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

Phase 1

• Conditions: Multiple Sclerosis; MedDRA version: 18.0Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2011-005249-12-FR
• Lead Sponsor: Genzyme Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-06-17
• Last Update Posted: 25 April 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 166

Inclusion Criteria

- 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

Exclusion Criteria

- 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