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Status:

COMPLETED

Long Term Safety and Efficacy of Teriflunomide (HMR1726) in Multiple Sclerosis With Relapses

Lead Sponsor:

Sanofi

Conditions:

Multiple Sclerosis

Eligibility:

All Genders

18-65 years

Phase:

PHASE2

Brief Summary

The primary objective is to assess the long-term safety of teriflunomide in multiple sclerosis subjects. The secondary objective is to assess the long-term efficacy.

Detailed Description

Subjects completing the HMR 1726D/2001 study are given the opportunity to continue or switch to teriflunomide for 528 weeks or until teriflunomide is commercially available in the country where patien...

Eligibility Criteria

Inclusion

  • Satisfactorily completion of HMR1726D/2001 study with respect to safety.
  • If female subject, non-childbearing potential or child bearing potential with adequate contraception.
  • Consent to practice/maintain adequate means of contraception throughout the study and for 24 months after the discontinuation of treatment.
  • Clinically definite Multiple Sclerosis (MS) as established on entry into HMR1726D/2001 study.
  • Extended Disability Status Score(EDSS) between 0 and 6 inclusively, when the subject entered HMR1726D/2001 study.
  • Magnetic Resonance Imaging (MRI) criteria must continue to support the diagnosis of clinically definite MS.
  • Willingness to participate in a long-term safety and efficacy trial.

Exclusion

  • Subject who did not complete HMR 1726D/2001 study for safety reasons.
  • Subject who developed clinically relevant cardiovascular, hepatic, endocrine or other major disease.
  • Pregnancy.
  • Breast-feeding.
  • Wish to parent.
  • Likelihood of requiring treatment during the study period with drugs not permitted.
  • Disallowed therapies such asw immunomodulators, immunosuppressants.
  • Recent history of drug or alcohol abuse.
  • Liver function impairment.
  • Abnormal mental conditions.

Key Trial Info

Start Date :

January 1 2002

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 1 2015

Estimated Enrollment :

147 Patients enrolled

Trial Details

Trial ID

NCT00228163

Start Date

January 1 2002

End Date

January 1 2015

Last Update

March 25 2015

Active Locations (16)

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Page 1 of 4 (16 locations)

1

Investigational Site Number 16

Calgary, Canada, T2N 2T9

2

Investigational Site Number 10

Halifax, Canada, B3H 1V7

3

Investigational Site Number 15

London, Canada, N6A 5A5

4

Investigational Site Number 12

Montreal, Canada, H2L 4M1