Long Term Safety and Efficacy Study of Teriflunomide 7 mg or 14 mg in Patients With Relapsing-Remitting Multiple Sclerosis



Status:Completed
Conditions:Neurology, Neurology, Multiple Sclerosis
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:18 - 55
Updated:4/21/2016
Start Date:October 2006
End Date:December 2015

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Long-term Extension of the Multinational, Double-blind, Placebo Controlled Study EFC6049 (HMR1726D/3001) to Document the Safety of Two Doses of Teriflunomide (7 and 14 mg) in Patients With Multiple Sclerosis With Relapses

The primary objective of this study is to document the long-term safety and tolerability of
teriflunomide in Multiple Sclerosis (MS) patients with relapse.

The secondary objective is to document the long-term efficacy on disability progression,
relapse rate and Magnetic Resonance Imaging (MRI) parameters.

Patients completing the EFC6049 (HMR1726D/3001) study are given the opportunity to continue
in the extension study;

- patients receiving teriflunomide 7 mg or 14 mg are blindly maintained on the same dose
of teriflunomide.

- patients receiving placebo are randomized to teriflunomide 7 mg or 14 mg.

The study period per patient is broken down as follows:

- Double-blind treatment: up to a maximum of 288 weeks or until teriflunomide is
commercially available in the country where patient lives,

- Post-washout follow-up: 4 weeks after last treatment intake. No post-washout follow up
if patient continues on teriflunomide treatment by obtaining it's commercial form after
end of the study.

The total duration of the extension is 292 weeks (about 6 years) from the first patient
enrolled or until teriflunomide is commercially available in the country where patient
lives.

Inclusion Criteria:

- Patient who has completed the previous double-blind placebo-controlled study EFC6049
and who does not meet criteria for treatment withdrawal.

- Willingness to participate in a long-term safety/efficacy trial.

Exclusion Criteria:

- Any known condition or circumstance that would prevent in the investigator's opinion,
compliance or completion of the study.

The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.
We found this trial at
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