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

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 - TERIKIDS

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-005249-12-ES

Enrollment

165

Registered

2014-04-01

Start date

2014-06-03

Completion date

Unknown

Last updated

2019-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis MedDRA version: 16.1 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders

Interventions

Product Name: Teriflunomide Product Code: HMR1726 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: TERIFLUNOMIDE CAS Number:

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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.; Secondary Objective: To assess the effect of teriflunomide in comparison to placebo on disease activity/progression measured by brain MRI and on cognitive function. To evaluate the safety and tolerability of teriflunomide in comparison to placebo. To evaluate the pharmacokinetics (PK) of teriflunomide. ;Primary end point(s): Time to first clinical relapse after randomization;Timepoint(s) of evaluation of this end point: Over 96 weeks	—

Measure

Time frame

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.; Secondary Objective: To assess the effect of teriflunomide in comparison to placebo on disease activity/progression measured by brain MRI and on cognitive function. To evaluate the safety and tolerability of teriflunomide in comparison to placebo. To evaluate the pharmacokinetics (PK) of teriflunomide. ;Primary end point(s): Time to first clinical relapse after randomization;Timepoint(s) of evaluation of this end point: Over 96 weeks

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Secondary

Measure	Time frame
Secondary end point(s): 1 - Proportion of relapse free patients 2 - Number of of new/newly enlarged T2 lesions 3 - Number of T1 Gd-enhancing T1 lesions 4 - Change in volume of T2 lesions 5 - Change in volume of T1 hypointense lesions 6 - Number of new T1 hypointense lesions 7 - Change in brain atrophy 8 - Change in performance on symbol digit modalities test (SDMT) and Cognitive Battery Test 9 - Overview of safety including adverse events (AEs) based on AE reporting, physical examinations, vital signs, clinical laboratories, suspected neuropathy, electrocardiography (ECG), suspected infection 10 - Teriflunomide pharmacokinetics (PK) to allow the dose adjustment to the 14 mg adult equivalent dose for the rest of the study ; Timepoint(s) of evaluation of this end point: 1 and 9 : Over 96 weeks 2, 3, 4, 5, 6 and 7 : At randomization, at 24, 48 and 96 weeks 8 : At randomization, then every 24 weeks (SDMT only) and at 96 weeks 10 : A total of 3 PK samples (blood samples) will be collected during the beginning of study, i.e., the 4-week PK run-in period (weeks 2, 3 and 4); patients entering the open label teriflunomide arm will re-do PK run-in (3 blood samples)	—

Measure

Time frame

Secondary end point(s): 1 - Proportion of relapse free patients 2 - Number of of new/newly enlarged T2 lesions 3 - Number of T1 Gd-enhancing T1 lesions 4 - Change in volume of T2 lesions 5 - Change in volume of T1 hypointense lesions 6 - Number of new T1 hypointense lesions 7 - Change in brain atrophy 8 - Change in performance on symbol digit modalities test (SDMT) and Cognitive Battery Test 9 - Overview of safety including adverse events (AEs) based on AE reporting, physical examinations, vital signs, clinical laboratories, suspected neuropathy, electrocardiography (ECG), suspected infection 10 - Teriflunomide pharmacokinetics (PK) to allow the dose adjustment to the 14 mg adult equivalent dose for the rest of the study ; Timepoint(s) of evaluation of this end point: 1 and 9 : Over 96 weeks 2, 3, 4, 5, 6 and 7 : At randomization, at 24, 48 and 96 weeks 8 : At randomization, then every 24 weeks (SDMT only) and at 96 weeks 10 : A total of 3 PK samples (blood samples) will be collected during the beginning of study, i.e., the 4-week PK run-in period (weeks 2, 3 and 4); patients entering the open label teriflunomide arm will re-do PK run-in (3 blood samples)

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Countries

Australia, Belgium, Bulgaria, Canada, China, Estonia, France, Greece, Ireland, Israel, Lebanon, Lithuania, Netherlands, Poland, Portugal, Russian Federation, Slovenia, Spain, Turkey, United Kingdom, United States

Contacts

Public ContactUnidad Estudios Clínicos

sanofi-aventis, s.a.

ES-unidadestudiosclinicos@sanofi.com93 485 94 00

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026