Multiple Sclerosis Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Design Study to Evaluate the Efficacy and Safety of Teriflunomide in Reducing the Frequency of Relapses and Delaying the Accumulation of Physical Disability in Subjects With Multiple Sclerosis With Relapses
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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