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

• Status: Completed
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: Female

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, Los Angeles
• Collaborators: Dartmouth-Hitchcock Medical Center; Johns Hopkins University; Mayo Clinic; National Institute of Neurological Disorders and Stroke (NINDS); National Institutes of Health (NIH); National Multiple Sclerosis Society; Ohio State University; University of Chicago; University of Colorado, Aurora; University of Colorado, Denver; University of Kansas Medical Center; University of Medicine and Dentistry of New Jersey; University of Minnesota; University of Minnesota, MN; University of New Mexico; University of Pennsylvania; University of Texas Southwestern Medical Center; University of Utah; Washington University School of Medicine
• Treatments: (T,G)-A-L; Estrogens; Glatiramer Acetate

Criteria

Inclusion Criteria:

• Diagnosis of relapsing remitting multiple sclerosis

• At least one relapse in the last two years

Exclusion Criteria:

• 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