Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
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
Query!
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
Query!
Secondary ID [1]
0
0
2011-005249-12
Query!
Secondary ID [2]
0
0
EFC11759
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
TERIKIDS
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis
0
0
Query!
Condition category
Condition code
Intervention/exposure
Study type
Interventional
Query!
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
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Time to First Confirmed Clinical Relapse
Query!
Assessment method [1]
0
0
Time to first clinical relapse was defined as the duration (in weeks) between randomization and first confirmed clinical relapse. Clinical relapses were defined as new or recurrent neurological symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon neurological examination and documented by a standardized, quantified functional system score (FSSs) which included 8 items and items were rated on different scales: brain stem, cerebellar and cerebral functions rated on a scale of 0 to 5; visual, pyramidal, sensory and bowel/bladder rated on a scale of 0 to 6 and ambulation on a scale of 0 to 12, where higher score in each scale indicated worsened neurological function. Confirmed clinical relapse were reviewed and confirmed by an independent Relapse Adjudication Panel (RAP). A participant without confirmed clinical relapse, was considered as clinical relapse free until the end of Week 96.
Query!
Timepoint [1]
0
0
Baseline up to Week 96
Query!
Secondary outcome [1]
0
0
Probability of Participants Who Were Clinical Relapse Free at Weeks 24, 48, 72, 96, 120, 144, 168 and 192
Query!
Assessment method [1]
0
0
Participant was considered free of clinical relapse if the participant had no confirmed clinical relapse before treatment discontinuation/completion in 192 weeks treatment period. Clinical relapses: new/recurrent neurological symptoms not associated with fever/infection, lasted at least 24 hours, and accompanied by new objective neurological findings upon neurological examination and documented by standardized, quantified FSSs which included 8 items: rated on different scales: brain stem, cerebellar and cerebral functions rated on scale of 0 to 5; visual, pyramidal, sensory and bowel/bladder rated on scale of 0 to 6 \& ambulation on scale of 0 to 12, where higher score in each scale indicated worsened neurological function. New/recurrent symptoms occurred less than 30 days following onset of relapse were considered part of same relapse. Probability of participants who were clinical relapse free at specified weeks were estimated by Kaplan-Meier method and reported.
Query!
Timepoint [1]
0
0
Weeks 24, 48, 72, 96, 120, 144, 168 and 192
Query!
Secondary outcome [2]
0
0
Brain Magnetic Resonance Imaging (MRI) Assessment: Number of New or Enlarged T2 Lesions Per MRI Scan
Query!
Assessment method [2]
0
0
Number of new or enlarged T2 lesions per scan was defined as the total number of new or enlarged T2 lesion that occurred during the 192 weeks treatment period divided by the total number of scans performed during 192 weeks. To account for the different numbers of scans performed among the participants, a negative binomial regression model with robust variance estimation was used. The model included the total number of new or enlarged T2-lesions as the response variable, with treatment group, region, pubertal status and age as covariates and log-transformed number of scans as an offset variable.
Query!
Timepoint [2]
0
0
Baseline up to Week 192
Query!
Secondary outcome [3]
0
0
Brain Magnetic Resonance Imaging Assessment: Number of T1 Gadolinium (Gd)-Enhancing T1 Lesions Per MRI Scan
Query!
Assessment method [3]
0
0
The number of T1 Gd-Enhancing lesions per scan was defined as the total number of Gd-enhancing lesions that occurred during the 192 weeks treatment period divided by the total number of scans performed during 192 weeks. To account for the different number of scans performed among the participants, a negative binomial regression model with robust variance estimation was used. The model included the total number of T1-lesions as the response variable, with treatment group, region, pubertal status and age as covariates and log-transformed number of scans as an offset variable.
Query!
Timepoint [3]
0
0
Baseline up to Week 192
Query!
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
Query!
Assessment method [4]
0
0
Volume of T2 lesions was measured by MRI scan.
Query!
Timepoint [4]
0
0
Baseline, DB period: Weeks 24, 36, 48, 72 and 96; OL period: Weeks 48, 96, 144 and 192
Query!
Secondary outcome [5]
0
0
Brain Magnetic Resonance Imaging Assessment: Change From Baseline in Volume of T1 Hypointense Lesions
Query!
Assessment method [5]
0
0
Volume of T1 hypointense lesions was measured by MRI scan.
Query!
Timepoint [5]
0
0
Baseline, DB period: Weeks 24, 36, 48, 72 and 96; OL period: Weeks 48, 96, 144 and 192
Query!
Secondary outcome [6]
0
0
Brain Magnetic Resonance Imaging Assessment: Number of New T1 Hypointense Lesions Per MRI Scan
Query!
Assessment method [6]
0
0
The number of new T1 hypointense lesions were obtained from MRI scans.
Query!
Timepoint [6]
0
0
Baseline up to Week 192
Query!
Secondary outcome [7]
0
0
Brain Magnetic Resonance Imaging Assessment: Percentage of Participants Free of New or Enlarged MRI T2-Lesions
Query!
Assessment method [7]
0
0
Percentage of participants who were free of new or enlarged T2 lesions at Weeks 24, 48, 72, 96, 144 and 192 were reported.
Query!
Timepoint [7]
0
0
Baseline, Weeks 24, 48, 72, 96, 144 and 192
Query!
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
Query!
Assessment method [8]
0
0
Percent change from baseline in brain volume (assessed using MRI scans of the Brain) at Weeks 24, 36, 48,72, 96, 144 and 192 was reported.
Query!
Timepoint [8]
0
0
Baseline, DB period: Weeks 24, 36, 48, 72 and 96; OL period: Weeks 48, 96, 144 and 192
Query!
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
Query!
Assessment method [9]
0
0
SDMT measures the time to pair abstract symbols with specific numbers. It is a simple substitution task that gives the examinee 90 seconds to pair specific numbers with given geometric figures as a measure for screening cognitive impairment. The SDMT score is the number of correct substitution and ranged from 0 (worst outcome) to 110 (best outcome), where higher score indicated better cognitive function.
Query!
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
Query!
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
Query!
Assessment method [10]
0
0
SDMT measures the time to pair abstract symbols with specific numbers. It is a simple substitution task that gives the examinee 90 seconds to pair specific numbers with given geometric figures as a measure for screening cognitive impairment. The SDMT score is the number of completed items and ranged from 0 (worst outcome) to 110 (best outcome), where higher score indicated better cognitive function.
Query!
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
Query!
Secondary outcome [11]
0
0
Cognitive Assessment: Change From Baseline in Brief Visuospatial Memory Test-Revised (BVMT-R) Scores at Weeks 96 and 192
Query!
Assessment method [11]
0
0
The BVMT consists of three trials in which participants must recall shapes by drawing figures on a blank page (response booklet) after being given the opportunity to memorize the figures (given in BMVT-R form) for 10 seconds. BMVT-R form consists of six figures. Points are awarded based on the accuracy of the drawn figure and by correct placement on the blank page. A minimum of 0 to 12 points/scores are awarded per trial, so a participant can score between 0 and 36 points for all three trials (by adding the points/score from each trial), where higher score indicates better outcome.
Query!
Timepoint [11]
0
0
Baseline, Weeks 96 and 192
Query!
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
Query!
Assessment method [12]
0
0
'Trail Making Test Part A' is a neuropsychological test of visual attention and task switching. The task requires a participant to 'connect-the-dots' of 25 consecutive numbers (1,2, 3, etc.) in sequential order on a sheet of paper or computer screen. The goal of the participant is to finish the test as quickly as possible, and the time taken to complete the test used as the primary performance metric (in seconds). This is a timed test and the number of seconds to complete the task is recorded. Maximum time allowed is 300 seconds. A lower score indicated better cognitive function.
Query!
Timepoint [12]
0
0
Baseline, Weeks 96 and 192
Query!
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
Query!
Assessment method [13]
0
0
TMT-B is a cognitive test that gives a measure of various aspects of cognitive performance. It is used to measure cognitive fatigue. The test consisted of 25 circles containing 13 sequential numbers (1 to 13) and 12 sequential letters (A to L) positioned. The test evaluates the time (in seconds) to correctly order letters and numbers in alternate order (1, A, 2, B etc.). Maximum time allowed is 300 seconds, where less time/lower score indicated better cognitive function/performance.
Query!
Timepoint [13]
0
0
Baseline, Weeks 96 and 192
Query!
Secondary outcome [14]
0
0
Cognitive Assessment: Change From Baseline in Beery Visual-motor Integration (BVMI) Scores at Weeks 96 and 192
Query!
Assessment method [14]
0
0
The Beery VMI is a non-verbal assessment that assessed the extent to which individuals can integrate their visual and motor abilities. The participants were provided with geometric designs ranging from simple line drawings to more complex figures and were asked to copy the designs. The test consisted of 24 figures. One point was scored for each successful copy of drawings and no scoring was given when the participant failed to copy the drawings properly. Each successful copying of drawings was summed up and the total was scored on a scale ranged from 0 to 24, where higher score indicated better visual construction skills/better visual and motor abilities and lower score indicated poor visual construction skills/poor visual and motor abilities.
Query!
Timepoint [14]
0
0
Baseline, Weeks 96 and 192
Query!
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
Query!
Assessment method [15]
0
0
The WASI-II: Vocabulary test is a quick estimate of an individual's level of intellectual functioning which comprised of 31 total items that required the participant to orally define 3 images and 28 words presented both orally and visually. Items 1 to 3 rated on a score of 0 or 1, items 4 and 5 rated on a score of 0 or 2, items 6 to 31 rated on a scale of 0 to 2. Each item score was summed up to derive the total score which ranged from 0 (minimum score) to 59 (maximum score), where higher score indicated better level of intellectual functioning/higher level of intelligence.
Query!
Timepoint [15]
0
0
Baseline, Weeks 96 and 192
Query!
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
Query!
Assessment method [16]
0
0
Letter Fluency is a condition measured in the D-KEFS. Participants were asked to name as many words as they can, starting with a specified letter for 60 seconds. The words cannot be names, places, numbers or grammatical variants of previous answers. Repeated answers were not scored as a correct response. There were 3 trials, with 3 different letters. The total number of correct responses was totaled for all 3 trials and a letter fluency score was given. A higher score was considered better. There was no set range as the score depends on how many correct words the participant relays in the given time period.
Query!
Timepoint [16]
0
0
Baseline, Weeks 96 and 192
Query!
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
Query!
Assessment method [17]
0
0
Category Fluency is a condition measured in the D-KEFS. It measured participant's ability to generate words from three different categories (e.g., fruits, vegetables and animals), within a minute for each category. Total score was number of correct words for each category with no points for repetitions or non-words. Score ranged from 0 to unlimited, where 0 = low score, higher score indicated better performance.
Query!
Timepoint [17]
0
0
Baseline, Weeks 96 and 192
Query!
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
Query!
Assessment method [18]
0
0
SRT is a test to assess verbal learning and memory. During the administration of the SRT only the examiner and the participant should be in the testing room. A list of twelve words was read aloud by the examiner at a rate of one word per two seconds. The participant is asked to recall all twelve words after a 30 minute delay. Only the words that were missed on the preceding trial were given in the consecutive trial. The total score represented a sum score of total 6 trials, therefore the score range was from 0 to 72. The lower the score the worse the outcome, higher score indicated better recall.
Query!
Timepoint [18]
0
0
Baseline, Weeks 96 and 192
Query!
Secondary outcome [19]
0
0
DB: Pharmacokinetics: Steady-state Trough Concentration (Ctrough) of Teriflunomide
Query!
Assessment method [19]
0
0
Ctrough was defined as the concentration reached by the drug before the next dose administered. Data for this outcome measure was planned to be collected and analyzed separately for each dose of Teriflunomide. PK samples for teriflunomide 3.5 mg were collected during the first 8 weeks but all participants were switched to teriflunomide 7 mg after Week 8. Hence, plasma concentration of teriflunomide 7 mg and 14 mg were reported.
Query!
Timepoint [19]
0
0
Predose on Week 36
Query!
Secondary outcome [20]
0
0
OL: Time to First Confirmed Clinical Relapse
Query!
Assessment method [20]
0
0
Time to first clinical relapse was defined as duration (in weeks) after enrollment in OL period and first confirmed clinical relapse. Clinical relapses were defined as new or recurrent neurological symptoms not associated with fever or infection, lasted at least 24 hours and accompanied by new objective neurological findings upon neurological examination and documented by standardized, quantified FSSs which included 8 items and items were rated on different scales: brain stem, cerebellar \& cerebral functions rated on scale of 0 to 5; visual, pyramidal, sensory and bowel/bladder rated on scale of 0 to 6 and ambulation on scale of 0 to 12 where higher score in each scale indicated worsened neurological function. Confirmed clinical relapse were reviewed and confirmed by independent RAP. Participant without confirmed clinical relapse, was considered as clinical relapse free until end of Week 192.
Query!
Timepoint [20]
0
0
Baseline up to Week 192
Query!
Secondary outcome [21]
0
0
OL: Pharmacokinetics: Steady-state Trough Concentration (Ctrough) of Teriflunomide
Query!
Assessment method [21]
0
0
Ctrough was defined as the concentration reached by the drug before the next dose is administered. Data for this outcome measure was planned to be collected and analyzed separately for each dose of teriflunomide. PK samples for teriflunomide 3.5 mg were collected during the first 8 weeks but all participants were switched to teriflunomide 7 mg after Week 8. Hence, plasma concentration of teriflunomide 7 mg and 14 mg were reported.
Query!
Timepoint [21]
0
0
Pre-dose at Week 36
Query!
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.
Query!
Minimum age
10
Years
Query!
Query!
Maximum age
17
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
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
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Active, not recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
16/07/2014
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
25/06/2025
Query!
Actual
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
166
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Florida
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Massachusetts
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
North Carolina
Query!
Country [5]
0
0
Belgium
Query!
State/province [5]
0
0
Gent
Query!
Country [6]
0
0
Belgium
Query!
State/province [6]
0
0
Leuven
Query!
Country [7]
0
0
Bulgaria
Query!
State/province [7]
0
0
Sofia
Query!
Country [8]
0
0
Canada
Query!
State/province [8]
0
0
Alberta
Query!
Country [9]
0
0
China
Query!
State/province [9]
0
0
Beijing
Query!
Country [10]
0
0
China
Query!
State/province [10]
0
0
Changchun
Query!
Country [11]
0
0
China
Query!
State/province [11]
0
0
Changsha
Query!
Country [12]
0
0
China
Query!
State/province [12]
0
0
Chengdu
Query!
Country [13]
0
0
China
Query!
State/province [13]
0
0
Chongqing
Query!
Country [14]
0
0
China
Query!
State/province [14]
0
0
Guangzhou
Query!
Country [15]
0
0
China
Query!
State/province [15]
0
0
Shanghai
Query!
Country [16]
0
0
China
Query!
State/province [16]
0
0
Shijiazhuang
Query!
Country [17]
0
0
China
Query!
State/province [17]
0
0
Taiyuan
Query!
Country [18]
0
0
Estonia
Query!
State/province [18]
0
0
Tallinn
Query!
Country [19]
0
0
France
Query!
State/province [19]
0
0
Le Kremlin Bicetre
Query!
Country [20]
0
0
France
Query!
State/province [20]
0
0
Lyon Cedex 03
Query!
Country [21]
0
0
France
Query!
State/province [21]
0
0
Rennes Cedex
Query!
Country [22]
0
0
France
Query!
State/province [22]
0
0
Toulouse
Query!
Country [23]
0
0
Greece
Query!
State/province [23]
0
0
Athens
Query!
Country [24]
0
0
Greece
Query!
State/province [24]
0
0
Thessaloniki
Query!
Country [25]
0
0
Israel
Query!
State/province [25]
0
0
Jerusalem
Query!
Country [26]
0
0
Israel
Query!
State/province [26]
0
0
Tel HaShomer
Query!
Country [27]
0
0
Lebanon
Query!
State/province [27]
0
0
Beirut
Query!
Country [28]
0
0
Lithuania
Query!
State/province [28]
0
0
Kaunas
Query!
Country [29]
0
0
Morocco
Query!
State/province [29]
0
0
FES
Query!
Country [30]
0
0
Morocco
Query!
State/province [30]
0
0
Marrakech
Query!
Country [31]
0
0
Netherlands
Query!
State/province [31]
0
0
Rotterdam
Query!
Country [32]
0
0
Portugal
Query!
State/province [32]
0
0
Coimbra
Query!
Country [33]
0
0
Russian Federation
Query!
State/province [33]
0
0
Moscow
Query!
Country [34]
0
0
Russian Federation
Query!
State/province [34]
0
0
Nizhny Novgorod
Query!
Country [35]
0
0
Russian Federation
Query!
State/province [35]
0
0
Novosibirsk
Query!
Country [36]
0
0
Russian Federation
Query!
State/province [36]
0
0
Saint-Petersburg
Query!
Country [37]
0
0
Serbia
Query!
State/province [37]
0
0
Belgrade
Query!
Country [38]
0
0
Spain
Query!
State/province [38]
0
0
Murcia
Query!
Country [39]
0
0
Tunisia
Query!
State/province [39]
0
0
La Manouba
Query!
Country [40]
0
0
Tunisia
Query!
State/province [40]
0
0
Sfax
Query!
Country [41]
0
0
Turkey
Query!
State/province [41]
0
0
Ankara
Query!
Country [42]
0
0
Turkey
Query!
State/province [42]
0
0
Istanbul
Query!
Country [43]
0
0
Turkey
Query!
State/province [43]
0
0
Izmir
Query!
Country [44]
0
0
Ukraine
Query!
State/province [44]
0
0
Kharkiv
Query!
Country [45]
0
0
United Kingdom
Query!
State/province [45]
0
0
London, City Of
Query!
Country [46]
0
0
United Kingdom
Query!
State/province [46]
0
0
Birmingham
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Genzyme, a Sanofi Company
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
Primary 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 (MS). Secondary Objective: * To assess the effect of teriflunomide in comparison to placebo on disease activity/progression measured by brain magnetic resonance imaging (MRI) and on cognitive function. * To evaluate the safety and tolerability of teriflunomide in comparison to placebo. * To evaluate the pharmacokinetics (PK) of teriflunomide.
Query!
Trial website
https://clinicaltrials.gov/study/NCT02201108
Query!
Trial related presentations / publications
Chitnis T, Banwell B, Kappos L, Arnold DL, Gucuyener K, Deiva K, Skripchenko N, Cui LY, Saubadu S, Hu W, Benamor M, Le-Halpere A, Truffinet P, Tardieu M; TERIKIDS Investigators. Safety and efficacy of teriflunomide in paediatric multiple sclerosis (TERIKIDS): a multicentre, double-blind, phase 3, randomised, placebo-controlled trial. Lancet Neurol. 2021 Dec;20(12):1001-1011. doi: 10.1016/S1474-4422(21)00364-1.
Query!
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
Query!
Contacts
Principal investigator
Name
0
0
Clinical Sciences & Operations
Query!
Address
0
0
Sanofi
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
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
Query!
When will data be available (start and end dates)?
Query!
Available to whom?
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/08/NCT02201108/Prot_002.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/08/NCT02201108/SAP_003.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT02201108