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

January 15, 2002
July 20, 2010
October 2000
June 2010   (final data collection date for primary outcome measure)
Number of women who show a greater than 50% decline in average daily seizure frequency [ Time Frame: 9 years ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00029536 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
Progesterone vs Placebo Therapy for Women With Epilepsy
Phase 3 Study of Progesterone vs Placebo Therapy

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Epilepsy
Biological: Natural Progesterone
200mg Progesterone Lozenges and Matched Placebo Lozenges
  • Experimental: 1
    Progesterone Lozenges
    Intervention: Biological: Natural Progesterone
  • Placebo Comparator: 2
    Matched Placebo
    Intervention: Biological: Natural Progesterone

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
462
June 2010
June 2010   (final data collection date for primary outcome measure)

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.
Female
13 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00029536
2001P-0001408, NINDS NS39466, CRC
Yes
Andrew G. Herzog, MD, Beth Israel Deaconess Medical Center
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
Principal Investigator: Andrew G Herzog, M.D., M.Sc. Beth Israel Deaconess Medical Center
Beth Israel Deaconess Medical Center
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP