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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 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 618 participants.
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
Interventions
- DRUG Placebo
- DRUG Teriflunomide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 618 participants |
| Start Date | 2008-02 |
| Est. Completion | 2016-02 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00622700
The ClinicalTrials.gov registry entry for NCT00622700 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 618 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00622700 reports 0 study locations.
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.
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