Phase III Study With Teriflunomide Versus Placebo in Patients With First Clinical Symptom of Multiple Sclerosis

Status:	Completed
Conditions:	Neurology, Multiple Sclerosis
Therapuetic Areas:	Neurology, Other
Healthy:	No
Age Range:	18 - 55
Updated:	4/21/2016
Start Date:	February 2008
End Date:	February 2016

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

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

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.

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.

We found this trial at

sites

Clinical Trial Facility in Fort Collins Colorado

Fort Collins, Colorado 80528

from

Fort Collins, CO