Progesterone vs Placebo Therapy for Women With Epilepsy

Verified by: Beth Israel Deaconess Medical Center, July 2010
First Received: January 15, 2002 | Last Updated: July 20, 2010 | Phase: Phase 3 | Start Date: October 2000
Overall Status: Completed | Estimated Enrollment: 462
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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...

Brief Summary

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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
  • Study Primary Completion Date: June 2010

Detailed Clinical Trial 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.

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

Outcome Measures for this Clinical Trial

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

Criteria for Participation in this Clinical Trial

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

Clinical Trial Investigator Information

Lead Investigator: Beth Israel Deaconess Medical Center Other

Overall Clinical Trial Officials and Contacts

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

Related Publications

References

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. No abstract available.

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

Citations Reporting Results

Herzog AG, Harden CL, Liporace J, Pennell P, Schomer DL, Sperling M, Fowler K, Nikolov B, Shuman S, Newman M. Frequency of catamenial seizure exacerbation in women with localization-related epilepsy. Ann Neurol. 2004 Sep;56(3):431-4.

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

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

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