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NCT00044252 · ClinicalTrials.gov registry record
Role of Hormones in Susceptibility to Seizures in Women With Epilepsy
A clinical trial, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- Completed
- Registry status
- 50
- Enrollment target
NCT00044252 is a clinical trial that has completed, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 50 participants.
The verdict
NCT00044252 has completed, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- COMPLETED
- Registry status
- 50 participants
- Enrollment target
Study Summary
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 th
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2002-07-26 |
| Est. Completion | 2008-01-22 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00044252
The ClinicalTrials.gov registry entry for NCT00044252 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 0 interventions.
NCT00044252 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00044252 about?
NCT00044252 is a clinical study titled "Role of Hormones in Susceptibility to Seizures in Women With Epilepsy". 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 t...
What is the current status of trial NCT00044252?
This trial is currently completed. The enrollment target is 50 participants. The study started on 2002-07-26. Estimated completion is 2008-01-22.
Who is sponsoring clinical trial NCT00044252?
This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total clinical trials registered on ClinicalTrials.gov.
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