demyelinating disease Multiple Sclerosis
Conditions
Interventions
Teriflunomide 3,5
7 or 14 mg, or placebo.
Sponsors
Sanofi-aventis
Eligibility
Age
2 Years to 99 Years
Inclusion criteria
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 - Less than or equal to 17 years of age and 10 years or older 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
Exclusion criteria: - EDSS score greater than 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 - Treated with fingolimod, or intravenous immunoglobulins within 3 months prior to randomization - Treated with natalizumab, other immunosuppressant or immunomodulatory agents such as cyclophosphamide, azathioprine, cyclosporine, methotrexate, mycophenolate, within 6 months prior to randomization - Treated with 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to first clinical relapse after randomization. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Proportion of relapse free patients. - Number of of new/newly enlarged T2 lesions. - Number of T1 Gd-enhancing T1 lesions. - Change in volume of T2 lesions. - Change in volume of T1 hypointense lesions. - Number of new T1 hypointense lesions. - Proportion of patients free of new or enlarged MRI T2-lesions. - Brain atrophy. - Change in performance on symbol digit modalities test (SDMT) and Cognitive Battery Test. - Safety, as assessed by clinical, laboratory, ECG, and vital signs events. - Assessment of PK parameter - lowest concentration of drug in the blood measured after dosing (Ctrough). | — |
Countries
Netherlands
Outcome results
None listed