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Immunomodulator

Teriflunomide for Pediatric Multiple Sclerosis (TERIKIDS Trial)

Phase 3
Waitlist Available
Research Sponsored by Genzyme, a Sanofi Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, db period: weeks 24, 48, 72 and 96; ol period: weeks 24, 48, 72, 96, 120, 144, 168 and 192
Awards & highlights

TERIKIDS Trial Summary

This trial is testing whether the drug teriflunomide can help treat multiple sclerosis in children and adolescents. The trial will compare teriflunomide to a placebo, and will measure disease activity, brain MRI changes, and cognitive function.

Who is the study for?
This trial is for children and adolescents aged 10 to 17 with relapsing forms of multiple sclerosis (MS) who've had at least one MS attack in the past year or two in the last two years. They must not have severe disability from MS, haven't used certain MS drugs recently, can undergo MRI scans, and aren't pregnant.Check my eligibility
What is being tested?
The trial tests Teriflunomide against a placebo to see if it reduces the time until a child's next MS relapse. It also looks at how the drug affects brain lesions seen on MRI and cognitive function while checking its safety and how it's processed by young bodies.See study design
What are the potential side effects?
While specific side effects are not listed here, common ones associated with Teriflunomide include liver problems, hair thinning, nausea, diarrhea, numbness or tingling in hands or feet. The study will monitor these and other potential side effects.

TERIKIDS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, db period: weeks 24, 48, 72 and 96; ol period: weeks 24, 48, 72, 96, 120, 144, 168 and 192
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, db period: weeks 24, 48, 72 and 96; ol period: weeks 24, 48, 72, 96, 120, 144, 168 and 192 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time to First Confirmed Clinical Relapse
Secondary outcome measures
Brain Magnetic Resonance Imaging (MRI) Assessment: Number of New or Enlarged T2 Lesions Per MRI Scan
Brain Magnetic Resonance Imaging Assessment: Change From Baseline in Volume of T1 Hypointense Lesions
Brain Magnetic Resonance Imaging Assessment: Change From Baseline in Volume of T2 Lesions at Weeks 24, 36, 48, 72, 96, 144 and 192
+18 more

Side effects data

From 2015 Phase 4 trial • 1001 Patients • NCT01895335
23%
Alopecia
17%
Diarrhoea
8%
Nausea
7%
Headache
6%
Urinary Tract Infection
6%
Alanine Aminotransferase Increased
5%
Fatigue
5%
Nasopharyngitis
2%
Multiple Sclerosis Relapse
1%
Hypertension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Teriflunomide

TERIKIDS Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: TeriflunomideExperimental Treatment1 Intervention
Teriflunomide oral tablet, three dosages (3.5, 7 or 14 mg) to reach 14 mg adult equivalent
Group II: PlaceboPlacebo Group1 Intervention
Matching placebo tablets
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Teriflunomide
2008
Completed Phase 4
~6190

Find a Location

Who is running the clinical trial?

Genzyme, a Sanofi CompanyLead Sponsor
524 Previous Clinical Trials
85,476 Total Patients Enrolled
34 Trials studying Multiple Sclerosis
6,405 Patients Enrolled for Multiple Sclerosis
Clinical Sciences & OperationsStudy DirectorSanofi
857 Previous Clinical Trials
2,018,789 Total Patients Enrolled
36 Trials studying Multiple Sclerosis
11,425 Patients Enrolled for Multiple Sclerosis

Media Library

Teriflunomide (Immunomodulator) Clinical Trial Eligibility Overview. Trial Name: NCT02201108 — Phase 3
Multiple Sclerosis Research Study Groups: Placebo, Teriflunomide
Multiple Sclerosis Clinical Trial 2023: Teriflunomide Highlights & Side Effects. Trial Name: NCT02201108 — Phase 3
Teriflunomide (Immunomodulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02201108 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Have medical researchers conducted this type of trial before?

"Genzyme, a subsidiary of Sanofi, first researched Teriflunomide in 2014. After the Phase 1 study concluded that year with 166 participants, the drug was approved for further testing in Phase 3 trials. As of now, there are 13 ongoing studies involving Teriflunomide across 323 cities and 62 countries."

Answered by AI

Could you tell me how many research facilities are currently conducting this trial?

"There are 10 sites conducting this clinical trial currently. A few locations include Calgary, Cullman and Boston with other centres located throughout. If you are considering participating in the study, please choose the clinic that is closest to your residence to minimize travel time and effort."

Answered by AI

Has Teriflunomide been given the green light by the FDA?

"Teriflunomide has been studied in prior clinical trials and shown to be safe, so it received a score of 3."

Answered by AI

How can I become a part of this experiment?

"This clinical trial, which will enroll 166 patients, is for children and adolescents between the ages of 10-17 who have multiple sclerosis."

Answered by AI

Are patients still being enrolled in this research project?

"Unfortunately, this specific study is not presently looking for candidates according to the clinicaltrials.gov website. Although 576 other trials are actively recruiting patients right now, this particular trial was last updated on June 15th, 2022 and is no longer seeking participants."

Answered by AI

How many study participants are receiving treatment?

"Unfortunately, this study is not currently recruiting new participants. Having said that, it's worth noting that the date of the last edit was June 15th, 2022. There are 563 other trials for multiple sclerosis and 13 for Teriflunomide enrolling patients as we speak."

Answered by AI

Are adults of age eligible for this research project?

"This clinical trial is looking for paediatric patients that are between 10 to 17 years old."

Answered by AI

Are there other studies that have looked at Teriflunomide's effects?

"Teriflunomide was first evaluated in 2014 at Site 056001. Since then, there have been a total of 18314 completed studies investigating this medication. As of now, there are 13 active clinical trials underway. A large majority of these are located in Calgary, Alabama."

Answered by AI
~16 spots leftby Mar 2025