Expired Study
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Bridgewater, New Jersey 08807


Purpose:

The primary objective was to determine the effect of teriflunomide on the frequency of relapses in patients with relapsing multiple sclerosis (MS). Secondary objectives were: - to evaluate the effect of teriflunomide on the accumulation of disability as measured by Expanded Disability Status Scale [EDSS], the burden of disease as measured by Magnetic Resonance Imaging [MRI] and patient-reported fatigue; - to evaluate the safety and tolerability of teriflunomide.


Study summary:

The study period per participant was approximatively 128 weeks broken down as follows: - Screening period up to 4 weeks, - 108-week double-blind treatment period (approximatively 2 years)*, - 16-week post-treatment elimination follow-up period. '*' Participants successfully completing the week 108 visit were offered the opportunity to enter the optional long-term extension study LTS6050 - NCT00803049.


Criteria:

Inclusion Criteria: - Multiple sclerosis [MS] subject who was ambulatory (EDSS of ≤ 5.5) - Exhibiting a relapsing clinical course, with or without progression (relapsing remitting, secondary progressive or progressive relapsing); - Meeting McDonald's criteria for MS diagnosis; - Experienced at least 1 relapse over the 1 year preceding the trial or at least 2 relapses over the 2 years preceding the trial; - No relapse onset in the preceding 60 days prior to randomization; - Clinically stable during the 30 days prior to randomization, without adrenocorticotrophic hormone [ACTH] or systemic steroid treatment. Exclusion Criteria: - Clinically relevant cardiovascular, hepatic, neurological, endocrine or other major systemic disease; - Significantly impaired bone marrow function; - Pregnant or nursing woman; - Alcohol or drug abuse; - Use of cladribine, mitoxantrone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate or mycophenolate before enrollment; - Any known condition or circumstance that would prevent in the investigator's opinion compliance or completion of the study;


NCT ID:

NCT00134563


Primary Contact:

Principal Investigator
Paul O'Connor, MD
St. Michael's Hospital Toronto (Canada)


Backup Contact:

N/A


Location Contact:

Bridgewater, New Jersey 08807
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 17, 2017

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