An Extension Study of the Efficacy and Safety of Fingolimod (FTY720) in Patients With Relapsing Multiple Sclerosis

This study has been completed.
Sponsor:
Collaborator:
Mitsubishi Tanabe Pharma Corporation
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00670449
First received: April 28, 2008
Last updated: June 26, 2013
Last verified: June 2013
Results First Received: March 8, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Multiple Sclerosis
Intervention: Drug: Fingolimod

  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 0.5 mg Patients who received fingolimod 0.5 orally once daily in the core study continued on the same dose in this extension study.
Fingolimod 1.25 mg Patients who received fingolimod 1.25 mg orally once daily in the core study continued on the same dose in this extension study.
Placebo-fingolimod 0.5 mg Patients who were randomized to placebo in the core study were re-randomized to either fingolimod 0.5 or 1.25 mg (1:1) orally once daily in this extension study.
Placebo-fingolimod 1.25 mg Patients who were randomized to placebo in the core study were re-randomized to either fingolimod 0.5 or 1.25 mg (1:1) orally once daily in this extension study.

Participant Flow:   Overall Study
    Fingolimod 0.5 mg     Fingolimod 1.25 mg     Placebo-fingolimod 0.5 mg     Placebo-fingolimod 1.25 mg  
STARTED     47     46     27     23  
Switched to 0.5mg (Open Label)     45     41 [1]   23     17 [1]
COMPLETED     38     36     18     15  
NOT COMPLETED     9     10     9     8  
Adverse Event                 6                 2                 8                 5  
Protocol Deviation                 1                 2                 0                 1  
Administrative Problems                 0                 2                 0                 1  
Subject Withdrew Consent                 0                 2                 0                 1  
Unsatisfactory Therapeutic Effect                 2                 0                 1                 0  
Abnormal Laboratory Value(s)                 0                 2                 0                 0  
[1] Following protocol amendment, study became open-label with all patients receiving FTY720 0.5 mg/day



  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 0.5 mg Patients who received fingolimod 0.5 orally once daily in the core study continued on the same dose in this extension study.
Fingolimod 1.25 mg Patients who received fingolimod 1.25 mg orally once daily in the core study continued on the same dose in this extension study.
Placebo-fingolimod 0.5 mg Patients who were randomized to placebo in the core study were re-randomized to either fingolimod 0.5 or 1.25 mg (1:1) orally once daily in this extension study.
Placebo-fingolimod 1.25 mg Patients who were randomized to placebo in the core study were re-randomized to either fingolimod 0.5 or 1.25 mg (1:1) orally once daily in this extension study.
Total Total of all reporting groups

Baseline Measures
    Fingolimod 0.5 mg     Fingolimod 1.25 mg     Placebo-fingolimod 0.5 mg     Placebo-fingolimod 1.25 mg     Total  
Number of Participants  
[units: participants]
  47     46     27     23     143  
Age  
[units: years]
Mean ± Standard Deviation
  34.9  ± 8.95     35.7  ± 8.81     34.2  ± 9.08     35.5  ± 8.44     35.1  ± 8.78  
Gender  
[units: participants]
         
Female     33     31     19     14     97  
Male     14     15     8     9     46  



  Outcome Measures
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1.  Primary:   Percentage of Patients Free of Gd-enhanced T1 Weighted Magnetic Resonance Imaging (MRI) Lesions   [ Time Frame: Months 6, 9, 12, 18, 24, 36, and 48 ]

2.  Secondary:   Percentage of Patients Free of New or Newly Enlarged T2 Weighted MRI Lesions   [ Time Frame: Months 0-3, 3-6, 6-9, 9-12, 12-18, 18-24, 24-36,36-48, and 48 to the end of the study (up to 4 years) ]

3.  Secondary:   Aggregate Annualized Relapse Rate (ARR) Based on Confirmed Relapses   [ Time Frame: Months 0-6, 6-12, 12-24, 24-36, 36-48, and 48 to the end of the study (up to 4 years) ]

4.  Secondary:   Percentage of Patients Relapse-free at the End of the Study   [ Time Frame: Baseline to the end of the study (up to 4 years) ]

5.  Secondary:   Percentage of Patients Free From 3-month and 6-month Confirmed Disability Progression at Their Last Expanded Disability Status Scale (EDSS) Assessment   [ Time Frame: Baseline to the end of the study (up to 4 years) ]

6.  Secondary:   Change From Core Study Baseline in the Expanded Disability Status Scale (EDSS) Score   [ Time Frame: Baseline to Months 12, 24, 36, 48, and end of study (up to 4 years) ]


  Serious Adverse Events


  Other Adverse Events


  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: NCT00670449     History of Changes
Other Study ID Numbers: CFTY720D1201E1
Study First Received: April 28, 2008
Results First Received: March 8, 2013
Last Updated: June 26, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare