Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00134563
Status:
COMPLETED
Last Update Posted:
2013-01-04
First Post:
2005-08-23
Brief Title:
Study of Teriflunomide in Reducing the Frequency of Relapses and Accumulation of Disability in Patients With Multiple Sclerosis
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Parallel Group Design Study to Evaluate the Efficacy and Safety of Teriflunomide in Reducing the Frequency of Relapses and Delaying the Accumulation of Physical Disability in Subjects With Multiple Sclerosis With Relapses
Status:
COMPLETED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TEMSO
Brief 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
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
Detailed Description:
The study period per participant was approximatively 128 weeks broken down as follows
Screening period up to 4 weeks
108-week double-blind treatment period approximatively 2 years
16-week post-treatment elimination follow-up period
Participants successfully completing the week 108 visit were offered the opportunity to enter the optional long-term extension study LTS6050 - NCT00803049
Screening period up to 4 weeks
108-week double-blind treatment period approximatively 2 years
16-week post-treatment elimination follow-up period
Participants successfully completing the week 108 visit were offered the opportunity to enter the optional long-term extension study LTS6050 - NCT00803049
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HMR1726D3001 | OTHER | HMR | None |
| 2004-000555-42 | EUDRACT_NUMBER | None | None |