not Provided
 
Efficacy and Safety of FTY720 in Patients With Relapsing Multiple Sclerosis
Double-blind, Randomized, Placebo-controlled, Parallel-group, Multicenter Study Evaluating the Safety, Tolerability and Effect on MRI Lesion Parameters of FTY720 vs Placebo in Patients With Relapsing Multiple Sclerosis Including 18 Month Extension Phase

This study evaluated the safety, tolerability and effect on MRI lesion parameters of FTY720 in patients with relapsing multiple sclerosis.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Multiple Sclerosis
  • Drug: FTY720
    FTY720 capsule was taken orally once a day
  • Drug: Placebo
    Placebo 1.25 mg capsule was given once daily
  • Experimental: Fingolimod (FTY720) 1.25 mg/day
    Core study: patients received fingolimod 1.25 mg, once daily for 6 months. Extension: In dose -blind period and open label, fingolimod 1.25 mg once daily for 9-18 months (6 months to 24 months). Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
    Intervention: Drug: FTY720
  • Placebo Comparator: Placebo/Fingolimod (FTY720)
    Core study: patients received placebo, once daily for 6 months. Extension: In dose-blind period patients were re-randomized into either fingolimod 1.25 mg or 5.0 mg once per day for 6-15 months. In open-label period patients received fingolimod 1.25 mg once per day for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
    Intervention: Drug: Placebo
  • Experimental: Fingolimod (FTY720) 5.0 mg/day
    Core study: patients received fingolimod 5.0 mg, once daily for 6 months. Extension: In dose-blind period fingolimod 5.0 mg once daily for 6-15 months. For open-label phase 15 to 24 months 1.25mg once daily. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
    Intervention: Drug: FTY720

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
281
April 2011
April 2011   (final data collection date for primary outcome measure)

Core Study

Inclusion Criteria:

  • Diagnosis of relapsing multiple Sclerosis (MS)
  • Patients with at least two documented relapses in the previous 2 years or one documented relapse in the last year
  • Patients with an Expanded Disability Status Scale (EDSS) score of 0-6

Extension Study

  • A positive Gd-enhanced MRI scan at screening (in case the first MRI scan obtained at screening was negative, a second scan could have been obtained 1 month later)
  • Neurologically stable with no evidence of relapse within 30 days prior to randomization,or during the Screening and Baseline periods.
  • Female patients either post-menopausal, surgically incapable of bearing children, or practicing an acceptable method of birth control. Females of childbearing potential with a negative pregnancy test at baseline prior to entry into the treatment period.

Exclusion Criteria:

Core Study

  • Patients with other chronic disease of the immune system, malignancies, pulmonary or heart disease, etc
  • Pregnant or nursing women

Extension Study

  • Patients who had permanently discontinued study drug prior to the Month 6 visit of the core study
  • Patients with diabetes mellitus (to reduce the risk of ME), and therefore ongoing patients with diabetes mellitus or who developed diabetes mellitus were discontinued from the study)

Other protocol-defined inclusion/exclusion criteria may apply

Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Denmark,   Finland,   France,   Germany,   Italy,   Poland,   Portugal,   Spain,   Switzerland,   United Kingdom
 
NCT00333138
CFTY720D2201, CFTY720D2201E1
Not Provided
Novartis
Novartis
Not Provided
Study Chair: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP