Progesterone vs Placebo Therapy for Women With Epilepsy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Phase 3 Study of Progesterone vs Placebo Therapy

Conditions
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Epilepsy

Intervention / Treatment
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* Biological: Progesterone Lozenges
* Other: Matched Placebo Lozenges


Participation Criteria
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Eligibility Criteria
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INCLUSION: Subject must be between the ages of 13 and 45. Subject must have a history of seizures (documented by EEG). Subject must have had at least 2 seizures or auras per month during the past 3 months. Subject must be on stable antiepileptic drug therapy for at least 2 months. Subject must have cycle intervals between 21 and 35 days during 6 months prior to entry. EXCLUSION: Subject that is pregnant or lactating. Subject that is on major tranquilizers, antidepressant medications, or reproductive hormones. Subject that is unable to document seizures. Subject that has progressive neurological or systemic disorder or > 2-fold elevation in liver enzyme levels

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This was a phase III, randomized, double-blind, placebo-controlled, multicenter trial. Randomization was carried out separately for women with and without catamenial epilepsy, 2:1 to progesterone or placebo.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Catamenial Epilepsy: Progesterone Lozenges<br>Subjects with catamenial epilepsy received 200 mg progesterone lozenges | Biological: Progesterone Lozenges<br>* 200mg Progesterone Lozenges<br>|
| Placebo Comparator: Catamenial Epilepsy: Placebo Lozenges<br>Subjects with catamenial epilepsy received matched placebo lozenges | Other: Matched Placebo Lozenges<br>* Matched Placebo Lozenges<br>|
| Experimental: Noncatamenial Epilespy:Progesterone Lozenges<br>Subjects without catamenial epilepsy received 200 mg progesterone lozenges | Biological: Progesterone Lozenges<br>* 200mg Progesterone Lozenges<br>|
| Placebo Comparator: Noncatamenial Epilespy: Placebo Lozenges<br>Subjects without catamenial epilepsy received matched placebo lozenges | Other: Matched Placebo Lozenges<br>* Matched Placebo Lozenges<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| Change in Serum Levels of Antiepileptic Drugs on Progesterone and Placebo for Subjects With Catamenial and Non-catamenial Epilepsy. |  | 9 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Epilepsy, Seizure, Hormone, Progesterone, Catamenial