A Two Year, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of Teriflunomide Administered Orally Once Daily in Pediatric Patients with Relapsing Forms of Multiple Sclerosis Followed by an Open-Label Extensio
- Conditions
- demyelinating diseaseMultiple Sclerosis10012303
- Registration Number
- NL-OMON47604
- Lead Sponsor
- Sanofi-aventis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 2
-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.
- 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).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Time to first clinical relapse after randomization.</p><br>
- Secondary Outcome Measures
Name Time Method <p>- Proportion of relapse free patients.<br /><br>- Number of of new/newly enlarged T2 lesions.<br /><br>- Number of T1 Gd-enhancing T1 lesions.<br /><br>- Change in volume of T2 lesions.<br /><br>- Change in volume of T1 hypointense lesions.<br /><br>- Number of new T1 hypointense lesions.<br /><br>- Proportion of patients free of new or enlarged MRI T2-lesions.<br /><br>- Brain atrophy.<br /><br>- Change in performance on symbol digit modalities test (SDMT) and Cognitive<br /><br>Battery Test.<br /><br>- Safety, as assessed by clinical, laboratory, ECG, and vital signs events.<br /><br>- Assessment of PK parameter - lowest concentration of drug in the blood<br /><br>measured after dosing (Ctrough).</p><br>