Status:
COMPLETED
A Combination Trial of Copaxone Plus Estriol in Relapsing Remitting Multiple Sclerosis (RRMS)
Lead Sponsor:
University of California, Los Angeles
Collaborating Sponsors:
Washington University School of Medicine
University of Texas Southwestern Medical Center
Conditions:
Relapsing Remitting Multiple Sclerosis
Eligibility:
FEMALE
18-50 years
Phase:
PHASE2
Brief Summary
This is a double-blinded, placebo controlled study of estriol pills versus placebo pills in relapsing remitting multiple sclerosis. The study treatment will be an added on to Copaxone injections in al...
Detailed Description
Multiple sclerosis (MS) relapses are known to be significantly decreased during pregnancy. This proposal will establish whether oral treatment with estriol, the major estrogen of pregnancy, induces a ...
Eligibility Criteria
Inclusion
- Diagnosis of relapsing remitting multiple sclerosis
- At least one relapse in the last two years
Exclusion
- Patients treated in the past with total lymphoid irradiation, monoclonal antibody, T cell vaccination, cladribine, bone marrow transplantation, azathioprine, cyclophosphamide, methotrexate, mitoxantrone, cyclosporin or Tysabri
- Clinically significant diseases other than multiple sclerosis
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
158 Patients enrolled
Trial Details
Trial ID
NCT00451204
Start Date
March 1 2007
End Date
July 1 2014
Last Update
June 16 2016
Active Locations (16)
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1
Mayo Clinic
Scottsdale, Arizona, United States, 85259
2
University of California, Los Angeles
Los Angeles, California, United States, 90095
3
University of Colorado
Aurora, Colorado, United States, 80045
4
University of Chicago
Chicago, Illinois, United States, 60637