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
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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.

Participant Flow:   Overall Study
    Fingolimod 1.25 mg     Fingolimod 0.5 mg     Placebo  
STARTED     429     425     418  
COMPLETED     332 [1]   369 [2]   332 [3]
NOT COMPLETED     97     56     86  
Withdrawal by Subject                 31                 17                 28  
Adverse Event                 22                 13                 18  
Lack of Efficacy                 13                 6                 25  
Abnormal laboratory value(s)                 20                 9                 1  
Lost to Follow-up                 3                 5                 7  
Protocol Violation                 5                 5                 4  
Abnormal test procedure result(s)                 2                 1                 1  
Death                 1                 0                 2  
[1] 296 completed on study drug, 35 completed off study drug.
[2] 345 completed on study drug, 24 completed off study drug.
[3] 303 completed on study drug, 29 completed off study drug.



  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.
No text entered.

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) ]
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Measure Type Secondary
Measure Title Percentage of Patients Free of Disability Progression at Month 24 Assessed With the Expanded Disability Status Scale (EDSS)
Measure Description EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) is calculated. Disability progression was determined by the following: 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. A 3-month confirmed disability progression required onset EDSS, 3-month confirming EDSS, and all EDSS in between to meet the disability progression criteria. Percent of free of disability progression was calculated using the Kaplan Meier method.
Time Frame Baseline to end of study (Month 24)  
Safety Issue No  

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.
Intent-to-treat population (ITT): All patients who were randomized and received at least one dose of study medication.

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.

Measured Values
    Fingolimod 1.25 mg     Fingolimod 0.5 mg     Placebo  
Number of Participants Analyzed  
[units: participants]
  429     425     418  
Percentage of Patients Free of Disability Progression at Month 24 Assessed With the Expanded Disability Status Scale (EDSS)  
[units: Percentage of participants]
Number ( 95% Confidence Interval )
  83.4  
  ( 79.7 to 87.1 )  
  82.3  
  ( 78.6 to 86.1 )  
  75.9  
  ( 71.7 to 80.2 )  

No statistical analysis provided for Percentage of Patients Free of Disability Progression at Month 24 Assessed With the Expanded Disability Status Scale (EDSS)



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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