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

• Register: ClinicalTrials.gov
• Last refreshed on: 11 September 2023
• Main ID: NCT02201108
• Date of registration: 17/07/2014
• Prospective Registration: No
• Primary sponsor: Genzyme, a Sanofi Company
• Public title: Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients With Relapsing Forms of Multiple Sclerosis TERIKIDS
• 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
• Date of first enrolment: July 16, 2014
• Target sample size: 166
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT02201108
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Australia, Belgium, Bulgaria, Canada, China, Estonia, France, Greece, Israel, Lebanon, Lithuania, Macedonia, The Former Yugoslav Republic of, Morocco, Netherlands, North Macedonia, Poland, Portugal, Russian Federation, Serbia, Slovenia, Spain, Tunisia, Turkey, Ukraine, United Kingdom, United States

Contacts

• Name: Clinical Sciences & Operations
• Affiliation: Sanofi

Key inclusion & exclusion 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.

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.



Age minimum: 10 Years
Age maximum: 17 Years
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Drug: Placebo

Drug: Teriflunomide

Primary Outcome(s)

Time to First Confirmed Clinical Relapse [Time Frame: Baseline up to Week 96]

Secondary Outcome(s)

Brain Magnetic Resonance Imaging (MRI) Assessment: Number of New or Enlarged T2 Lesions Per MRI Scan [Time Frame: Baseline up to Week 192]

Brain Magnetic Resonance Imaging Assessment: Number of T1 Gadolinium (Gd)-Enhancing T1 Lesions Per MRI Scan [Time Frame: Baseline up to Week 192]

Brain Magnetic Resonance Imaging Assessment: Percent Change From Baseline in Brain Volume at Weeks 24, 36, 48, 72, 96, 144 and 192 [Time Frame: Baseline, DB period: Weeks 24, 36, 48, 72 and 96; OL period: Weeks 48, 96, 144 and 192]

Cognitive Assessment - Selective Reminding Test (SRT): Change From Baseline in Total Number of Words on Delayed Recall at Weeks 96 and 192 [Time Frame: Baseline, Weeks 96 and 192]

Cognitive Assessment: Change From Baseline in Brief Visuospatial Memory Test-Revised (BVMT-R) Scores at Weeks 96 and 192 [Time Frame: Baseline, Weeks 96 and 192]

Cognitive Assessment: Change From Baseline in Wechsler Abbreviated Scale of Intelligence-II (WASI-II) Vocabulary Total Raw Scores at Weeks 96 and 192 [Time Frame: Baseline, Weeks 96 and 192]

Brain Magnetic Resonance Imaging Assessment: Number of New T1 Hypointense Lesions Per MRI Scan [Time Frame: Baseline up to Week 192]

Brain Magnetic Resonance Imaging Assessment: Percentage of Participants Free of New or Enlarged MRI T2-Lesions [Time Frame: Baseline, Weeks 24, 48, 72, 96, 144 and 192]

Cognitive Assessment: Change From Baseline in Beery Visual-motor Integration (BVMI) Scores at Weeks 96 and 192 [Time Frame: Baseline, Weeks 96 and 192]

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 [Time Frame: Baseline, DB period: Weeks 24, 48, 72 and 96; OL period: Weeks 24, 48, 72, 96, 120, 144, 168 and 192]

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 [Time Frame: Baseline, DB period: Weeks 24, 48, 72 and 96; OL period: Weeks 24, 48, 72, 96, 120, 144, 168 and 192]

OL: Time to First Confirmed Clinical Relapse [Time Frame: Baseline up to Week 192]

Brain Magnetic Resonance Imaging Assessment: Change From Baseline in Volume of T2 Lesions at Weeks 24, 36, 48, 72, 96, 144 and 192 [Time Frame: Baseline, DB period: Weeks 24, 36, 48, 72 and 96; OL period: Weeks 48, 96, 144 and 192]

Cognitive Assessment: Change From Baseline in Delis-Kaplan Executive Function System Category Fluency Total Correct Raw Score at Weeks 96 and 192 [Time Frame: Baseline, Weeks 96 and 192]

Cognitive Assessment: Change From Baseline in Trail Making Test B (TMT-B) Test Scores (in Seconds) at Weeks 96 and 192 [Time Frame: Baseline, Weeks 96 and 192]

Brain Magnetic Resonance Imaging Assessment: Change From Baseline in Volume of T1 Hypointense Lesions [Time Frame: Baseline, DB period: Weeks 24, 36, 48, 72 and 96; OL period: Weeks 48, 96, 144 and 192]

Cognitive Assessment: Change From Baseline in Trail Making Test- Part A (TMT-A) Test Scores (in Seconds) at Week 96 and 192 [Time Frame: Baseline, Weeks 96 and 192]

DB: Pharmacokinetics: Steady-state Trough Concentration (Ctrough) of Teriflunomide [Time Frame: Predose on Week 36]

Cognitive Assessment: Change From Baseline in Delis-Kaplan Executive Function System (D-KEFS) Letter Fluency Total Correct Raw Score at Weeks 96 and 192 [Time Frame: Baseline, Weeks 96 and 192]

OL: Pharmacokinetics: Steady-state Trough Concentration (Ctrough) of Teriflunomide [Time Frame: Pre-dose at Week 36]

Probability of Participants Who Were Clinical Relapse Free at Weeks 24, 48, 72, 96, 120, 144, 168 and 192 [Time Frame: Weeks 24, 48, 72, 96, 120, 144, 168 and 192]

Secondary ID(s)

U1111-1124-0983

2011-005249-12

EFC11759

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 30/11/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02201108