Status:
COMPLETED
Phase III Study With Teriflunomide Versus Placebo in Patients With First Clinical Symptom of Multiple Sclerosis
Lead Sponsor:
Sanofi
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-55 years
Phase:
PHASE3
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 present...
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), * ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2016
Estimated Enrollment :
618 Patients enrolled
Trial Details
Trial ID
NCT00622700
Start Date
February 1 2008
End Date
February 1 2016
Last Update
March 13 2017
Active Locations (131)
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1
Investigational Site Number 8965
Cullman, Alabama, United States, 35058
2
Investigational Site Number 8954
Phoenix, Arizona, United States, 85013-4496
3
Investigational Site Number 8946
Phoenix, Arizona, United States, 85060
4
Investigational Site Number 8962
Fort Collins, Colorado, United States, 80528