Efficacy and Safety of Fingolimod (FTY720) in Patients With Relapsing-remitting Multiple Sclerosis (FREEDOMS II)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00355134
First received: July 19, 2006
Last updated: August 2, 2012
Last verified: August 2012
Results First Received: May 23, 2012  
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: Multiple Sclerosis
Interventions: Drug: Fingolimod
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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients were randomized to receive fingolimod 0.5 mg, 1.25 mg or placebo for up to 24 months. Upon entry into the Extension phase, patients treated with fingolimod 0.5 mg or 1.25 mg during the Core phase continued treatment at the same dose, those previously treated with placebo were re-randomized in to receive one of the two doses of fingolimod.

Reporting Groups
  Description
Fingolimod 1.25 mg Participants received 1.25 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 1.25 mg fingolimod orally. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.
Fingolimod 0.5 mg Participants received 0.5 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 0.5 mg fingolimod orally once a day.
Placebo (Core) Participants received placebo capsules orally once a day for up to 24 months during the core phase. Upon implementation of a protocol amendment, all patients taking placebo were switched to 0.5 mg fingolimod orally once a day.
Extension: Fingolimod 1.25 mg Participants who had received placebo in the Core phase and then received 1.25 mg fingolimod orally once a day in the Extension phase. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.
Extension: Fingolimod 0.5 mg Participants who had received placebo in the Core phase and then received 0.5 mg fingolimod orally once a day in the Extension phase.

Participant Flow for 2 periods

Period 1:   Core Phase
    Fingolimod 1.25 mg     Fingolimod 0.5 mg     Placebo (Core)     Extension: Fingolimod 1.25 mg     Extension: Fingolimod 0.5 mg  
STARTED     370     358     355     0     0  
COMPLETED     251     272     255     0     0  
NOT COMPLETED     119     86     100     0     0  
Withdrawal by Subject                 35                 24                 35                 0                 0  
Adverse Event                 28                 22                 16                 0                 0  
Lost to Follow-up                 17                 13                 21                 0                 0  
Abnormal laboratory value(s)                 19                 14                 2                 0                 0  
Unsatisfactory therapeutic effect                 10                 6                 17                 0                 0  
Administrative problems                 5                 3                 5                 0                 0  
Protocol Violation                 3                 2                 2                 0                 0  
Abnormal test procedure result(s)                 1                 2                 1                 0                 0  
Condition no longer requires study drug                 1                 0                 1                 0                 0  

Period 2:   Extension Phase
    Fingolimod 1.25 mg     Fingolimod 0.5 mg     Placebo (Core)     Extension: Fingolimod 1.25 mg     Extension: Fingolimod 0.5 mg  
STARTED     203     217     0     105     107  
COMPLETED     172     180     0     89     88  
NOT COMPLETED     31     37     0     16     19  
Withdrawal by Subject                 7                 11                 0                 7                 5  
Adverse Event                 13                 9                 0                 3                 5  
Lost to Follow-up                 2                 6                 0                 2                 4  
Abnormal laboratory value(s)                 4                 2                 0                 2                 2  
Administrative problems                 2                 4                 0                 1                 1  
Unsatisfactory therapeutic effect                 3                 4                 0                 0                 1  
Abnormal test procedure result(s)                 0                 1                 0                 0                 1  
Protocol Violation                 0                 0                 0                 1                 0  



  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.
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Reporting Groups
  Description
Fingolimod 1.25 mg Participants received 1.25 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 1.25 mg fingolimod orally. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.
Fingolimod 0.5 mg Participants received 0.5 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 0.5 mg fingolimod orally once a day.
Placebo (Core) Participants received placebo capsules orally once a day for up to 24 months during the core phase. Upon implementation of a protocol amendment, all patients taking placebo were switched to 0.5 mg fingolimod orally once a day.
Extension: Fingolimod 1.25 mg Participants who had received placebo in the Core phase and then received 1.25 mg fingolimod orally once a day in the Extension phase. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.
Extension: Fingolimod 0.5 mg Participants who had received placebo in the Core phase and then received 0.5 mg fingolimod orally once a day in the Extension phase.
Total Total of all reporting groups

Baseline Measures
    Fingolimod 1.25 mg     Fingolimod 0.5 mg     Placebo (Core)     Extension: Fingolimod 1.25 mg     Extension: Fingolimod 0.5 mg     Total  
Number of Participants  
[units: participants]
  370     358     355     105     107     1295  
Age [1]
[units: years]
Mean ± Standard Deviation
  40.9  ± 8.90     40.6  ± 8.39     40.1  ± 8.42     NA  ± NA [2]   NA  ± NA [2]   40.5  ± 8.58  
Age [3]
[units: years]
Mean ± Standard Deviation
  40.6  ± 8.71     40.8  ± 7.96     NA  ± NA [4]   39.8  ± 8.32     41.1  ± 8.11     40.6  ± 8.28  
Gender [1]
[units: participants]
           
Female     281     275     288     0     0     844  
Male     89     83     67     0     0     239  
Gender [3]
[units: participants]
           
Female     148     160     0     88     85     481  
Male     55     57     0     17     22     151  
[1] Demographic data for the Core phase participant population.
[2] Age demographic data presented for Core phase population only.
[3] Demographic data for the Extension phase population. The number of participants in each treatment group in the Extension phase was 203, 217, 0, 105 and 107; Total participants 632.
[4] Age demographic data presented for the Extension phase population only.



  Outcome Measures
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1.  Primary:   Aggregate Annualized Relapse Rate (ARR) Estimate up to Month 24   [ Time Frame: 24 months ]

2.  Secondary:   Aggregate Annualized Relapse Rate (ARR) Estimate up to End of Study   [ Time Frame: From Baseline until end of study (up to approximately 54 months). ]

3.  Secondary:   Percent Change From Baseline in Brain Volume   [ Time Frame: Baseline, Month 24 and end of study (up to approximately 54 months) ]

4.  Secondary:   Number of New or Newly Enlarged T2 Lesions   [ Time Frame: From Baseline until Month 48 ]

5.  Secondary:   Number of Gadolinium-enhanced T1 Lesions   [ Time Frame: Month 24 and end of study (up to approximately 54 months) ]

6.  Secondary:   Change From Baseline in Lesion Volume at Month 24 (Core Phase)   [ Time Frame: Baseline and Month 24 ]

7.  Secondary:   Percentage of Participants Free of 3-month Confirmed Disability Progression at Month 24 and End of Study   [ Time Frame: 24 months and end of study (up to approximately 54 months) ]

8.  Secondary:   Percentage of Participants Free of 6-month Confirmed Disability Progression at Month 24 and End of Study   [ Time Frame: 24 months and end of study (up to approximately 54 months) ]

9.  Secondary:   Percentage of Participants Relapse-free up to Month 24   [ Time Frame: 24 months ]

10.  Secondary:   Percentage of Participants Relapse-free up to End of Study   [ Time Frame: From Baseline until the end of study (up to approximately 54 months) ]

11.  Secondary:   Change From Baseline in Multiple Sclerosis Functional Composite (MSFC) Z-score   [ Time Frame: Baseline, Month 24 and end of study (up to approximately 54 months) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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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.


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: NCT00355134     History of Changes
Obsolete Identifiers: NCT00774670
Other Study ID Numbers: CFTY720D2309
Study First Received: July 19, 2006
Results First Received: May 23, 2012
Last Updated: August 2, 2012
Health Authority: United States: Food and Drug Administration