Status:
COMPLETED
An Extension Study of the Efficacy and Safety of Fingolimod (FTY720) in Patients With Relapsing Multiple Sclerosis
Lead Sponsor:
Novartis
Collaborating Sponsors:
Tanabe Pharma Corporation
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief Summary
This study was an extension study of NCT00537082. This study was designed to evaluate the efficacy and safety of long-term administration of 0.5 mg or 1.25 mg of fingolimod (FTY720) to relapsing multi...
Detailed Description
A decision was made to switch all patients on fingolimod 1.25 mg/day to fingolimod 0.5 mg/day in an amendment to the study protocol. The study became open-label with all patients receiving fingolimod ...
Eligibility Criteria
Inclusion
- Patients who completed 6 months of treatment with the study drug and the Month 6 visit in the core study NCT00537082.
- Females of childbearing potential who have a negative pregnancy test in the core study NCT00537082.
Exclusion
- Patients who permanently discontinued study drug treatment prior to the Month 6 visit in the core study NCT00537082.
- Other protocol-defined inclusion/exclusion criteria applied to the study.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
143 Patients enrolled
Trial Details
Trial ID
NCT00670449
Start Date
April 1 2008
End Date
April 1 2012
Last Update
September 4 2013
Active Locations (20)
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1
Novartis Investigative Site
Chiba, Japan, 276-8524
2
Novartis Investigative Site
Ehime, Japan, 791-0295
3
Novartis Investigative Site
Fukuoka, Japan, 807-8555
4
Novartis Investigative Site
Gunma, Japan, 371-8511