This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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;   Intervention Model: Parallel Assignment;   Masking: Double Blind (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) ]

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
  Hide Other Adverse Events

Time Frame 24 Months
Additional Description Adverse events are reported based on the safety population. The safety population consists of all patients who received at least 1 dose of study drug.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

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.

Other Adverse Events
    Fingolimod 1.25 mg   Fingolimod 0.5 mg   Placebo
Total, Other (not including serious) Adverse Events       
# participants affected / at risk   346/429 (80.65%)   355/425 (83.53%)   323/418 (77.27%) 
Ear and labyrinth disorders       
Vertigo † 1       
# participants affected / at risk   18/429 (4.20%)   18/425 (4.24%)   21/418 (5.02%) 
Gastrointestinal disorders       
Diarrhoea † 1       
# participants affected / at risk   40/429 (9.32%)   50/425 (11.76%)   30/418 (7.18%) 
Nausea † 1       
# participants affected / at risk   38/429 (8.86%)   38/425 (8.94%)   36/418 (8.61%) 
General disorders       
Fatigue † 1       
# participants affected / at risk   46/429 (10.72%)   48/425 (11.29%)   45/418 (10.77%) 
Infections and infestations       
Bronchitis † 1       
# participants affected / at risk   39/429 (9.09%)   34/425 (8.00%)   15/418 (3.59%) 
Influenza † 1       
# participants affected / at risk   40/429 (9.32%)   55/425 (12.94%)   41/418 (9.81%) 
Nasopharyngitis † 1       
# participants affected / at risk   112/429 (26.11%)   115/425 (27.06%)   115/418 (27.51%) 
Pharyngitis † 1       
# participants affected / at risk   25/429 (5.83%)   26/425 (6.12%)   23/418 (5.50%) 
Rhinitis † 1       
# participants affected / at risk   18/429 (4.20%)   25/425 (5.88%)   25/418 (5.98%) 
Sinusitis † 1       
# participants affected / at risk   27/429 (6.29%)   27/425 (6.35%)   19/418 (4.55%) 
Upper respiratory tract infection † 1       
# participants affected / at risk   62/429 (14.45%)   73/425 (17.18%)   72/418 (17.22%) 
Urinary tract infection † 1       
# participants affected / at risk   21/429 (4.90%)   34/425 (8.00%)   47/418 (11.24%) 
Investigations       
Alanine aminotransferase increased † 1       
# participants affected / at risk   49/429 (11.42%)   42/425 (9.88%)   16/418 (3.83%) 
Gamma-glutamyltransferase increased † 1       
# participants affected / at risk   31/429 (7.23%)   22/425 (5.18%)   4/418 (0.96%) 
Weight increased † 1       
# participants affected / at risk   14/429 (3.26%)   14/425 (3.29%)   22/418 (5.26%) 
Metabolism and nutrition disorders       
Hypercholesterolaemia † 1       
# participants affected / at risk   26/429 (6.06%)   24/425 (5.65%)   26/418 (6.22%) 
Musculoskeletal and connective tissue disorders       
Arthralgia † 1       
# participants affected / at risk   26/429 (6.06%)   30/425 (7.06%)   33/418 (7.89%) 
Back pain † 1       
# participants affected / at risk   45/429 (10.49%)   49/425 (11.53%)   28/418 (6.70%) 
Pain in extremity † 1       
# participants affected / at risk   24/429 (5.59%)   28/425 (6.59%)   27/418 (6.46%) 
Nervous system disorders       
Dizziness † 1       
# participants affected / at risk   31/429 (7.23%)   31/425 (7.29%)   23/418 (5.50%) 
Headache † 1       
# participants affected / at risk   113/429 (26.34%)   107/425 (25.18%)   96/418 (22.97%) 
Paraesthesia † 1       
# participants affected / at risk   17/429 (3.96%)   23/425 (5.41%)   18/418 (4.31%) 
Psychiatric disorders       
Depression † 1       
# participants affected / at risk   25/429 (5.83%)   33/425 (7.76%)   28/418 (6.70%) 
Insomnia † 1       
# participants affected / at risk   16/429 (3.73%)   21/425 (4.94%)   25/418 (5.98%) 
Respiratory, thoracic and mediastinal disorders       
Cough † 1       
# participants affected / at risk   37/429 (8.62%)   43/425 (10.12%)   34/418 (8.13%) 
Dyspnoea † 1       
# participants affected / at risk   25/429 (5.83%)   30/425 (7.06%)   19/418 (4.55%) 
Oropharyngeal pain † 1       
# participants affected / at risk   17/429 (3.96%)   29/425 (6.82%)   29/418 (6.94%) 
Vascular disorders       
Hypertension † 1       
# participants affected / at risk   27/429 (6.29%)   26/425 (6.12%)   15/418 (3.59%) 
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA 12.0



  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