Phase III Study With Teriflunomide Versus Placebo in Patients With First Clinical Symptom of Multiple Sclerosis - Full Text View

Sponsor:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00622700

Purpose

The primary objective is to demonstrate the effect of teriflunomide (14 mg/day and 7 mg/day) compared to placebo for reducing conversion of patients presenting with their first clinical episode consistent with Multiple Sclerosis (MS) to clinically definite MS.

Condition	Intervention	Phase
Multiple Sclerosis	Drug: Teriflunomide (HMR1726) Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Control: Placebo Control Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Multiple Sclerosis

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Conversion to clinically definite MS [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Conversion to definite MS based on MRI data as defined by the demonstration of dissemination of MRI lesions in time [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Annualized relapse rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Burden of disease and other MRI variables [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Proportion of disability-free patients, reported fatigue and Quality of Life [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Safety and tolerability of teriflunomide [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	780
Study Start Date:	February 2008
Estimated Study Completion Date:	October 2012
Estimated Primary Completion Date:	October 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental dose 7 mg	Drug: Teriflunomide (HMR1726) oral administration once daily
2: Experimental dose 14 mg	Drug: Teriflunomide (HMR1726) oral administration once daily
3: Placebo Comparator	Drug: Placebo oral administration once daily

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with a first acute or subacute, well-defined neurological event consistent with demyelination (i.e. optic neuritis confirmed by an ophthalmologist, spinal cord syndrome, brainstem/cerebellar syndromes)
Onset of MS symptoms occurring within 60 days of randomization
A screening MRI scan with 2 or more T2 lesions at least 3 mm in diameter that are characteristic of MS

Exclusion Criteria:

Patients with clinically relevant cardiovascular, hepatic, neurological, endocrine or other major systemic disease
Patients with significantly impaired bone marrow function
Pregnant or nursing women
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 patient's potential participation in a clinical trial.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00622700

Contacts

Contact: For site information, send an email with site number to

GV-contact-us@sanofi-aventis.com

Show 144 Study Locations

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

ICD CSD

Sanofi-Aventis

More Information

No publications provided

Responsible Party:	sanofi-aventis ( ICD Study Director )
Study ID Numbers:	EFC6260, HMR1726D-3005, EudraCT 2006-001152-12
Study First Received:	February 14, 2008
Last Updated:	March 15, 2010
ClinicalTrials.gov Identifier:	NCT00622700 History of Changes
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada; France: Afssaps - French Health Products Safety Agency; Germany: Paul-Ehrlich-Institut

Keywords provided by Sanofi-Aventis:

MS
CIS
CDMS
relapses

Additional relevant MeSH terms:

Pathologic Processes
Autoimmune Diseases
Multiple Sclerosis
Immune System Diseases
Demyelinating Diseases

Nervous System Diseases
Demyelinating Autoimmune Diseases, CNS
Sclerosis
Autoimmune Diseases of the Nervous System

ClinicalTrials.gov processed this record on March 18, 2010