Ignite Creation Date:
2025-12-26 @ 12:15 PM
Ignite Modification Date:
2025-12-31 @ 8:15 PM
Study NCT ID:
NCT00622700
Status:
COMPLETED
Last Update Posted:
2017-03-13
First Post:
2008-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phase III Study With Teriflunomide Versus Placebo in Patients With First Clinical Symptom of Multiple Sclerosis
Sponsor:
Sanofi
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2017-01
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:
TOPIC
Brief 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
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
Detailed Description:
The study consisted of 4 periods:
* Screening period: up to 4 weeks,
* Placebo-controlled treatment period: up to 108 weeks (at least 24 weeks for participants who experienced conversion to CDMS),
* Extension treatment period (without placebo-control): the extension period continued until teriflunomide was commercially available in participant's country of residence.
* Post-treatment washout period: 4 weeks after last treatment intake.
The maximal duration of the study period per participant was expected to be 116 weeks if he/she did not continue in the extension treatment period.
* Screening period: up to 4 weeks,
* Placebo-controlled treatment period: up to 108 weeks (at least 24 weeks for participants who experienced conversion to CDMS),
* Extension treatment period (without placebo-control): the extension period continued until teriflunomide was commercially available in participant's country of residence.
* Post-treatment washout period: 4 weeks after last treatment intake.
The maximal duration of the study period per participant was expected to be 116 weeks if he/she did not continue in the extension treatment period.
Study Oversight
Has Oversight DMC:
True
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?: