Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT02201108 : Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients With Relapsing Forms of Multiple Sclerosis
PhasePhase 3
AgesMin: 10 Years Max: 17 Years
Eligibility
Inclusion criteria:

- Patients with relapsing multiple sclerosis are eligible. Patients should meet the
criteria of MS based on McDonald criteria 2010 and International Pediatric Multiple
Sclerosis Study Group (IPMSSG) criteria for pediatric MS, version of 2012 (5) and
have:

- at least one relapse (or attack) in the 12 months preceding randomization or

- at least two relapses (or attack) in the 24 months preceding randomization.

- ?17 years of age and ?10 years of age at randomization.

- Signed informed consent/assent obtained from patient and patient's legal
representative (parents or guardians) according to local regulations.

Exclusion criteria:

- EDSS score > 5.5 at screening or randomization visits.

- Relapse within 30 days prior to randomization.

- Treated with:

- glatiramer acetate, interferons, or dimethyl fumarate within 1 month prior to
randomization

- fingolimod, or intravenous immunoglobulins within 3 months prior to
randomization

- natalizumab, other immunosuppressant or immunomodulatory agents such as
cyclophosphamide, azathioprine, cyclosporine, methotrexate, mycophenolate,
within 6 months prior to randomization,

- cladribine or mitoxantrone within 2 years prior to randomization.

- Treated with alemtuzumab at any time.

- History of HIV infection.

- Contraindication for MRI.

- Pregnant or breast-feeding females or those who plan to become pregnant during the
study.

- Female patients of child-bearing potential not using highly effective contraceptive
method (contraception in both female and male is required).

The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02201108      |      Link to official Clinicaltrials.gov listing
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