Status:
COMPLETED
Efficacy and Safety of FTY720 in Patients With Relapsing Multiple Sclerosis
Lead Sponsor:
Novartis
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief Summary
This study evaluated the safety, tolerability and effect on MRI lesion parameters of FTY720 in patients with relapsing multiple sclerosis.
Eligibility Criteria
Inclusion
- Core Study
- Diagnosis of relapsing multiple Sclerosis (MS)
- Patients with at least two documented relapses in the previous 2 years or one documented relapse in the last year
- Patients with an Expanded Disability Status Scale (EDSS) score of 0-6
- Extension Study
- A positive Gd-enhanced MRI scan at screening (in case the first MRI scan obtained at screening was negative, a second scan could have been obtained 1 month later)
- Neurologically stable with no evidence of relapse within 30 days prior to randomization,or during the Screening and Baseline periods.
- Female patients either post-menopausal, surgically incapable of bearing children, or practicing an acceptable method of birth control. Females of childbearing potential with a negative pregnancy test at baseline prior to entry into the treatment period.
Exclusion
- Core Study
- Patients with other chronic disease of the immune system, malignancies, pulmonary or heart disease, etc
- Pregnant or nursing women
- Extension Study
- Patients who had permanently discontinued study drug prior to the Month 6 visit of the core study
- Patients with diabetes mellitus (to reduce the risk of ME), and therefore ongoing patients with diabetes mellitus or who developed diabetes mellitus were discontinued from the study)
- Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
May 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
281 Patients enrolled
Trial Details
Trial ID
NCT00333138
Start Date
May 1 2003
End Date
April 1 2011
Last Update
September 15 2017
Active Locations (26)
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1
Novartis Investigational site
Montreal, Canada
2
Novartis Investigational site
Ottawa, Canada
3
Novartis Investigational site
Toronto, Canada
4
Novartis Investigational site
Vancouver, Canada