Status:
COMPLETED
Efficacy and Safety of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis
Lead Sponsor:
Novartis
Conditions:
Relapsing-remitting Multiple Sclerosis
Eligibility:
All Genders
18-55 years
Phase:
PHASE3
Brief Summary
This study assessed the efficacy, safety, and tolerability of 2 doses of oral fingolimod (1.25 mg/day and 0.5 mg/day) compared to placebo in patients with relapsing-remitting multiple sclerosis (RRMS)
Eligibility Criteria
Inclusion
- Male and female patients between ages 18-55 with a diagnosis of multiple sclerosis
- Patients with a relapsing-remitting disease course
- Patients with EDSS score of 0-5.5
Exclusion
- Patients with other chronic disease of the immune system, malignancies, acute pulmonary disease, cardiac failure, etc.
- Pregnant or nursing women
- Other protocol-defined inclusion/exclusion criteria applied to this study.
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
1272 Patients enrolled
Trial Details
Trial ID
NCT00289978
Start Date
January 1 2006
End Date
July 1 2009
Last Update
April 11 2012
Active Locations (115)
Enter a location and click search to find clinical trials sorted by distance.
1
The Queen Elizabeth Hospital
Woodville South, South Australia, Australia, 5011
2
North Gosford Private Hospital
Burrabil Avenue, Suite 17, Gosford, Australia, NSW 2250
3
Strategic Health Evaluators
Chatswood, Australia, 2067
4
St Vincent's Hospital Melbourne, Department of Clinical Neurosciences
Fitzroy, Australia, 3065 VIC