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Efficacy and Safety of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis (FREEDOMS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00289978
First received: February 9, 2006
Last updated: April 9, 2012
Last verified: April 2012
Results First Received: January 4, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Relapsing-remitting Multiple Sclerosis
Interventions: Drug: Fingolimod 1.25 mg
Drug: Fingolimod 0.5 mg
Drug: Placebo

  Participant Flow


  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Fingolimod 1.25 mg Patients self-administered fingolimod 1.25 mg capsules orally once daily.
Fingolimod 0.5 mg Patients self-administered fingolimod 0.5 mg capsules orally once daily.
Placebo Patients self-administered a fingolimod placebo capsule orally once daily.
Total Total of all reporting groups

Baseline Measures
    Fingolimod 1.25 mg     Fingolimod 0.5 mg     Placebo     Total  
Number of Participants  
[units: participants]
  429     425     418     1272  
Age  
[units: years]
Mean ± Standard Deviation
  37.4  ± 8.91     36.6  ± 8.77     37.2  ± 8.60     37.1  ± 8.76  
Age, Customized  
[units: participants]
       
<18 years     1     0     0     1  
18 -30     107     120     97     324  
31-40     147     162     165     474  
41-55     174     143     156     473  
Gender  
[units: participants]
       
Female     295     296     298     889  
Male     134     129     120     383  
Duration of multiple sclerosis since first symptoms  
[units: Years]
Mean ± Standard Deviation
  8.4  ± 6.86     8.0  ± 6.60     8.1  ± 6.35     8.2  ± 6.60  
Number of relapses in last 2 years  
[units: relapses]
Mean ± Standard Deviation
  1.5  ± 0.81     1.5  ± 0.76     1.4  ± 0.73     1.5  ± 0.77  
Expanded Disability Status Scale (EDSS) [1]
[units: Units on a scale]
Mean ± Standard Deviation
  2.41  ± 1.36     2.30  ± 1.29     2.49  ± 1.29     2.40  ± 1.32  
[1] The EDSS is a scale for assessing disability in 8 functional systems (visual, brain stem, pyramidal, cerebellar, sensory, bowel & bladder, cerebral, other functions). Based on scores in these 8 functional systems, an overall score ranging from 0 (normal) to 10 (death due to MS) is assigned. Patients with EDSS scores of 0.0 to 4.5 are fully ambulatory; patients with EDSS scores of 5.0 to 9.5 have impaired ambulation. EDSS was assessed by an evaluating physician at each site.



  Outcome Measures
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1.  Primary:   Estimated Annualized Aggregate Relapse Rate (ARR)   [ Time Frame: Baseline to end of study (Month 24) ]

2.  Secondary:   Percentage of Patients Free of Disability Progression at Month 24 Assessed With the Expanded Disability Status Scale (EDSS)   [ Time Frame: Baseline to end of study (Month 24) ]

3.  Secondary:   Number of New or Newly Enlarged T2 Lesions at Month 24 in Comparison With Baseline   [ Time Frame: Baseline to end of study (Month 24) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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