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Epilepsy |
Seizure Disorders |
Clinical Trial: Progesterone vs Placebo Therapy for Women with Epilepsy
This study is currently recruiting patients.
|
Purpose
There is considerable evidence to suggest that natural progesterone has anti-seizure properties. The purpose of this study is to determine if progesterone supplement during the second half of the menstrual cycle lessens seizure frequency in women with epilepsy.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Epilepsy | Drug: Natural Progesterone | Phase II |
MedlinePlus related topics: Epilepsy
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control
Expected Total Enrollment: 150
Study start: October 2000; Expected completion: August 2004
This is a 6-month study. The first 3 months will gather baseline information on seizures, antiepileptic drug levels , menstrual cycles, hormone levels, emotional function, and quality of life. The second 3 months will assess the effects of treatment on these parameters.
Eligibility
Ages Eligible for Study: 13 Years - 45 Years, Genders Eligible for Study: Female
Criteria
INCLUSION: 1. Subject must be between the ages of 13 and 45. 2. Subject must have a history of seizures (documented by EEG). 3. Subject must have had at least 2 seizures or auras per month during the past 3 months. 4. Subject must be on stable antiepileptic drug therapy for at least 2 months. 5. Subject must have cycle intervals between 21 and 35 days during 6 months prior to entry.
EXCLUSION: 1. Subject that is pregnant or lactating. 2. Subject that is on major tranquilizers, antidepressant medications, or reproductive hormones. 3. Subject that is unable to document seizures.
Location and Contact Information
Georgia
Emory University School of Medicine, Atlanta, Georgia, 30322, United States; Recruiting
Melanee Newman, RN 4047784249 melanee_newman@emoryhealthcare.org
Page B Pennell, MD, Principal Investigator
Massachusetts
Beth Israel Deaconess Medical Center, Harvard Neuroendocrine Unit, Boston, Massachusetts, 02215, United States; Recruiting
Kristen M Fowler 781-431-0273 kfowler@caregroup.harvard.edu
Andrew G Herzog, M.D.,M.Sc., Principal Investigator
New York
New York Presbyterian Hospital- Weill Medical College of Cornell University, Comprehensive Epilepsy Center, New York, New York, 10021, United States; Recruiting
Cynthia Harden, M.D., Principal Investigator
Pennsylvania
Thomas Jefferson University Hospital, Comprehensive Epilepsy Center, Philadelphia, Pennsylvania, 19107, United States; Recruiting
Gwendolyn Taylor 215-955-4673 gwendolyn.taylor@jefferson.edu
Michael Sperling, M.D., Principal Investigator
More Information
http://www.bidmc.harvard.edu/neurology/neurendo.html
Publications
Herzog AG. Progesterone therapy in women with complex partial and secondary generalized seizures. Neurology. 1995 Sep;45(9):1660-2.
Herzog AG. Progesterone therapy in women with epilepsy: a 3-year follow-up. Neurology. 1999 Jun 10;52(9):1917-8. No abstract available.
Record last reviewed: February 2005
Last Updated: February 24, 2005
Record first received: January 15, 2002
ClinicalTrials.gov Identifier: NCT00029536
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- (National Women's Health Information Center, OWH, HHS)
- A Pacemaker for the Brain (Cleveland Clinic)
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