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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00751881 |
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Date of registration:
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07/05/2008 |
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Primary sponsor: |
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Public title:
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An Efficacy Study of Teriflunomide in Patients With Relapsing Multiple Sclerosis
TOWER |
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Scientific title:
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A Multi-center Double-blind Parallel-group Placebo-controlled Study of the Efficacy and Safety of Teriflunomide in Patients With Relapsing Multiple Sclerosis |
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Date of first enrolment:
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August 2008 |
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Target sample size:
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1110 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00751881 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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Countries of recruitment
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Australia
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Austria
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Belarus
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Belgium
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Canada
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Chile
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China
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Czech Republic
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Estonia
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France
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Germany
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Greece
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Mexico
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Netherlands
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Philippines
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Poland
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Romania
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Slovakia
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South Africa
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Spain
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Sweden
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Thailand
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Tunisia
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Turkey
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Ukraine
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United Kingdom
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United States
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Contacts
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Name:
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Clinical Sciences & Operations |
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Address:
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Telephone:
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Email:
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Affiliation:
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Sanofi-Aventis |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Relapsing multiple sclerosis,
- Two relapses in prior 2 years or one relapse in prior year.
Exclusion Criteria:
- Clinically relevant cardiovascular, hepatic, neurological, endocrine or other major
systemic disease,
- 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.
- Human immunodeficiency virus (HIV) positive,
- 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.
Age minimum:
18 Years
Age maximum:
55 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Multiple Sclerosis
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Intervention(s)
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Drug: Placebo
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Drug: Teriflunomide (HMR1726)
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Primary Outcome(s)
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Annualized relapse rate (number of relapses per patient-year)
[Time Frame: Average of 2 years (between 1 and 3 years)]
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Secondary Outcome(s)
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Change from baseline in Short Form generic health survey [36 items] (SF-36) scale
[Time Frame: 48 weeks]
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Change from baseline in subject reported fatigue as assessed by the Fatigue Impact Scale (FIS)
[Time Frame: 48 weeks]
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Time to disability progression as assessed by the Kurtzke Expanded Disability Status Scale (EDSS)
[Time Frame: Average of 2 years (between 1 and 3 years)]
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Secondary ID(s)
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EFC10531
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EudraCT : 2007-004452-36
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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