Summary: The National MS Society is funding a team of investigators at 15 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 175 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.If you live in/near one of the above places and are interested in volunteering, be sure to contact the appropriate person ASAP! This was placed on the NMSS website on 6/10/11 and it didn't say what the deadline is. I think this is very exciting; I think Estriol has promise based on the previous research I have done regarding Estriol and MS (see Future Therapies Continued (BG-12 & Estriol)).
Fifteen Centers Recruiting Patients: The estriol trial is taking place at 15 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 UCLA; Dr. Barbara Giesser Mike Montag 310-794-4020 Washington University, St. Louis; Dr. Anne Cross Debbie Kemp 314-362-3839 UMDNJ, New Brunswick; Dr. Suhayl Dhib-Jalbut Yaritza Rosario 732-235-7099 OSU, Columbus; Dr. Michael Racke Andrea Schertzer 614-366-3757 University of Chicago; Dr. Anthony Reder Mildred Valentine 773-702-9812 University of Utah, Salt Lake; Dr. John Rose Julia Klein 801-582-1565 x2014 U. of Texas Southwestern, Dallas; Dr. A. Courtney Gina Remington 214-645-0560 Johns Hopkins U., Baltimore; Dr. John Ratchford E'tona Ford 410-502-2489 University of Colorado, Aurora; Dr. John Corboy Haley Steinert 303-724-4172 U. of New Mexico, Albuquerque; Dr. Corey Ford Lori Bachert 505-272-8905 U. of Pennsylvania, Philadelphia; Dr. Dina Jacobs Vanessa Zimmerman 215-349-5162 Dartmouth Med. Sch., Lebanon, NH; Dr. E. Lallana Laurie Rizzo 603-653-9947 U. of Kansas, Kansas City; Dr. Sharon Lynch Kelly Dickerson 913-588-0080 U. of Minnesota, Minneapolis; Dr. Gareth Parry Susan Rolandelli 612-624-5978 Mayo Clinic Arizona, Scottsdale; Dr. D. Wingerchuk Irene Galasky 480-301-6104
This study, costing more than $5 million, is being funded by the National MS Society – through the support of the Southern California Chapter and other chapters and private donors – and the National Institute of Neurological Disorders and Stroke. Adeona Pharmaceuticals is providing drug for 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 principle 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 15 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.
Thursday, June 30, 2011
From the NMSS website: