Clinical trials help to determine if a drug is safe and effective for people with MS. People with MS who are willing to volunteer in these studies make it possible for all of us to look forward to new and better therapies.
Clinical Trial Basics
The process is complicated. Many factors are involved in making sure that a study is conducted properly and that the results are valid. The U.S. food and Drug Administration requires therapies to undergo three phases of clinical trials before they can be approved to treat people with MS:
- Phase I - The first step is to determine safety. In a small number of healthy volunteers or persons with MS, the investigators determine how the human body reacts to the therapy.
- Phase II - If the therapy proves to be safe, studies begin to determine the effectiveness of the drug in people with MS. These studies may last several months or several years, and involve larger numbers of people. The study is "controlled" - that is, the drug is compared with the standard treatment, or an inactive placebo.
- Phase III - If an MS drug shows effectiveness, an even larger study is conducted in hundreds of people to gain a better understanding of the drug's effectiveness and possible side effects. These multi-center studies can span several years and several countries.
- Following FDA approval, post-marketing studies (phase IV) might be conducted to assess long-term safety and effectiveness.
A selection of local trials approved by the National MS Society are detailed below:
Clinical Trial of Sex Hormone Estriol Recruiting Women with MS to Participate
In the first effort of its kind in MS, UCLA neurologist Dr. Rhonda Voskuhl is leading a team of investigators at seven medical centers to conduct a two-year, controlled clinical trial of a sex hormone added to standard therapy to treat MS. Investigators plan to 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. Its results may also have implications for women with other autoimmune diseases, such as rheumatoid arthritis. Women with relapsing-remitting MS interested in the possibility of participating in the trial should consult with their physicians or contact Julia Klein, NP at 801.582.1565 ext. 2014.
Fatigue Study
The University of Utah (Department of Exercise and Sport Science) has designed a research project to examine the effects of increased body temperature on measures of brain excitability. They hope to gain further understanding about why heat produces fatigue in multiple sclerosis. Individuals between the ages of 18 and 55 with relapsing-remitting multiple sclerosis (RRMS) and fatigue, especially heat-related fatigue, are eligible to participate. For more information, please contact Andrea White at 801.573.5387 or andrea.white@hsc.utah.edu.