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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02201108




Registration number
NCT02201108
Ethics application status
Date submitted
17/07/2014
Date registered
25/07/2014

Titles & IDs
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
Secondary ID [1] 0 0
2011-005249-12
Secondary ID [2] 0 0
EFC11759
Universal Trial Number (UTN)
Trial acronym
TERIKIDS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Teriflunomide
Treatment: Drugs - Placebo

Placebo comparator: Placebo - Matching placebo tablets

Experimental: Teriflunomide - Teriflunomide oral tablet, three dosages (3.5, 7 or 14 mg) to reach 14 mg adult equivalent


Treatment: Drugs: Teriflunomide
Pharmaceutical form:film-coated tablet, Route of administration: oral

Treatment: Drugs: Placebo
Pharmaceutical form:tablet, Route of administration: oral
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to First Confirmed Clinical Relapse
Timepoint [1] 0 0
Baseline up to Week 96
Secondary outcome [1] 0 0
Probability of Participants Who Were Clinical Relapse Free at Weeks 24, 48, 72, 96, 120, 144, 168 and 192
Timepoint [1] 0 0
Weeks 24, 48, 72, 96, 120, 144, 168 and 192
Secondary outcome [2] 0 0
Brain Magnetic Resonance Imaging (MRI) Assessment: Number of New or Enlarged T2 Lesions Per MRI Scan
Timepoint [2] 0 0
Baseline up to Week 192
Secondary outcome [3] 0 0
Brain Magnetic Resonance Imaging Assessment: Number of T1 Gadolinium (Gd)-Enhancing T1 Lesions Per MRI Scan
Timepoint [3] 0 0
Baseline up to Week 192
Secondary outcome [4] 0 0
Brain Magnetic Resonance Imaging Assessment: Change From Baseline in Volume of T2 Lesions at Weeks 24, 36, 48, 72, 96, 144 and 192
Timepoint [4] 0 0
Baseline, DB period: Weeks 24, 36, 48, 72 and 96; OL period: Weeks 48, 96, 144 and 192
Secondary outcome [5] 0 0
Brain Magnetic Resonance Imaging Assessment: Change From Baseline in Volume of T1 Hypointense Lesions
Timepoint [5] 0 0
Baseline, DB period: Weeks 24, 36, 48, 72 and 96; OL period: Weeks 48, 96, 144 and 192
Secondary outcome [6] 0 0
Brain Magnetic Resonance Imaging Assessment: Number of New T1 Hypointense Lesions Per MRI Scan
Timepoint [6] 0 0
Baseline up to Week 192
Secondary outcome [7] 0 0
Brain Magnetic Resonance Imaging Assessment: Percentage of Participants Free of New or Enlarged MRI T2-Lesions
Timepoint [7] 0 0
Baseline, Weeks 24, 48, 72, 96, 144 and 192
Secondary outcome [8] 0 0
Brain Magnetic Resonance Imaging Assessment: Percent Change From Baseline in Brain Volume at Weeks 24, 36, 48, 72, 96, 144 and 192
Timepoint [8] 0 0
Baseline, DB period: Weeks 24, 36, 48, 72 and 96; OL period: Weeks 48, 96, 144 and 192
Secondary outcome [9] 0 0
Cognitive Assessment: Change From Baseline in Total Number of Correct Substitutions Measured by Symbol Digit Modalities Test (SDMT) at Weeks 24, 48, 72, 96, 120, 144, 168 and 192
Timepoint [9] 0 0
Baseline, DB period: Weeks 24, 48, 72 and 96; OL period: Weeks 24, 48, 72, 96, 120, 144, 168 and 192
Secondary outcome [10] 0 0
Cognitive Assessment: Change From Baseline in Number of Completed Items Measured by Symbol Digit Modalities Test at Weeks 24, 48, 72, 96, 120, 144, 168 and 192
Timepoint [10] 0 0
Baseline, DB period: Weeks 24, 48, 72 and 96; OL period: Weeks 24, 48, 72, 96, 120, 144, 168 and 192
Secondary outcome [11] 0 0
Cognitive Assessment: Change From Baseline in Brief Visuospatial Memory Test-Revised (BVMT-R) Scores at Weeks 96 and 192
Timepoint [11] 0 0
Baseline, Weeks 96 and 192
Secondary outcome [12] 0 0
Cognitive Assessment: Change From Baseline in Trail Making Test- Part A (TMT-A) Test Scores (in Seconds) at Week 96 and 192
Timepoint [12] 0 0
Baseline, Weeks 96 and 192
Secondary outcome [13] 0 0
Cognitive Assessment: Change From Baseline in Trail Making Test B (TMT-B) Test Scores (in Seconds) at Weeks 96 and 192
Timepoint [13] 0 0
Baseline, Weeks 96 and 192
Secondary outcome [14] 0 0
Cognitive Assessment: Change From Baseline in Beery Visual-motor Integration (BVMI) Scores at Weeks 96 and 192
Timepoint [14] 0 0
Baseline, Weeks 96 and 192
Secondary outcome [15] 0 0
Cognitive Assessment: Change From Baseline in Wechsler Abbreviated Scale of Intelligence-II (WASI-II) Vocabulary Total Raw Scores at Weeks 96 and 192
Timepoint [15] 0 0
Baseline, Weeks 96 and 192
Secondary outcome [16] 0 0
Cognitive Assessment: Change From Baseline in Delis-Kaplan Executive Function System (D-KEFS) Letter Fluency Total Correct Raw Score at Weeks 96 and 192
Timepoint [16] 0 0
Baseline, Weeks 96 and 192
Secondary outcome [17] 0 0
Cognitive Assessment: Change From Baseline in Delis-Kaplan Executive Function System Category Fluency Total Correct Raw Score at Weeks 96 and 192
Timepoint [17] 0 0
Baseline, Weeks 96 and 192
Secondary outcome [18] 0 0
Cognitive Assessment - Selective Reminding Test (SRT): Change From Baseline in Total Number of Words on Delayed Recall at Weeks 96 and 192
Timepoint [18] 0 0
Baseline, Weeks 96 and 192
Secondary outcome [19] 0 0
DB: Pharmacokinetics: Steady-state Trough Concentration (Ctrough) of Teriflunomide
Timepoint [19] 0 0
Predose on Week 36
Secondary outcome [20] 0 0
OL: Time to First Confirmed Clinical Relapse
Timepoint [20] 0 0
Baseline up to Week 192
Secondary outcome [21] 0 0
OL: Pharmacokinetics: Steady-state Trough Concentration (Ctrough) of Teriflunomide
Timepoint [21] 0 0
Pre-dose at Week 36

Eligibility
Key inclusion criteria
* Participants with relapsing MS were eligible. Participants who met the criteria of MS based on McDonald criteria 2010 and International Pediatric Multiple Sclerosis Study Group (IPMSSG) criteria for pediatric MS, version of 2012 and had:

* at least one relapse (or attack) in the 12 months preceding screening or,
* at least two relapses (or attack) in the 24 months preceding screening.
* Less than 18 years of age and greater than or equal to (>=) 10 years of age at randomization. Specific for the Russian Federation from 18 December 2014 to 26 July 2016, less than or equal to 17 years of age and >= 13 years of age at randomization.
* Signed informed consent/assent obtained from participant and participant's legal representative (parents or guardians) according to local regulations.
Minimum age
10 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

* Expanded disability status scale score greater than 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 human immunodeficiency virus infection.
* Contraindication for MRI.
* Pregnant or breast-feeding females or those who plan to become pregnant during the study.
* Female participants of child-bearing potential not using highly effective contraceptive method (contraception in both female and male was required).

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/07/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
25/06/2025
Actual
Sample size
Target
Accrual to date
Final
166
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Massachusetts
Country [4] 0 0
United States of America
State/province [4] 0 0
North Carolina
Country [5] 0 0
Belgium
State/province [5] 0 0
Gent
Country [6] 0 0
Belgium
State/province [6] 0 0
Leuven
Country [7] 0 0
Bulgaria
State/province [7] 0 0
Sofia
Country [8] 0 0
Canada
State/province [8] 0 0
Alberta
Country [9] 0 0
China
State/province [9] 0 0
Beijing
Country [10] 0 0
China
State/province [10] 0 0
Changchun
Country [11] 0 0
China
State/province [11] 0 0
Changsha
Country [12] 0 0
China
State/province [12] 0 0
Chengdu
Country [13] 0 0
China
State/province [13] 0 0
Chongqing
Country [14] 0 0
China
State/province [14] 0 0
Guangzhou
Country [15] 0 0
China
State/province [15] 0 0
Shanghai
Country [16] 0 0
China
State/province [16] 0 0
Shijiazhuang
Country [17] 0 0
China
State/province [17] 0 0
Taiyuan
Country [18] 0 0
Estonia
State/province [18] 0 0
Tallinn
Country [19] 0 0
France
State/province [19] 0 0
Le Kremlin Bicetre
Country [20] 0 0
France
State/province [20] 0 0
Lyon Cedex 03
Country [21] 0 0
France
State/province [21] 0 0
Rennes Cedex
Country [22] 0 0
France
State/province [22] 0 0
Toulouse
Country [23] 0 0
Greece
State/province [23] 0 0
Athens
Country [24] 0 0
Greece
State/province [24] 0 0
Thessaloniki
Country [25] 0 0
Israel
State/province [25] 0 0
Jerusalem
Country [26] 0 0
Israel
State/province [26] 0 0
Tel HaShomer
Country [27] 0 0
Lebanon
State/province [27] 0 0
Beirut
Country [28] 0 0
Lithuania
State/province [28] 0 0
Kaunas
Country [29] 0 0
Morocco
State/province [29] 0 0
FES
Country [30] 0 0
Morocco
State/province [30] 0 0
Marrakech
Country [31] 0 0
Netherlands
State/province [31] 0 0
Rotterdam
Country [32] 0 0
Portugal
State/province [32] 0 0
Coimbra
Country [33] 0 0
Russian Federation
State/province [33] 0 0
Moscow
Country [34] 0 0
Russian Federation
State/province [34] 0 0
Nizhny Novgorod
Country [35] 0 0
Russian Federation
State/province [35] 0 0
Novosibirsk
Country [36] 0 0
Russian Federation
State/province [36] 0 0
Saint-Petersburg
Country [37] 0 0
Serbia
State/province [37] 0 0
Belgrade
Country [38] 0 0
Spain
State/province [38] 0 0
Murcia
Country [39] 0 0
Tunisia
State/province [39] 0 0
La Manouba
Country [40] 0 0
Tunisia
State/province [40] 0 0
Sfax
Country [41] 0 0
Turkey
State/province [41] 0 0
Ankara
Country [42] 0 0
Turkey
State/province [42] 0 0
Istanbul
Country [43] 0 0
Turkey
State/province [43] 0 0
Izmir
Country [44] 0 0
Ukraine
State/province [44] 0 0
Kharkiv
Country [45] 0 0
United Kingdom
State/province [45] 0 0
London, City Of
Country [46] 0 0
United Kingdom
State/province [46] 0 0
Birmingham

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Genzyme, a Sanofi Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Sciences & Operations
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02201108