| February 14, 2008 |
| October 19, 2009 |
| February 2008 |
| October 2012 (final data collection date for primary outcome measure) |
| Conversion to clinically definite MS [ Time Frame: 2 years ] [ Designated as safety issue: No ] |
| Conversion to clinically definite MS [ Time Frame: up to 2 years ] |
| Complete list of historical versions of study NCT00622700 on ClinicalTrials.gov Archive Site |
- 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 ]
|
- Conversion to definite MS based on MRI data as defined by the demonstration of dissemination of MRI lesions in time
- Annualized relapse rate
- Burden of disease and other MRI variables
- Proportion of disability-free patients, reported fatigue and Quality of Life
- Safety and tolerability of teriflunomide
|
| |
| Phase III Study With Teriflunomide Versus Placebo in Patients With First Clinical Symptom of Multiple Sclerosis |
| 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 |
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. |
| |
| Phase III |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
| Multiple Sclerosis |
- Drug: Teriflunomide (HMR1726)
- Drug: Placebo
|
- Experimental: dose 7 mg
- Experimental: dose 14 mg
|
| |
| |
| Recruiting |
| 780 |
| October 2012 |
| October 2012 (final data collection date for primary outcome measure) |
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. |
| Both |
| 18 Years to 55 Years |
| No |
|
|
| United States, Australia, Austria, Bulgaria, Canada, Chile, Czech Republic, Denmark, Estonia, Finland, France, Germany, Hungary, Mexico, Poland, Romania, Slovakia, Turkey, Ukraine, United Kingdom |
| |
| NCT00622700 |
| ICD Study Director, sanofi-aventis |
| EFC6260, HMR1726D-3005, EudraCT 2006-001152-12 |
| Sanofi-Aventis |
|
| Study Director: |
ICD CSD |
Sanofi-Aventis |
|
|
| Sanofi-Aventis |
| October 2009 |
