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NCT00622700 · ClinicalTrials.gov registry record · Phase 3
Phase III Study With Teriflunomide Versus Placebo in Patients With First Clinical Symptom of Multiple Sclerosis
A Phase 3 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 618
- Enrollment target
NCT00622700: Completed Phase 3 study, sponsored by Sanofi.
NCT00622700 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 618 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (20% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00622700, a Phase 3 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 618 participants
- Enrollment target
Study Summary
The primary objective was to demonstrate the effect of teriflunomide (HMR1726) (14 milligram per day \[mg/day\] and 7 mg/day), in comparison to placebo, for reducing conversion of participants presenting with their first clinical episode consistent with multiple sclerosis (MS) to clinically definite multiple sclerosis (CDMS). The secondary objectives were: * To demonstrate the effect of teriflunomide, in comparison to placebo, on: * Reducing conversion to definite multiple sclerosis (DMS) * Reducing annualized relapse rate (ARR) * Reducing disease activity/progression as measured by Magnetic Resonance Imaging (MRI) * Reducing accumulation of disability for at least 12 weeks as measured by the Expanded Disability Status Scale (EDSS) * Proportion of disability-free participants as assessed by the EDSS * Reducing participant-reported fatigue * To evaluate the safety and tolerability of teriflunomide * To evaluate the pharmacokinetics (PK) of teriflunomide * Optional pharmacogenomic testing aimed at assessing the association between the main enzyme systems of teriflunomide metabolism and hepatic safety, and other potential associations between gene variations and clinical outcomes
Primary Outcome
Conversion to CDMS was defined by the occurrence of a relapse, which was defined as a new neurological abnormality separated by at least 30 days from onset of a preceding clinical event, presented for at least 24 hours and occurred in the absence of fever or known infection. Percent probability of conversion at 24, 48, and 108 weeks was estimated using Kaplan-Meier method.
Interventions
- DRUG Placebo
- DRUG Teriflunomide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 618 participants |
| Start Date | 2008-02 |
| Est. Completion | 2016-02 |
| Phase | Phase 3 |
What the finished NCT00622700 record still lists
NCT00622700 is an interventional study that assigns participants to a tested intervention. The registered 618 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 (20% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00622700 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00622700 about?
NCT00622700 is a clinical study titled "Phase III Study With Teriflunomide Versus Placebo in Patients With First Clinical Symptom of Multiple Sclerosis". The primary objective was to demonstrate the effect of teriflunomide (HMR1726) (14 milligram per day \[mg/day\] and 7 mg/day), in comparison to placebo, for reducing conversion of participants presenting with their first clinical episode consistent with multiple sclerosis (MS) to clinically definite...
What is the current status of trial NCT00622700?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 618 participants. The study started on 2008-02. Estimated completion is 2016-02.
What interventions are being tested in trial NCT00622700?
The interventions under investigation include: Placebo (DRUG), Teriflunomide (DRUG).
Who is sponsoring clinical trial NCT00622700?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00622700's enrollment target sits among peer trials
618 591st of 2000 higher than 1,409 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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