A two year, randomized, placebo-controlled study to evaluate efficacy, safety, tolerability, and pharmacokinetics of teriflunomide once daily in pediatric patients with relapsing forms of multiple sclerosis
- Conditions
- Multiple SclerosisMedDRA version: 16.1 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2011-005249-12-ES
- Lead Sponsor
- Genzyme Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 165
- Patients with relapsing multiple sclerosis (MS) based on McDonald criteria of 2010 and International Pediatric Multiple Sclerosis Study Group (IPMSG) criteria for pediatric MS:
-at least one relapse in the 12 months preceding randomization, or
-at least 2 relapses in the 24 months preceding randomization.
- Equal or less than 17 years of age and equal or greater than 10 years of age at randomization.
- Signed informed consent/assent obtained from patient and patient's legal representative.
Are the trial subjects under 18? yes
Number of subjects for this age range: 165
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
- Expanded disability status scale (EDSS) score greater than 5.5 at screening or randomization visit.
- Relapse within 30 days prior to randomization.
- Treated with cladribine or mitoxantrone within 2 years preceding randomization.
- Treated with glatiramer acetate, interferons, natalizumab, introvenous immunoglobulins or other immunosuppressant or immunomodulatory agents such as cyclophosphamide, azathioprine, cyclosporine, methotrexate, mycophenolate, dimetthyl fumrate, fingolimod less than 3 months or five half-lives prior to randomization, whichever is greater.
- History of human immunodeficiency virus (HIV) infection.
- Contraindication for magnetic resonance imaging (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 contraceptives or (double barrier) contraceptive method.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the effect of teriflunomide in comparison to placebo on disease activity measured by time to first clinical relapse after randomization in children and adolescents 10 to 17 years of age with relapsing forms of multiple sclerosis.;<br> Secondary Objective: To assess the effect of teriflunomide in comparison to placebo on disease activity/progression measured by brain MRI and on cognitive function.<br> To evaluate the safety and tolerability of teriflunomide in comparison to placebo.<br> To evaluate the pharmacokinetics (PK) of teriflunomide.<br> ;Primary end point(s): Time to first clinical relapse after randomization;Timepoint(s) of evaluation of this end point: Over 96 weeks
- Secondary Outcome Measures
Name Time Method