CU Denver Researchers Seeking Women with Multiple Sclerosis for a Research Study Testing Whether a Female Hormone can Improve Cognitive Abilities
Rocky Mtn. MS Center neurologists are seeking women with relapsing-remitting, secondary-progressive or primary-progressive multiple sclerosis (MS) to participate in a year-long study testing whether a female hormone taken in pill form can result in cognitive improvements.
Multiple sclerosis is an autoimmune disease of the central nervous system that attacks the tissue surrounding the brain’s nerve fibers. Called myelin, this tissue can be thought of as the insulation wrapped around an electrical wire. When the myelin is damaged, it interferes with the ability of the nerves to send signals to and from the brain, resulting in symptoms that can include balance problems, memory and vision loss and more.
About 50 percent of people diagnosed with MS will develop problems with cognition. Currently, there are no FDA-approved treatments targeting cognitive function in MS patients. This study will test oral estriol, a form of estrogen produced in significant amounts during pregnancy, combined with standard FDA-approved MS drugs and compare the results to those found in women getting the standard MS therapy with an oral placebo.
Neurologists are seeking women aged 18 to 50 who have had MS for 15 years or less and who are on a stable dose of standard MS treatment with Copaxone, Betaseron (or Extavia), Rebif, Avonex, Gilenya, Aubagio, Tecfidera, or receiving no treatment.
Researchers hope to enroll 64 volunteers at multiple sites to participate in the study, which includes cognitive testing when they enter the clinical trial, at six months and at one year. Women who smoke, are pregnant, breast feeding or who have other serious medical conditions are not eligible for the study.
It has long been common knowledge that pregnant women with MS experience a sharp drop in disease symptoms during pregnancy, said Dr. Rhonda Voskuhl, the director of UCLA’s Multiple Sclerosis Program who has conducted research into estriol and who is leading this clinical trial.
Produced by the placenta, Estriol is virtually undetectable until pregnancy, when it progressively increases. It is thought that it suppresses a woman’s immune system when she is pregnant so that the fetus will not be seen by the body as a foreign “invader.”
“The beauty of estriol is that it is not a shot and can be taken in pill form, and also that it’s not a new drug. It has decades of safety behind it,” said Voskuhl, who also holds the Jack H. Skirball Chair for Multiple Sclerosis at UCLA.
For years estriol has been in widespread use in Europe and Asia as hormone replacement therapy for women experiencing menopause symptoms. The fact that the pill already exists, she said, should dramatically reduce the cost of treatment. Most importantly, the drug potentially provides a one-two punch against MS, both reducing the ability of immune cells to attack the brain while also making it more resistant to damage if any immune cells do make it through.
In 2002, Voskuhl completed a pilot study in which 10 non-pregnant women with MS were given estriol, yielding what she described as “pretty remarkable” results – an 80 percent drop in inflammatory lesions in the brain, a hallmark of the disease.
In March 2007, Voskuhl headed up a much larger trial of estriol, one that involves 150 patients at multiple locations. This study is looking to establish whether oral treatment with estriol induces a decrease in relapses when used in combination with Copaxone in subjects with relapsing- remitting MS.
This current double-blind, placebo-controlled study seeks to compare women getting estriol with women getting a placebo in an effort to establish whether estriol results in an improvement in cognitive function. Volunteers interested in enrolling should call Barby Halliday at (303) 724-4717 for more information and to undergo a 20-minute telephone screening to determine eligibility.
For more information on the study, click here.
It is estimated that more than 2.1 million people are affected by MS worldwide. Because the Centers for Disease Control and Prevention does not require physicians in the United States to report new cases, and because symptoms can be completely invisible, the prevalence of MS in the U.S. can only be estimated.
-Rocky Mtn MS Center on the Anschutz Medical Campus-
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Dr. John Corboy
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