Maternal Outcomes and Neurodevelopmental Effects of Antiepileptic Drugs (MONEAD)

The National Institute of Neurological Disorders and Stroke, part of the National Institutes of Health, is looking for individuals to participate in clinical studies.  Participating in clinical trials allows you to play an active role in research on the nature and causes of many disorders of the brain and nervous system, and to possibly help physician-scientists develop future treatments.  The information below is designed to help you quickly learn about actively recruiting research studies for which you or someone you know may be eligible.

Description:

The purpose of this study is to discover how antiepileptic drugs (AED) affect pregnancy outcomes for both the mother and child, including obstetrical complications, seizures, and the long-term effects of AED on children.

AED often are used to help control seizures in women with epilepsy.  Many cannot stop taking these medications even if they become pregnant.  During pregnancy, the doses of medications may be changed to keep seizures under control.  However, the effects of these medications and the different dosages on pregnancy and on unborn children and their development are not fully known. 

The goal of the MONEAD study is to determine how AED (including different dosages) affect pregnancy and the long-term effects these medications have on the mothers and children including the children’s behavior and thinking abilities.  Exposure to anti-seizure medications through the womb as well as through breast milk will be considered.  The differences in the effects of the medications and different doses, and problems during pregnancy and birth as well as the children’s family history and environment also will be considered.

Eligibility Criteria:

Inclusion:

• Pregnant women with epilepsy up to 20 weeks gestation, healthy pregnant women without epilepsy up to 20 weeks gestation, or non-pregnant women with epilepsy.
• Ability to maintain a daily medical diary.
• Access to a telephone for phone contacts. Criteria applicable for pregnant women only.
• Ability for follow-up through 6 years after giving birth.  For non-pregnant women, study duration is only 18 months.

Exclusion:

• Ongoing drug abuse (including alcohol) or sequelae of drug abuse.
• History of active, ongoing psychogenic non-epileptic spells.
• History of positive Syphilis test.
• History of Human Immunodeficiency Virus (HIV) positive test.
• Progressive cerebral disease (e.g., multiple sclerosis, progressive brain tumor).
• Presence of other major medical illness (e.g., diabetes, cancer).
• Any medical, psychiatric, or other condition that, in the judgment of the investigator, is a contraindication to protocol participation or impairs ability to give informed consent.
• Exposure to known teratogens during pregnancy, excluding antiepileptic drugs.

Study Design: 

Study Locations: 

For more information:

Contact: Gene Moore, telephone: 843-261-4805; email: neadgene@knology.net; or Hayley Loblein, telephone: 301-251-1161 ext. 2972; email: monead@emmes.com; or visit: http://clinicaltrials.gov/ct2/show/NCT01730170

Last Reviewed April 8, 2013