Progesterone vs Placebo Therapy for Women With Epilepsy

Epilepsy Clinical Trial

Official title:

Phase 3 Study of Progesterone vs Placebo Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00029536
• Other study ID #: 2001P001408
• Secondary ID: NINDS NS39466CRC
• Status: Completed
• Phase: Phase 3
• First received: January 15, 2002
• Last updated: June 2, 2017
• Start date: October 2000
• Est. completion date: June 2010

Study information

• Verified date: June 2017
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 294
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 13 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Epilepsy

Intervention

Biological:
• Progesterone Lozenges
200mg Progesterone Lozenges

Other:
• Matched Placebo Lozenges
Matched Placebo Lozenges

Locations

Country	Name	City	State
Canada	Montreal Neurological Institute	Montreal	Quebec
United States	Emory University School of Medicine	Atlanta	Georgia
United States	Johns Hopkins Bayview Medical Center; Johns Hopkins Hospital	Baltimore	Maryland
United States	University of Maryland	Baltimore	Maryland
United States	Beth Israel Deaconess Medical Center, Harvard Neuroendocrine Unit	Boston	Massachusetts
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	University of Virginia	Charlottesville	Virginia
United States	Ohio State University	Columbus	Ohio
United States	Henry Ford Hospital	Detroit	Michigan
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	University of Southern California, Keck School of Medicine	Los Angeles	California
United States	MINCEP Epilepsy Care	Minneapolis	Minnesota
United States	Columbia Medical Center	New York	New York
United States	New York Presbyterian Hospital- Weill Medical College of Cornell University, Comprehensive Epilepsy Center	New York	New York
United States	Thomas Jefferson University Hospital, Comprehensive Epilepsy Center	Philadelphia	Pennsylvania

Sponsors (14)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center	Brigham and Women's Hospital, Columbia University, Dartmouth-Hitchcock Medical Center, Emory University, Johns Hopkins University, Minnesota Comprehensive Epilepsy Program, 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

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (4)

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. — View Citation

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

Herzog AG. Progesterone therapy in women with complex partial and secondary generalized seizures. Neurology. 1995 Sep;45(9):1660-2. — View Citation

Herzog AG. Progesterone therapy in women with epilepsy: a 3-year follow-up. Neurology. 1999 Jun 10;52(9):1917-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of Women Who Show a Greater Than 50% Decline in Average Daily Seizure Frequency	Percent of women who show a greater than 50% decline in average daily seizure frequency	9 years
Secondary	Percent of Women Who Show a >50% Decline in Average Daily Seizure Frequency for the Most Severe Seizure Type.	Percent of women who show a >50% decline in average daily seizure frequency for the most severe seizure type.	9 years
Secondary	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	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	9 years
Secondary	Changes in Serum Progesterone Levels in Subjects at Baseline and After Treatment.	Changes in serum progesterone levels in subjects at baseline and after treatment with progesterone or placebo.	9 years
Secondary	Change in Serum Levels of Antiepileptic Drugs on Progesterone and Placebo for Subjects With Catamenial and Non-catamenial Epilepsy.		9 years