We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00289978
First Posted: February 10, 2006
Last Update Posted: April 11, 2012
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.
Information provided by (Responsible Party):
Novartis
Results First Submitted: January 4, 2011  
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
  Hide 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
  Hide 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
  Show All Outcome Measures

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

Measure Type Primary
Measure Title Estimated Annualized Aggregate Relapse Rate (ARR)
Measure Description The ARR is defined as the number of confirmed relapses in a year. A relapse is defined as the appearance of a new or worsening of a previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding relapse. The abnormality must be present for at least 24 hours and occur in the absence of fever or infection. The annualized ARR for each treatment group was the mean of the annualized ARRs for all patients in the group calculated as the total number of confirmed relapses divided by the total number of days on study, multiplied by 365.25.
Time Frame Baseline to end of study (Month 24)  

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.
This analysis was conducted using the Intent-to-treat (ITT) population which includes all patients who were randomized and received at least one dose of study drug.

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 
Participants Analyzed 
[Units: Participants]
 429   425   418 
Estimated Annualized Aggregate Relapse Rate (ARR) 
[Units: Relapses per year]
Number (95% Confidence Interval)
 0.16 
 (0.13 to 0.19) 
 0.18 
 (0.15 to 0.22) 
 0.40 
 (0.34 to 0.47) 

No statistical analysis provided for Estimated Annualized Aggregate Relapse Rate (ARR)



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
  Hide 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
No text entered.


  More Information