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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00289978
Recruitment Status : Completed
First Posted : February 10, 2006
Results First Posted : March 16, 2011
Last Update Posted : April 11, 2012
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, 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

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
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Reporting Groups
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

  Outcome Measures

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

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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  More Information