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MS Trial Alert: Clinical Trial of Sex Hormone Estriol Recruiting Women with MS to Participate - UPDATED

Apr 25, 2008

MS Trial Alert: Clinical Trial of Sex Hormone Estriol Recruiting Women with MS to Participate - UPDATED

Summary:

The National MS Society is funding a team of investigators at seven medical centers to conduct a two-year, controlled clinical trial of an estrogen (estriol) added to standard therapy to treat MS. Investigators administer either oral estriol along with Copaxone® (glatiramer acetate, Teva Pharmaceutical Industries Ltd.) or Copaxone plus inactive placebo to 130 women with relapsing-remitting MS. If successful, this clinical trial could lay the groundwork for a larger, definitive trial that could lead to a new treatment option for women with MS, an option that would be a pill, not an injection.

Importantly, the exclusion criteria for the study have recently changed, such that patients previously treated with an interferon or Copaxone will no longer be excluded.

Seven Centers Recruiting Patients:

The estriol trial is taking place at seven medical centers across the U.S. Women between 18-50 who are diagnosed with relapsing remitting MS and are interested in participating in this clinical trial should contact the nearest site to discuss their eligibility:

Institution

Coordinator

Phone

University of California, Los AngelesDr. Barbara Giesser

Mike Montag

310-825-7313

Washington University, St. LouisDr. Anne Cross

Terri Radacke

314-747-1404

Univ. Med. & Dent. of New Jersey, New BrunswickDr. Suhayl Dhib-Jalbut

Yaritza Rosario

732-235-7099

Ohio State University, ColumbusDr. Deborah Joanne Lynn

Lisa Hafer

614-293-7877

University of ChicagoDr. Anthony Reder

Mildred Valentine

773-702-9812

University of Utah, Salt LakeDr. John Rose

Julia Klein

801-582-1565 x2014

Univ. of Texas Southwestern, DallasDr. Elliot Frohman

Gina Remington

(214)645-0560

This study, costing more than $5 million, is being funded by the National MS Society and the National Institute of Neurological Disorders and Stroke. Pipex Pharmaceuticals is also supporting the trial.

Rationale:

Estriol levels rise to very high levels naturally during late pregnancy, a time when most women’s MS disease activity declines. This led some to suspect that estriol may be responsible for this easing of symptoms during pregnancy. Dr. Rhonda Voskuhl (University of California, Los Angeles) and others explored this lead in mice with MS-like disease, and later, with National MS Society support, Dr. Voskuhl conducted a small, early-phase trial of estriol in 12 women with MS. Results in mice showed that estriol treatment was indeed protective. Results in the pilot trial showed that estriol treatment decreased disease activity in women with relapsing-remitting MS.

According to Dr. Voskuhl, the trial principal investigator, in using estriol they “aim to simulate some of the disease protection offered by pregnancy. We are very enthusiastic about this new agent since it has decades of known safety and since it will be given as a pill, not a shot.” She further states, "Estriol treatment also has the potential to be more potent in halting disability in MS, since estrogens have been shown in animal models to be not only anti-inflammatory, but also to directly reduce brain injury."

Trial Details/Eligibility:

The two-year study is a double-blind, placebo-controlled trial that will take place at seven sites in the U.S. (listed above). Investigators will administer estriol in pill form to women between the ages of 18-50 who have a diagnosis of relapsing-remitting MS. The oral treatment will be given in combination with subcutaneously injected Copaxone, a standard treatment for MS, for 2 years. The team is evaluating effects of the treatment combination on relapse rates and several clinical and magnetic resonance imaging measures of disability progression.

Contact:

For more information, contact the study sites listed above, or please see the study’s listing (NCT00451204) on ClinicalTrials.gov.

Copaxone is a registered trademark of Teva Pharmaceutical Industries Ltd.