Title
Progesterone vs Placebo Therapy for Women With Epilepsy
Phase 3 Study of Progesterone vs Placebo Therapy
Phase
Phase 3Lead Sponsor
Harvard UniversityStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
EpilepsyIntervention/Treatment
progesterone ...Study Participants
294The 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.
200mg Progesterone Lozenges
Matched Placebo Lozenges
Subjects with catamenial epilepsy received 200 mg progesterone lozenges
Subjects with catamenial epilepsy received matched placebo lozenges
Subjects without catamenial epilepsy received 200 mg progesterone lozenges
Subjects without catamenial epilepsy received matched placebo lozenges
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
| Event Type | Organ System | Event Term | Catamenial Epilepsy: Progesterone Lozenges | Catamenial Epilepsy: Placebo Lozenges | Noncatamenial Epilespy:Progesterone Lozenges | Noncatamenial Epilespy: Placebo Lozenges |
|---|
Percent of women who show a greater than 50% decline in average daily seizure frequency
Percent of women who show a >50% decline in average daily seizure frequency for the most severe seizure type.
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
Changes in serum progesterone levels in subjects at baseline and after treatment with progesterone or placebo.
