An Efficacy Study of Teriflunomide in Patients With Relapsing 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:August 2008
End Date:August 2015

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A Multi-center Double-blind Parallel-group Placebo-controlled Study of the Efficacy and Safety of Teriflunomide in Patients With Relapsing Multiple Sclerosis

The primary objective of the study is to assess the effect of two doses of Teriflunomide, in
comparison to placebo, on the frequency of multiple sclerosis (MS) relapses in patients with
relapsing MS.

Key secondary objective is to assess the effect of the two doses of teriflunomide, in
comparison to placebo, on disability progression.

Other secondary objectives are:

- To assess the effect of the two doses of teriflunomide in comparison to placebo on:

- Fatigue;

- Health-related quality of life, a measure of the impact of the patient's health on
his or her overall well being.

- To evaluate the safety and tolerability of teriflunomide.

The study consists in:

- A core treatment period: Teriflunomide 7 mg or Teriflunomide 14 mg or placebo is
administered in double-blind fashion until a fixed common end date which is
approximately 48 weeks after randomization of the last participant.

- An extension treatment period: the highest dose of teriflunomide is administered in
open-label fashion to participants who successfully complete the core treatment period
and wish to continue.

The overall treatment period is followed by a 4-week elimination follow-up period.

Inclusion Criteria:

- Relapsing multiple sclerosis,

- Two relapses in prior 2 years or one relapse in prior year.

Exclusion Criteria:

- Clinically relevant cardiovascular, hepatic, neurological, endocrine or other major
systemic disease,

- Significantly impaired bone marrow function or, significant anemia, leukopenia or
thrombocytopenia,

- Pregnant or nursing woman,

- Alcohol or drug abuse,

- Prior or concomitant use of cladribine, mitoxantrone, or other immunosuppressant
agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate or
mycophenolate,

- Human immunodeficiency virus (HIV) positive,

- 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
39
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Cincinnati, OH
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Bedford Park,
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Bismarck, ND
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Charleston, West Virginia 25301
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Charlotte, North Carolina 28204
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Charlotte, NC
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Clinton Township, Michigan 48035
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Clinton Township, MI
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Cordova, TN
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Dayton, OH
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Des Moines, IA
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Elk Grove Village, Illinois 60007
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Greenville, South Carolina 29615
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Philadelphia, Pennsylvania 19111
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Tupelo, MS
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