Phase III Progesterone Therapy Trial for Women with Epilepsy Has Favorable Outcome

Newswise — Baltimore, December 3 – Seizures in women of childbearing age commonly show patterns of exacerbation that involve hormones as a factor. Investigators today reported the favorable outcome of a multicenter randomized, double-blinded, placebo-controlled phase III clinical trial of progesterone therapy in reducing these perimenstrually exacerbated (catamenial) seizures. Results of the NIH-sponsored study are being presented during the American Epilepsy Society’s 65th annual meeting here at the Baltimore Convention Center. (Abstract 3.191)

Progesterone is a naturally occurring steroid known to dampen neuronal excitability and seizures. The purpose of the clinical trial was to compare progesterone versus placebo in lessening seizures in women with partial epilepsy.

“We found that progesterone can provide a clinically important benefit for a substantial portion of women with catamenial seizures,” says lead investigator Andrew G. Herzog, M.D., M.Sc., of Harvard University. “And, the level of perimenstrual seizure exacerbation is a significant predictor of women most likely to benefit from this hormonal therapy.”

The proportion of responders to progesterone therapy increased relative to the increased level of perimenstrual seizure exacerbation; whereas, no significant difference in responder rate was observed in women with seizures that did not show substantial perimenstrual exacerbation, i.e threefold or greater increase in average daily seizure frequency.

The clinical trials were conducted at the Beth Israel Deaconess Medical Center and Brigham and Women’s Hospital Boston, Thomas Jefferson Hospital, Philadelphia, University of Southern California’s Keck School of Medicine, and the University of Maryland, Department of Neurology.

Editors Note: Authors of this study will be available at a press briefing at 12:00 noon, Saturday, December 3 in the onsite press room, Room 336, of the Baltimore Convention Center.: To join the breifing by phone - 1-866-740-1260; PIN 5867508#

About the American Epilepsy Society (AES)The American Epilepsy Society, based in West Hartford, CT, seeks to advance and improve the treatment of epilepsy through the promotion of research and education for healthcare professionals. Society membership includes epileptologists and other medical professionals, allied healthcare professionals, and scientists concerned with the care of people who have seizure disorders.

Information Contacts:Peter Van Haverbeke, AES Media Relations, cell 703-927-9639Natalie Judd, Big Voice Communications, cell 203-605-9515, office 203-389-5223