Status:
UNKNOWN
Safety and Tolerability of Interferon-Beta-1a and Estroprogestins Association in MS Patients
Lead Sponsor:
S. Andrea Hospital
Conditions:
Multiple Sclerosis
Eligibility:
FEMALE
18-40 years
Phase:
PHASE2
Brief Summary
Clinical and experimental evidences suggests an immunomodulatory effect of sex hormones in multiple sclerosis. The role of oral estroprogestins in the pathogenesis and in the clinical course of the d...
Detailed Description
Phase 2, randomised, single blind, three arms study. Follow-up of 24 months. The study will include relapsing-remitting multiple sclerosis female patients. Patients will be equally randomised into ...
Eligibility Criteria
Inclusion
- Female patients
- Clinically definite relapsing-remitting MS according to the McDonald criteria
- Age between 18-40 y.o.
- EDSS from 0 to 4.0, inclusive
Exclusion
- History of migraine or thromboembolic events
- Reproductive system disorders
- Pregnancy or suspension of pregnancy within 12 months prior to randomisation
- Prior use of estroprogestins within the last 3 months prior to randomisation
- Prior use of immunosuppressive drugs within the last 12 months prior to randomisation
- Prior use of immunomodulating drugs within the last 6 months prior to randomisation
- Prior use of corticosteroids within the last 3 months prior to randomisation
- Have clinical relapse 30 days prior to randomisation
Key Trial Info
Start Date :
May 1 2002
Trial Type :
INTERVENTIONAL
End Date :
December 1 2008
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00151801
Start Date
May 1 2002
End Date
December 1 2008
Last Update
September 9 2005
Active Locations (1)
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1
Department of Neurology - University of Rome La Sapienza
Rome, Rome, Italy, 00100