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Safety and Tolerability of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01497262
First received: December 5, 2011
Last updated: March 17, 2015
Last verified: March 2015
Results First Received: February 26, 2015  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   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
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Reporting Groups
  Description
Fingolimod 0.5 mg Open-label fingolimod 0.5 mg, taken orally once daily for 4 months

Participant Flow:   Overall Study
    Fingolimod 0.5 mg  
STARTED     162  
COMPLETED     151  
NOT COMPLETED     11  
Abnormal Lab Values                 4  
Abnormal Test Procedure Result                 1  
Physician Decision                 1  
Withdrawal by Subject                 2  
Adverse Event                 2  
Protocol Violation                 1  



  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.
The Enrolled Set (ENR) included all patients who signed the informed consent and enrolled in study

Reporting Groups
  Description
Fingolimod 0.5 mg Open-label fingolimod 0.5 mg, taken orally once daily for 4 months

Baseline Measures
    Fingolimod 0.5 mg  
Number of Participants  
[units: participants]
  162  
Age  
[units: Years]
Mean (Standard Deviation)
  37.3  (9.67)  
Age, Customized  
[units: Participants]
 
<18 years     0  
18-30 years     47  
31-40 years     60  
41-55 years     47  
56-65 years     8  
>65 years     0  
Gender  
[units: Participants]
 
Female     114  
Male     48  



  Outcome Measures
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1.  Primary:   Number of Participants With Adverse Events as a Measure of Safety and Tolerability   [ Time Frame: 28 weeks ]

2.  Secondary:   Number (%) of Patients With AE of Special Interest Including Bradyarrhythmia, BP Increase, Liver Transaminase Elevations, Infections , Macula Oedema.   [ Time Frame: 4 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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01497262     History of Changes
Other Study ID Numbers: CFTY720D2325
Study First Received: December 5, 2011
Results First Received: February 26, 2015
Last Updated: March 17, 2015
Health Authority: United States: Food and Drug Administration
Brazil: Ministry of Health
Argentina: Ministry of Health
Colombia: Institutional Review Board
Jordan: Ethical Committee
Malaysia: Ministry of Health
Mexico: Ministry of Health
Panama: Ministry of Health
Peru: Ministry of Health