Official Title: “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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: May 2010

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.

Intervention(s) in this Clinical Trial

• Biological: Natural Progesterone
  • 200mg Progesterone Lozenges and Matched Placebo Lozenges

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Progesterone Lozenges
• Placebo Comparator: 2
  • Matched Placebo

Primary Measures

• Number of women who show a greater than 50% decline in average daily seizure frequency
  • Time Frame: 9 years
    Safety Issue?: Yes

Secondary Measures

• Number of women who show a >50% decline in average daily seizure frequency for the most severe seizure type.
  • Time Frame: 9 years
    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
    Safety Issue?: Yes
• Number of women who show a decline in average daily seizure frequency.
  • Time Frame: 9 years
    Safety Issue?: Yes
• Change in average daily seizure frequency during the entire cycle.
  • Time Frame: 9 years
    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
    Safety Issue?: No
• Change in seizure severity on treatment versus baseline.
  • Time Frame: 9 years
    Safety Issue?: No
• Change in quality of life score.
  • Time Frame: 9 years
    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
    Safety Issue?: No
• Association of change in seizure frequency with changes in serum levels of antiepileptic drugs
  • Time Frame: 9 years
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 13 Years

Maximum Age for this Clinical Trial: 45 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Beth Israel Deaconess Medical Center

Overall Clinical Trial Officials and Contacts

Andrew G Herzog, M.D., M.Sc. Principal Investigator Beth Israel Deaconess Medical Center  

Overall Contact: Andrew Herzog, M.D.,M.Sc. 781-431-0277 aherzog@caregroup.harvard.edu

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00029536

Study ID Number: 2001P-0001408

ClinicalTrials.gov Identifier: NCT00029536

Health Authority: United States: Food and Drug Administration