Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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1 February 2016 |
Main ID: |
EUCTR2011-005249-12-PL |
Date of registration:
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07/07/2014 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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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
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Scientific title:
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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 with Relapsing Forms of Multiple Sclerosis Followed by
an Open-Label Extension
- TERIKIDS |
Date of first enrolment:
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11/06/2015 |
Target sample size:
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165 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-005249-12 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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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
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Phase:
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Countries of recruitment
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Australia
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Belgium
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Canada
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China
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Estonia
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Greece
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Israel
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Lebanon
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Lithuania
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Poland
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Russian Federation
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Spain
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Turkey
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United Kingdom
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United States
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Contacts
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Name:
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Address:
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ul. Bonifraterska 17
00-203
Warszawa
Poland |
Telephone:
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+482228 00 000 |
Email:
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informacja.medyczna@sanofi.com |
Affiliation:
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Sanofi-Aventis Sp. z o.o. |
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Name:
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Address:
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ul. Bonifraterska 17
00-203
Warszawa
Poland |
Telephone:
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+482228 00 000 |
Email:
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informacja.medyczna@sanofi.com |
Affiliation:
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Sanofi-Aventis Sp. z o.o. |
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Key inclusion & exclusion criteria
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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 (IPMSSG) criteria for pediatric MS, version of 2012 (5) and 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
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Health Condition(s) or Problem(s) studied
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Multiple Sclerosis MedDRA version: 18.0
Level: PT
Classification code 10028245
Term: Multiple sclerosis
System Organ Class: 10029205 - Nervous system disorders
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Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
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Intervention(s)
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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
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Primary Outcome(s)
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Timepoint(s) of evaluation of this end point: Over 96 weeks
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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.
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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.
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Primary end point(s): Time to first clinical relapse after randomization
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Secondary Outcome(s)
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Secondary end point(s): 3 - Number 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)
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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
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Secondary ID(s)
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2011-005249-12-EE
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EFC11759
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Source(s) of Monetary Support
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Genzyme Corporation
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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