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NCT02201108 · ClinicalTrials.gov registry record · Phase 3
Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients With Relapsing Forms of Multiple Sclerosis
A Phase 3 study, sponsored by Genzyme, a Sanofi Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 166
- Enrollment target
NCT02201108: Completed Phase 3 study, sponsored by Genzyme, a Sanofi Company.
NCT02201108 is a Phase 3 study that has completed, run by Genzyme, a Sanofi Company. The registered enrollment target is 166 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02201108, a Phase 3 study, has completed, sponsored by Genzyme, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 166 participants
- Enrollment target
Study 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.
Primary Outcome
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: brai
Interventions
- DRUG Placebo
- DRUG Teriflunomide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 166 participants |
| Start Date | 2014-07-16 |
| Est. Completion | 2024-07-29 |
| Phase | Phase 3 |
What the finished NCT02201108 record still lists
NCT02201108 is an interventional study that assigns participants to a tested intervention. The registered 166 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02201108 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02201108 about?
NCT02201108 is a clinical study titled "Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients With Relapsing Forms of Multiple Sclerosis". 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 ...
What is the current status of trial NCT02201108?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 166 participants. The study started on 2014-07-16. Estimated completion is 2024-07-29.
What interventions are being tested in trial NCT02201108?
The interventions under investigation include: Placebo (DRUG), Teriflunomide (DRUG).
Who is sponsoring clinical trial NCT02201108?
This trial is sponsored by Genzyme, a Sanofi Company, which has 196 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02201108's enrollment target sits among peer trials
166 1463rd of 2000 higher than 536 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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