Overview

A Study to Evaluate the Safety of Long Term Treatment With Teriflunomide 14 mg Once Daily in Patients With a First Clinical Episode Suggestive of Multiple Sclerosis in a Long-term Extension Period

Status:
Unknown status

Trial end date:
2019-01-18

Target enrollment:

Participant gender:

Summary

National, multicenter study: The study consists of 3 periods: 1. A baseline visit to confirm that patient is still in CIS status. All patients will be clinically evaluated for CDMS and an MRI (less than 2 months) will be analyzed to exclude MS patients according to 2010 Mc Donald's criteria. 2. Treatment period with timed evaluations 3. Post-treatment period: 4 weeks, with 2 visits following study drug discontinuation and accelerated elimination procedure. All patients who discontinue the study drug and according to investgator's decision, will perform the accelerated elimination procedure and the post- accelerated elimination visits (at 2 and 4 weeks after the end of treatment (EOT).

Phase:

Phase 3

Details

Lead Sponsor:

Centre Hospitalier Universitaire de Nice

Treatments:

Teriflunomide