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NCT00134563 · ClinicalTrials.gov registry record · Phase 3

Study of Teriflunomide in Reducing the Frequency of Relapses and Accumulation of Disability in Patients With Multiple Sclerosis

A Phase 3 study, sponsored by Sanofi.

Completed
Registry status
Phase 3
Development phase
1,088
Enrollment target

NCT00134563 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 1,088 participants.

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The verdict

NCT00134563, a Phase 3 study, has completed, sponsored by Sanofi.

COMPLETED
Registry status
Phase 3
Development phase
1,088 participants
Enrollment target

Study Summary

The primary objective was to determine the effect of teriflunomide on the frequency of relapses in patients with relapsing multiple sclerosis (MS). Secondary objectives were: * to evaluate the effect of teriflunomide on the accumulation of disability as measured by Expanded Disability Status Scale \[EDSS\], the burden of disease as measured by Magnetic Resonance Imaging \[MRI\] and patient-reported fatigue; * to evaluate the safety and tolerability of teriflunomide.

Interventions

  • DRUG Teriflunomide
  • DRUG Placebo (for teriflunomide)

Trial Details

FieldValue
Enrollment Target 1,088 participants
Start Date 2004-09
Est. Completion 2010-07
Phase Phase 3

Sponsor

Sanofi

713 total trials

What the Registry Record Tells You About NCT00134563

The ClinicalTrials.gov registry entry for NCT00134563 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,088 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 Teriflunomide is the first listed.

NCT00134563 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00134563 about?

NCT00134563 is a clinical study titled "Study of Teriflunomide in Reducing the Frequency of Relapses and Accumulation of Disability in Patients With Multiple Sclerosis". The primary objective was to determine the effect of teriflunomide on the frequency of relapses in patients with relapsing multiple sclerosis (MS). Secondary objectives were: * to evaluate the effect of teriflunomide on the accumulation of disability as measured by Expanded Disability Status Scale...

What is the current status of trial NCT00134563?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,088 participants. The study started on 2004-09. Estimated completion is 2010-07.

What interventions are being tested in trial NCT00134563?

The interventions under investigation include: Teriflunomide (DRUG), Placebo (for teriflunomide) (DRUG).

Who is sponsoring clinical trial NCT00134563?

This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.