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

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ClinicalTrials.gov Identifier: NCT00289978
Recruitment Status : Completed
First Posted : February 10, 2006
Results First Posted : March 16, 2011
Last Update Posted : April 11, 2012
Sponsor:
Information provided by (Responsible Party):
Novartis

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
No text entered.

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

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 
Overall Participants Analyzed 
[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

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

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) ]
  Show Outcome Measure 2

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) ]
  Show Outcome Measure 3


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats


  More Information