Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients with Relapsing Forms of Multiple Sclerosis

Phase 1

Active, not recruiting

• Conditions: Multiple Sclerosis; MedDRA version: 17.0Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02-27
• Last Update Posted: 21 March 2022

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 166

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 (IPMSG) criteria for pediatric MS, version of 2012 (5) 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.

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

• 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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified