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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
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
Minnesota Comprehensive Epilepsy Program
Information provided by (Responsible Party):
Andrew Herzog, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT00029536
First received: January 15, 2002
Last updated: June 2, 2017
Last verified: June 2017
  Purpose
The purpose of this investigation was to determine if cyclic adjunctive progesterone supplement is superior to placebo in the treatment of intractable seizures in women with and without catamenial epilepsy.

Condition Intervention Phase
Epilepsy Biological: Progesterone Lozenges Other: Matched Placebo Lozenges Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
This was a phase III, randomized, double-blind, placebo-controlled, multicenter trial. Randomization was carried out separately for women with and without catamenial epilepsy, 2:1 to progesterone or placebo.
Masking: Participant, Care Provider, 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 Andrew Herzog, Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • Percent of Women Who Show a Greater Than 50% Decline in Average Daily Seizure Frequency [ Time Frame: 9 years ]
    Percent of women who show a greater than 50% decline in average daily seizure frequency


Secondary Outcome Measures:
  • Percent of Women Who Show a >50% Decline in Average Daily Seizure Frequency for the Most Severe Seizure Type. [ Time Frame: 9 years ]
    Percent of women who show a >50% decline in average daily seizure frequency for the most severe seizure type.

  • Percentage 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 ]
    Percentage 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

  • Changes in Serum Progesterone Levels in Subjects at Baseline and After Treatment. [ Time Frame: 9 years ]
    Changes in serum progesterone levels in subjects at baseline and after treatment with progesterone or placebo.

  • Change in Serum Levels of Antiepileptic Drugs on Progesterone and Placebo for Subjects With Catamenial and Non-catamenial Epilepsy. [ Time Frame: 9 years ]

Enrollment: 294
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: Catamenial Epilepsy: Progesterone Lozenges
Subjects with catamenial epilepsy received 200 mg progesterone lozenges
Biological: Progesterone Lozenges
200mg Progesterone Lozenges
Placebo Comparator: Catamenial Epilepsy: Placebo Lozenges
Subjects with catamenial epilepsy received matched placebo lozenges
Other: Matched Placebo Lozenges
Matched Placebo Lozenges
Experimental: Noncatamenial Epilespy:Progesterone Lozenges
Subjects without catamenial epilepsy received 200 mg progesterone lozenges
Biological: Progesterone Lozenges
200mg Progesterone Lozenges
Placebo Comparator: Noncatamenial Epilespy: Placebo Lozenges
Subjects without catamenial epilepsy received matched placebo lozenges
Other: Matched Placebo Lozenges
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   (Child, Adult)
Sexes 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.
  4. Subject that has progressive neurological or systemic disorder or > 2-fold elevation in liver enzyme levels
  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
University of Maryland
Baltimore, Maryland, United States, 21201
Johns Hopkins Bayview Medical Center; Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Beth Israel Deaconess Medical Center, Harvard Neuroendocrine Unit
Boston, Massachusetts, United States, 02215
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
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
Minnesota Comprehensive Epilepsy Program
Investigators
Principal Investigator: Andrew G Herzog, M.D., M.Sc. Beth Israel Deaconess Medical Center
  More Information

Publications:
Responsible Party: Andrew Herzog, Professor of Neurology, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT00029536     History of Changes
Other Study ID Numbers: 2001P001408
NINDS NS39466
CRC
Study First Received: January 15, 2002
Results First Received: March 31, 2017
Last Updated: June 2, 2017

Keywords provided by Andrew Herzog, 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

ClinicalTrials.gov processed this record on July 26, 2017