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Progesterone vs Placebo Therapy for Women With Epilepsy

Information source: Beth Israel Deaconess Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Epilepsy

Intervention: Natural Progesterone (Biological)

Phase: Phase 3

Status: Completed

Sponsored by: Beth Israel Deaconess Medical Center

Official(s) and/or principal investigator(s):
Andrew G Herzog, M.D., M.Sc., Principal Investigator, Affiliation: Beth Israel Deaconess Medical Center

Summary

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.

Clinical Details

Official title: Phase 3 Study of Progesterone vs Placebo Therapy

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Number of women who show a greater than 50% decline in average daily seizure frequency

Secondary outcome:

Number of women who show a >50% decline in average daily seizure frequency for the most severe seizure type.

Number of women who show a greater than 50% decline in average daily seizure frequency for secondary generalized, complex partial and simple partial seizures considered separately

Number of women who show a decline in average daily seizure frequency.

Change in average daily seizure frequency during the entire cycle.

Change in average daily seizure frequency during the period of progesterone use (Day 14 to -1) and no progesterone use (Day 1 to 13).

Change in seizure severity on treatment versus baseline.

Change in quality of life score.

Association of change in seizure frequency with changes in serum levels of progesterone, allopregnanolone, estradiol and estradiol/progesterone.

Association of change in seizure frequency with changes in serum levels of antiepileptic drugs

Detailed description: 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

Minimum age: 13 Years. Maximum age: 45 Years. Gender(s): 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.

Locations and Contacts

University of Southern California, Keck School of Medicine, Los Angeles, California 90033, United States

Emory University School of Medicine, Atlanta, Georgia 30322, United States

Johns Hopkins Bayview Medical Center; Johns Hopkins Hospital, Baltimore, Maryland 21287, United States

University of Maryland, Baltimore, Maryland 21201, United States

Beth Israel Deaconess Medical Center, Harvard Neuroendocrine Unit, Boston, Massachusetts 02215, United States

Brigham and Women's Hospital, Boston, Massachusetts 02115, United States

Henry Ford Hospital, Detroit, Michigan 48202, United States

MINCEP Epilepsy Care, Minneapolis, Minnesota 55416, United States

Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire 03756, United States

Columbia Medical Center, New York, New York 10032, United States

New York Presbyterian Hospital- Weill Medical College of Cornell University, Comprehensive Epilepsy Center, New York, New York 10021, United States

Ohio State University, Columbus, Ohio 43210, United States

Thomas Jefferson University Hospital, Comprehensive Epilepsy Center, Philadelphia, Pennsylvania 19107, United States

Montreal Neurological Institute, Montreal, Quebec H3A 2B4, Canada

University of Virginia, Charlottesville, Virginia 22908, United States

Additional Information

Related 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.

Herzog AG, Klein P, Ransil BJ. Three patterns of catamenial epilepsy. Epilepsia. 1997 Oct;38(10):1082-8.

Starting date: October 2000
Last updated: July 20, 2010

Page last updated: August 23, 2015

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