Overview

This trial is active, not recruiting.

Condition multiple sclerosis
Treatments teriflunomide, placebo
Phase phase 3
Sponsor Sanofi
Start date February 2008
End date December 2012
Trial size 618 participants
Trial identifier NCT00622700, 2006-001152-12, EFC6260, HMR1726D-3005

Summary

The primary objective is 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 are:

- 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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Placebo Comparator)
Placebo matched to teriflunomide tablet once daily orally.
placebo
Film-coated tablet Oral administration
(Experimental)
Teriflunomide 7 mg tablet once daily orally.
teriflunomide HMR1726
Film-coated tablet Oral administration
(Experimental)
Teriflunomide 14 mg tablet once daily orally.
teriflunomide HMR1726
Film-coated tablet Oral administration

Primary Outcomes

Measure
Time to Conversion to Clinically Definite Multiple Sclerosis (CDMS)
time frame: Up to a maximum of 108 weeks depending on time of enrollment

Secondary Outcomes

Measure
Time to Conversion to Definite Multiple Sclerosis (DMS)
time frame: Up to a maximum of 108 weeks depending on time of enrollment
Annualized Relapse Rate (ARR)
time frame: Up to a maximum of 108 weeks depending on time of enrollment
Brain Magnetic Resonance Imaging (MRI) Assessment: Change From Baseline in Total Lesion Volume at Week 108
time frame: Baseline, Week 108
Brain MRI Assessment: Number of Gadolinium Enhancing (Gd-enhancing) T1-lesions Per MRI Scan (Poisson Regression Estimates)
time frame: Up to a maximum of 108 weeks depending on time of enrollment
Brain MRI Assessment: Volume of Gadolinium Enhancing (Gd-enhancing) T1-lesions Per MRI Scan
time frame: Up to a maximum of 108 weeks depending on time of enrollment
Brain MRI Assessment: Change From Baseline in Volume of Hypointense Post-Gadolinium T1 Lesion Component
time frame: Baseline, Week 108
Brain MRI Assessment: Change From Baseline in Volume of T2 Lesion Component
time frame: Baseline, Week 108
Brain MRI Assessment: Percent Change From Baseline in Atrophy
time frame: Baseline, Week 108
Time to 12-Week Sustained Disability Progression
time frame: Up to a maximum of 108 weeks depending on time of enrollment
Change From Baseline in EDSS at Week 108
time frame: Baseline, Week 108
Change From Baseline in Fatigue Impact Scale (FIS) Total Score at Week 108
time frame: Baseline, Week 108
Overview of Adverse Events (AEs)
time frame: From first study drug intake up to 112 days after last intake in the placebo-controlled period or up to first intake in the extension treatment period, whichever occurred first

Eligibility Criteria

Male or female participants from 18 years up to 55 years old.

Inclusion Criteria: - First acute or subacute, well-defined neurological event consistent with demyelination (that is, optic neuritis confirmed by an ophthalmologist, spinal cord syndrome, brainstem/cerebellar syndromes) - Onset of MS symptoms occurring within 90 days of randomization - A screening MRI scan with 2 or more T2 lesions at least 3 millimeter (mm) in diameter that are characteristic of MS Exclusion Criteria: - Clinically relevant cardiovascular, hepatic, neurological, endocrine or other major systemic disease - Significantly impaired bone marrow function - Pregnancy or nursing - Alcohol or drug abuse - Use of cladribine, mitoxantrone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate or mycophenolate before enrollment - Any known condition or circumstance that would prevent in the investigator's opinion compliance or completion of the study The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Additional 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
Description The study consists 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 will continue until teriflunomide is 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 is expected to be 116 weeks if he/she does not continue in the extension treatment period.
Trial information was received from ClinicalTrials.gov and was last updated in December 2014.
Information provided to ClinicalTrials.gov by Sanofi.