A Combination Trial of Copaxone Plus Estriol in Relapsing Remitting Multiple Sclerosis (RRMS)

Completed · Phase 2 · Has a placebo group

Conditions studied: Relapsing Remitting Multiple Sclerosis

In brief

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 all subjects. The primary outcome measure is a reduction in relapses.

Key facts

Study ID

NCT00451204

Run by

University of California, Los Angeles

People needed

158

Starts

2007-03-01

Expected to finish

2014-07-01

Last updated by the study team

2016-06-16

Who can join

Age: 18 and older, up to 50. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of relapsing remitting multiple sclerosis
• At least one relapse in the last two years

You may not qualify if…

• 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

Where it is running

• Mayo Clinic — Scottsdale, Arizona, United States
• University of California, Los Angeles — Los Angeles, California, United States
• University of Colorado — Aurora, Colorado, United States
• University of Chicago — Chicago, Illinois, United States
• University of Kansas — Kansas City, Kansas, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Washington University — St Louis, Missouri, United States
• Dartmouth Medical School — Lebanon, New Hampshire, United States
• UMDNJ-Robert Wood Johnson Medical Center — New Brunswick, New Jersey, United States
• University of New Mexico — Albuquerque, New Mexico, United States
• Ohio State University — Columbus, Ohio, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• University of Texas Southwestern — Dallas, Texas, United States
• Western Institute for Biomedical Research — Salt Lake City, Utah, United States
• Montreal Neurological Institute — Montreal, Canada

Full record on ClinicalTrials.gov

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