Progesterone vs Placebo Therapy for Women With Epilepsy

This study has been completed.
Sponsor:
Collaborators:
Brigham and Women's Hospital
Columbia University
Dartmouth-Hitchcock Medical Center
Emory University
Johns Hopkins University
MINCEP Epilepsy Care
Montreal Neurological Institute and Hospital
Ohio State University
Thomas Jefferson University
University of Maryland
University of Southern California
University of Virginia
Weill Medical College of Cornell University
Information provided by:
Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT00029536
First received: January 15, 2002
Last updated: July 20, 2010
Last verified: July 2010
  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 Intervention Phase
Epilepsy
Biological: Natural Progesterone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 3 Study of Progesterone vs Placebo Therapy

Resource links provided by NLM:


Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • Number of women who show a greater than 50% decline in average daily seizure frequency [ Time Frame: 9 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of women who show a >50% decline in average daily seizure frequency for the most severe seizure type. [ Time Frame: 9 years ] [ Designated as safety issue: Yes ]
  • 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 [ Time Frame: 9 years ] [ Designated as safety issue: Yes ]
  • Number of women who show a decline in average daily seizure frequency. [ Time Frame: 9 years ] [ Designated as safety issue: Yes ]
  • Change in average daily seizure frequency during the entire cycle. [ Time Frame: 9 years ] [ Designated as safety issue: Yes ]
  • Change in average daily seizure frequency during the period of progesterone use (Day 14 to -1) and no progesterone use (Day 1 to 13). [ Time Frame: 9 years ] [ Designated as safety issue: No ]
  • Change in seizure severity on treatment versus baseline. [ Time Frame: 9 years ] [ Designated as safety issue: No ]
  • Change in quality of life score. [ Time Frame: 9 years ] [ Designated as safety issue: No ]
  • Association of change in seizure frequency with changes in serum levels of progesterone, allopregnanolone, estradiol and estradiol/progesterone. [ Time Frame: 9 years ] [ Designated as safety issue: No ]
  • Association of change in seizure frequency with changes in serum levels of antiepileptic drugs [ Time Frame: 9 years ] [ Designated as safety issue: Yes ]

Enrollment: 462
Study Start Date: October 2000
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Progesterone Lozenges
Biological: Natural Progesterone
200mg Progesterone Lozenges and Matched Placebo Lozenges
Placebo Comparator: 2
Matched Placebo
Biological: Natural Progesterone
200mg Progesterone Lozenges and Matched Placebo Lozenges

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

Ages Eligible for Study:   13 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00029536

Locations
United States, California
University of Southern California, Keck School of Medicine
Los Angeles, California, United States, 90033
United States, Georgia
Emory University School of Medicine
Atlanta, Georgia, United States, 30322
United States, Maryland
Johns Hopkins Bayview Medical Center; Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
University of Maryland
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Beth Israel Deaconess Medical Center, Harvard Neuroendocrine Unit
Boston, Massachusetts, United States, 02215
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202
United States, Minnesota
MINCEP Epilepsy Care
Minneapolis, Minnesota, United States, 55416
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New York
New York Presbyterian Hospital- Weill Medical College of Cornell University, Comprehensive Epilepsy Center
New York, New York, United States, 10021
Columbia Medical Center
New York, New York, United States, 10032
United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43210
United States, Pennsylvania
Thomas Jefferson University Hospital, Comprehensive Epilepsy Center
Philadelphia, Pennsylvania, United States, 19107
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
Canada, Quebec
Montreal Neurological Institute
Montreal, Quebec, Canada, H3A 2B4
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Columbia University
Dartmouth-Hitchcock Medical Center
Emory University
Johns Hopkins University
MINCEP Epilepsy Care
Montreal Neurological Institute and Hospital
Ohio State University
Thomas Jefferson University
University of Maryland
University of Southern California
University of Virginia
Weill Medical College of Cornell University
Investigators
Principal Investigator: Andrew G Herzog, M.D., M.Sc. Beth Israel Deaconess Medical Center
  More Information

Publications:
Responsible Party: Andrew G. Herzog, MD, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT00029536     History of Changes
Other Study ID Numbers: 2001P-0001408, NINDS NS39466, CRC
Study First Received: January 15, 2002
Last Updated: July 20, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Beth Israel Deaconess Medical Center:
Epilepsy
Seizure
Hormone
Progesterone
Catamenial

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Progesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2014