Role of Hormones in Susceptibility to Seizures in Women With Epilepsy

Completed

Conditions studied: Epilepsy

In brief

This study will measure and compare hormone levels in women with catamenial epilepsy (epilepsy in which seizures are more frequent during menstrual periods), women with seizures not related to their menstrual cycle, and normal control subjects. It will determine whether there are differences among the three groups in their hormone levels or in how fast the levels change. It will also examine what relationship, if any, exists between hormone changes and seizures in women with catamenial epilepsy. The hormones under study include the gonadal hormones estrone, estradiol and progesterone, and the neuroactive steroids allopregnanolone, pregnenolone, and dehydroepiandrosterone. Women who meet the following criteria may be eligible for this 3-month study: * Between 18 and 45 years of age, with catamenial epilepsy * Between 18 and 45 years of age, with seizures, but not catamenial epilepsy * Between 18 and 45 years of age, without seizures All participants will have a physical examination at the beginning of the study, at each clinic visit, and at completion or withdrawal from the study. In addition, they will undergo the following procedures: Baseline Monitoring For the first 2 months, all participants will keep a diary of their temperature and onset of menses. Women with epilepsy will also record their seizures. Electroencephalography (EEG) Healthy volunteers will have a 45-minute EEG (recording of the electrical activity of the brain) at the beginning of each menstrual cycle and each day during the menses. Women with epilepsy will have continuous EEG monitoring for 8 days, beginning 5 days before their menstrual period is expected. The continuous monitoring can be done on an outpatient basis, using a portable EEG recording device, or as an inpatient, with admission to the hospital for the 8 days of recording. Blood Sampling All participants will have a small blood sample (2 teaspoons) drawn once a day on days 10, 14, 17, 19 and 21 of their menstrual cycle and three times a day on day 6 and for a period of 8 days, starting 5 days before the expected menses and continuing for 3 days of the next cycle. For the days with three blood draws, a small needle that can stay in place for up to 72 hours will be placed in the arm to avoid the discomfort of multiple needle sticks.

Key facts

Study ID

NCT00044252

Run by

National Institute of Neurological Disorders and Stroke (NINDS)

People needed

50

Starts

2002-07-26

Expected to finish

2008-01-22

Last updated by the study team

2017-07-02

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.

You may not qualify if…

• Any of the following conditions are cause for exclusion from the study:
• Any illness requiring chronic drug therapy other than antiepileptic drugs.
• Any history of an illness likely to be adversely affected by the trial.
• Psychiatric hospitalization lasting more than 2 months at any time prior to the study.
• Use of tricyclic antidepressants within 4 weeks prior to randomization and/or anti-psychotic drugs within 2 weeks prior to randomization.
• Children will not be included in this pilot study, because the profile of hormonal secretion undergoes profound changes during puberty.
• Use of illicit drugs, alcoholism or binge drinking as per medical history inventory.
• Women who are unwilling to use an alternative to oral contraceptives for contraception, (double barrier contraceptives, intrauterine device or abstinence), and establish that they are currently not pregnant by submitting to a pregnancy test.
• Exposure to any other investigational drug within 12 weeks prior to randomization.
• Any history of endocrine dysfunction.
• Women will be excluded if they do not have regular menstrual cycle intervals between 27 and 32 days or if they are pregnant, nursing or taking oral contraceptives or other reproductive hormones.
• If a need should arise to change the antiepileptic regime during the study this subject will be excluded and replaced with another patient.
• Women currently taking Phenobarbital or another barbiturate.
• Women who are unwilling to refrain from strenuous exercise during the study.
• Women who are unwilling to refrain from usage of herbal and soy products.

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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