Progesterone vs Placebo Therapy for Women With Epilepsy

Beth Israel Deaconess Medical Center294 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

294

Conditions

Epilepsy

Interventions

Progesterone LozengesBIOLOGICAL

200mg Progesterone Lozenges

Matched Placebo LozengesOTHER

Matched Placebo Lozenges

Eligibility

Sex: FEMALEMin age: 13 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Locations (15)

University of Southern California, Keck School of Medicine

Los Angeles, California, United States

Emory University School of Medicine

Atlanta, Georgia, United States

Outcomes

Primary Outcomes

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

Time frame: 9 years

Secondary Outcomes

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.

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

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

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.

Time frame: 9 years

Change in Serum Levels of Antiepileptic Drugs on Progesterone and Placebo for Subjects With Catamenial and Non-catamenial Epilepsy.

Time frame: 9 years

Data from ClinicalTrials.gov

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