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
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
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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) ]

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
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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     355/425     323/418  
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



  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


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.  


Results Point of Contact:  
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862 778-8300


No publications provided by Novartis

Publications automatically indexed to this study:

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00289978     History of Changes
Other Study ID Numbers: CFTY720D2301
Study First Received: February 9, 2006
Results First Received: January 4, 2011
Last Updated: April 9, 2012
Health Authority: Sweden: Regional Ethical Review Board