Washington, DC, May 30, 2013
A clinical trial to test the effectiveness of magnesium supplementation as a treatment for pseudoxanthoma elasticum (PXE) is underway at the Mount Sinai School of Medicine in New York City, NY. This trial is the first of its kind in PXE history. PXE International is a partner in the trial’s recruitment and research.
PXE is a rare, genetic disorder that causes mineralization in elastic tissue throughout the body. It affects about 1 in 50,000 people. Those diagnosed with PXE often experience changes in the skin, eyes, cardiovascular, and gastrointestinal systems. While research on the disease has accelerated in the past two decades, no known treatment exists for the signs and symptoms PXE causes.
The clinical trial began in January of 2013 and is sponsored by Dr. Mark Lebwohl of Mt. Sinai. Sharon Terry, CEO of PXE International, is a co-principal investigator and is leading the effort to recruit, preliminarily screen, and support participants through education and information in the clinical trial process. “It is very exciting for PXE International to be part of this historical and very meaningful study. We are so excited that it enrolled quickly, a testimony to our years of managing a registry and epidemiological study, and to the quality of the research.”
A total of 44 participants diagnosed with PXE are enrolled in the two-year trial. It is a Phase II, double-blind study in which participants take a magnesium supplement or a placebo daily for one year. Barring any safety concerns, all participants will receive a magnesium supplement during the second year of the trial.
Participants in the trial will undergo clinical evaluations, skin biopsies, and eye examinations every three months. Researchers believe that the magnesium supplement may reduce or eliminate mineralization of elastic tissue, especially in the skin, that people with PXE experience.
While researchers are hopeful that magnesium supplementation will prove to be an effective treatment for PXE, widespread use of it is not currently recommended. Mild side effects, such as diarrhea, nausea, and cramping, can occur; severe side effects such as metabolic alkalosis, hypokalemia, and hypermagnesemia have also been reported but are rare. More will be known once the trial concludes in January 2015. Stay tuned!
For more information on this study, visit:
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PXE International was founded in 1995 to promote research and support individuals affected by pseudoxanthoma elasticum (PXE). We work on behalf of individuals and their families to improve quality of life through advancing research, educating clinicians and supporting individuals.
PXE International is the prime force in conducting basic and clinical research and providing financial support for applied translational research, product development, and treatment development for PXE. We steward the intellectual property to equitably advance products and services around the world for the individuals and families living with PXE.
For more information on PXE International, please visit www.pxe.org .