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

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.

Conditions

• Relapsing Remitting Multiple Sclerosis

Interventions

DRUG

Estriol

Estriol 8 mg capsule, once per day, duration of treatment is 2 years

DRUG

Placebo

Placebo capsule, once a day, treatment duration is 2 years

DRUG

Copaxone

Injection, once a day, all subjects

Sponsors & Collaborators

• Washington University School of Medicine

  collaborator OTHER

• University of Texas Southwestern Medical Center

  collaborator OTHER

• Ohio State University

  collaborator OTHER

• University of Medicine and Dentistry of New Jersey

  collaborator OTHER

• University of Chicago

  collaborator OTHER

• University of Utah

  collaborator OTHER

• Johns Hopkins University

  collaborator OTHER

• University of Kansas Medical Center

  collaborator OTHER

• University of Minnesota

  collaborator OTHER

• Mayo Clinic

  collaborator OTHER

• University of Colorado, Denver

  collaborator OTHER

• University of New Mexico

  collaborator OTHER

• University of Pennsylvania

  collaborator OTHER

• Dartmouth-Hitchcock Medical Center

  collaborator OTHER

• National Multiple Sclerosis Society

  collaborator OTHER

• National Institutes of Health (NIH)

  collaborator NIH

• National Institute of Neurological Disorders and Stroke (NINDS)

  collaborator NIH

• University of California, Los Angeles

  lead OTHER

Principal Investigators

• Rhonda Voskuhl, M.D. · University of California, Los Angeles (UCLA), Los Angeles, CA

• Anne Cross, M.D. · Washington University, Saint Louis, MO

• Elliot Frohman, M.D. · University of Texas, Southwestern, Dallas, TX

• Suhayl Dhib-Jalbut, M.D. · Robert Wood Johnson Medical School, UMDNJ, New Brunswick, NJ

• Michael Racke, M.D. · Ohio State University

• Anthony Reder, M.D. · University of Chicago

• John Rose, M.D. · Western Institute for Biomedical Research, Salt Lake City, UT

• Barbara Giesser, M.D. · University of California, Los Angeles (UCLA), Los Angeles, CA

• John Ratchford, M.D. · Johns Hopkins, Baltimore, MD

• Sharon Lynch, M.D. · University of Kansas

• Gareth Parry, M.D. · University of Minnesota

• Dean Wingerchuk, M.D. · Mayo Clinic

• John Corboy, M.D. · University of Colorado, Denver

• Corey Ford, M.D. · University of New Mexico, Albuquerque

• Dina Jacobs, M.D. · University of Pennsylvania

• Lloyd Kasper, M.D. · Dartmouth University, Lebanon, NH

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-03-31

Primary Completion

2014-07-31

Completion

2014-07-31

Countries

• United States
• Canada

Study Locations