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

• Register: EUCTR
• Last refreshed on: 21 March 2022
• Main ID: EUCTR2011-005249-12-EE
• Date of registration: 27/02/2014
• Prospective Registration: Yes
• Primary sponsor: Genzyme Corporation
• Public title: Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients with Relapsing Forms of Multiple Sclerosis
• Scientific title: 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 Extension - TERIKIDS
• Date of first enrolment: 13/08/2014
• Target sample size: 165
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-005249-12
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; Cross over: no; Other: yes; Other trial design description: Option to go in an open label teriflunomide arm for patients having a relapse after PK run-in phase; If controlled, specify comparator, Other Medicinial Product: no; Placebo: yes; Other: no; Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

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

Contacts

• Name: Clinical Study Unit
• Affiliation: sanofi-aventis Estonia OÜ

• Name: Clinical Study Unit
• Affiliation: sanofi-aventis Estonia OÜ

Key inclusion & exclusion criteria

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).



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Multiple Sclerosis
MedDRA version: 17.0 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Intervention(s)

Product Name: Teriflunomide
Product Code: HMR1726
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: TERIFLUNOMIDE
CAS Number: 108605-62-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 14-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Product Name: Teriflunomide
Product Code: HMR1726
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: TERIFLUNOMIDE
CAS Number: 108605-62-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 7-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Product Name: Teriflunomide
Product Code: HMR1726
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: TERIFLUNOMIDE
CAS Number: 108605-62-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 3.5-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Primary end point(s): 1 - Time to first clinical relapse after randomization

Timepoint(s) of evaluation of this end point: Over 96 weeks

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.

Secondary Outcome(s)

Secondary end point(s): 2 - Proportion of relapse free patients
3 - Number of of new/newly enlarged T2 lesions
4 - Number of T1 Gd-enhancing T1 lesions
5 - Change in volume of T2 lesions
- Change in volume of T1 hypointense lesions
6 - Number of new T1 hypointense lesions
7 - Proportion of patients free of new or enlarged MRI T2-lesions
8 - Brain atrophy
9 - Change in performance on symbol digit modalities test (SDMT) and Cognitive Battery Test
10 - Safety, as assessed by clinical, laboratory, ECG, and vital signs events
11 - Teriflunomide pharmacokinetics (PK)

Timepoint(s) of evaluation of this end point: 2: at 24, 48, 72 and 96 weeks
3, 4, 5, 6, 8 and 10: over 96 weeks
7: at 48 weeks and 96 weeks
9: at randomization, then every 24 weeks (SDMT only) and at 96 weeks
11: at Weeks 2, 3, 4, 8, 12, 24, 36 and EOT

Secondary ID(s)

EFC11759

Source(s) of Monetary Support

Genzyme Corporation

Ethics review

Status: Approved
Approval date: 25/03/2014
Contact:

Results

• Results available: Yes
• Date Posted: 29/01/2021
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2011-005249-12/results