Phase III Study With Teriflunomide Versus Placebo in Patients With First Clinical Symptom of Multiple Sclerosis
Public ClinicalTrials.gov record NCT00622700. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
An International, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Two Year Treatment With Teriflunomide 7 mg Once Daily and 14 mg Once Daily Versus Placebo in Patients With a First Clinical Episode Suggestive of Multiple Sclerosis Plus a Long Term Extension Period
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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
Study identification
- NCT ID
- NCT00622700
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 618 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 55 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 2008 (Type not available)
- Primary completion
- Dec 2012 (Actual)
- Completion
- Feb 2016 (Actual)
- Last update posted
- Mar 13, 2017
2008 – 2016
United States locations
- U.S. sites
- 19
- U.S. states
- 15
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Investigational Site Number 8965 | Cullman | Alabama | 35058 | — |
| Investigational Site Number 8954 | Phoenix | Arizona | 85013-4496 | — |
| Investigational Site Number 8946 | Phoenix | Arizona | 85060 | — |
| Investigational Site Number 8962 | Fort Collins | Colorado | 80528 | — |
| Investigational Site Number 8920 | Maitland | Florida | 32761 | — |
| Investigational Site Number 8953 | St. Petersburg | Florida | 33701 | — |
| Investigational Site Number 8914 | Fort Wayne | Indiana | 63104 | — |
| Investigational Site Number 8940 | Indianapolis | Indiana | 46256 | — |
| Investigational Site Number 8922 | Shreveport | Louisiana | 71103 | — |
| Investigational Site Number 8955 | Grand Rapids | Michigan | 49503 | — |
| Investigational Site Number 8949 | Traverse City | Michigan | 49684 | — |
| Investigational Site Number 8937 | St Louis | Missouri | 63104 | — |
| Investigational Site Number 8951 | Albuquerque | New Mexico | 87131 | — |
| Investigational Site Number 8925 | New York | New York | 10029-6574 | — |
| Investigational Site Number 8941 | Charlotte | North Carolina | 28204 | — |
| Investigational Site Number 8924 | Dayton | Ohio | 45409 | — |
| Investigational Site Number 8905 | Round Rock | Tennessee | 78681 | — |
| Investigational Site Number 8930 | Burlington | Vermont | 05401 | — |
| Investigational Site Number 8963 | Seattle | Washington | 98122 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 112 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00622700, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 13, 2017 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00622700 live on ClinicalTrials.gov.