Cincinnati among Sites for Study of Antiepileptic Drugs During Pregnancy

Man poses for photo

Michael Privitera, MD, Director of the UC Epilepsy Center. Photo by UC Academic Health Center Communications Services.

The University of Cincinnati (UC) will participate in a multicenter, $8.9 million study designed to assess the safety of newer antiepileptic drugs used in pregnancy, both for the mother and the child. The study is known as MONEAD, for Maternal Outcomes and Neurodevelopmental Effects of Antiepileptic Drugs. Funding, spread over a 10-year period, will come from the National Institutes of Health’s National Institute of Neurological Disorders and Stroke.

Michael Privitera, MD, Professor of Neurology and Director of the UC Epilepsy Center, one of nine centers within the UC Gardner Neuroscience Institute, will lead the effort at the Cincinnati site. Joining him on the UC team will be Jennifer Cavit, MD, Associate Professor of Neurology, and Kellie Flood-Shaffer, MD, Associate Professor of Obstetrics and Gynecology. MONEAD’s principal investigator is Kimford Meador, MD, Professor of Neurology at the Emory School of Medicine in Atlanta.

MONEAD follows the NEAD (Neurodevelopmental Effects of Antiepileptic Drugs) study, which assessed the effect of several drugs on cognitive function of 309 children whose mothers received the drugs during pregnancy. It resulted in a landmark New England Journal of Medicine article, along with changes in U.S. Food and Drug Administration labeling of the antiepileptic drug valproate.

The study, published in the Journal’s April 16, 2009, edition, included a recommendation that valproate (marketed under the brand name Depakote in the United States) not be used as a first choice drug in women of child-bearing age.

“MONEAD is a necessary and appropriate follow-up study to NEAD, where UC Health University Hospital was the No. 1 enrolling site,” says Privitera. “We look forward to a successful MONEAD study with UC as a key participant.”

In addition to assessing newer antiepileptic drugs, MONEAD will differ from NEAD by assessing the safety of these drugs not just for the child but also for the mother. Specifically, Privitera says, MONEAD will assess three major areas of outcome:

  • Which drug causes the lowest incidence of malformations or other problems in children born to mothers with epilepsy receiving antiepileptic drugs.
  • Does having epilepsy and/or taking antiepileptic drugs increase the risk of pregnancy complications such as ecclampsia (seizures in a pregnant woman not related to a pre-existing brain condition) or other problems?
  • Does pregnancy cause worsening of the epilepsy in the mother?

MONEAD officially began Aug. 1, 2012, with enrollment expected to begin Feb. 1, 2013. (The first six months are devoted to preparation, including organization and obtaining regulatory approvals.) A total of 19 sites are participating, including Columbia University, the University of Pittsburgh and the University of Southern California in addition to UC and Emory.

“Studies have shown that women who receive antiepileptic drugs during pregnancy, in general, are at higher risk of physical malformations in their children,” Privitera says. “But it’s dangerous to forgo antiepileptic drugs during pregnancy, because uncontrolled seizures can harm the unborn child as well as the mother.”

Because some people with epilepsy respond to one drug and not to others, Privitera says, the challenge for doctors is to identify the proper drug and determine the minimally effective dose that will keep seizures from happening. Additionally, the patient should understand the potential risks and benefits and weigh them with her physician.

“No matter what medication they’re receiving, women with epilepsy should work closely with their doctors in planning pregnancy and be closely monitored during pregnancy to minimize the risk of mother and child,” Privitera says.

For more information, contact the UC Gardner Neuroscience Institute at 866-941-8264. For an appointment with a UC Health neurologist for epilepsy or suspected seizure disorder, call 513-475-8730.

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