Phase 3 Study of Progesterone vs Placebo Therapy
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 294
- Locations
- 15
- Primary Endpoint
- Percent of Women Who Show a Greater Than 50% Decline in Average Daily Seizure Frequency
Study Overview
Brief 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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 13 Years to 45 Years (Child, Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subject must be between the ages of 13 and
- •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 Criteria
- •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
Arms & Interventions
Catamenial Epilepsy: Progesterone Lozenges
Subjects with catamenial epilepsy received 200 mg progesterone lozenges
Intervention: Progesterone Lozenges (Biological)
Catamenial Epilepsy: Placebo Lozenges
Subjects with catamenial epilepsy received matched placebo lozenges
Intervention: Matched Placebo Lozenges (Other)
Noncatamenial Epilespy:Progesterone Lozenges
Subjects without catamenial epilepsy received 200 mg progesterone lozenges
Intervention: Progesterone Lozenges (Biological)
Noncatamenial Epilespy: Placebo Lozenges
Subjects without catamenial epilepsy received matched placebo lozenges
Intervention: Matched Placebo Lozenges (Other)
Outcomes
Primary Outcomes
Percent of Women Who Show a Greater Than 50% Decline in Average Daily Seizure Frequency
Time Frame: 9 years
Percent of women who show a greater than 50% decline in average daily seizure frequency
Secondary Outcomes
- 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)
- Percent of Women Who Show a >50% Decline in Average Daily Seizure Frequency for the Most Severe Seizure Type.(9 years)
- Changes in Serum Progesterone Levels in Subjects at Baseline and After Treatment.(9 years)
- Change in Serum Levels of Antiepileptic Drugs on Progesterone and Placebo for Subjects With Catamenial and Non-catamenial Epilepsy.(9 years)
Investigators
Andrew Herzog
Professor of Neurology
Beth Israel Deaconess Medical Center