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Abstract Details

Natural Progesterone Reduces Seizures in Women with Epilepsy with Strong Catamenial Tendency: A Pilot Study
Epilepsy/Clinical Neurophysiology (EEG)
Epilepsy/Clinical Neurophysiology (EEG) Posters (7:00 AM-5:00 PM)
095
To assess efficacy of natural progesterone therapy in women with hormone sensitive seizures (HSS).
Self-reported HSS occur in up to 80% of women with epilepsy (WWE) and are due to alterations in estrogen and progesterone across the menstrual cycle. Progesterone therapy has demonstrated efficacy in treatment of WWE with predominant HSS.
This was a crossover study with 2-month baseline followed by randomization to natural progesterone (Prometrium; 100mg BID for 1 month, then 200mg BID) followed by placebo or vice versa each for 3 months total. Subjects recorded menses and determined ovulation using ovulation kits. WWE >18 years with cycles 25-35 days duration, minimum two-fold increase in seizures during perimenstrual (M), periovulatory (O) or luteal (L) phase and minimum mean monthly frequency of two seizures/one cluster were included. Treatment during either M phase: day -7 to +3, O phase: 10 days surrounding ovulation, or L phase: 10 days during second half of menstrual cycle was administered. Percent change in mean monthly seizure frequency from baseline to month optimal titration was compared between arms using an independent t-test.
Of 20 enrolled subjects, only 10(50%) met criteria for HSS. Progesterone treatment produced a significant reduction in mean seizure frequency from baseline 51.7%(SD 36.8) for 400mg daily and 27.3%(SD 70.8) for 200mg daily versus -5.9%(SD 113.9) for placebo (p=0.44). One subject achieved seizure freedom. 6(60%) were responders (≥50% reduction). Adverse events were limited to diarrhea in 1 case which resolved after month 1 of treatment.

While our study was underpowered due to the low rate of HSS confirmation, natural progesterone reduced seizures in WWE with HSS (two-fold or greater seizure increase during specified phase of menstrual cycle) and was tolerable. Nearly 50% who reported HSS did not meet standard criteria.
Authors/Disclosures
Alise K. Carlson, MD (Cleveland Clinic)
PRESENTER 		Dr. Carlson has received research support from Biogen (fellowship grant 16696-P-FEL).
Nancy R. Foldvary-Schaefer, DO, FÂ鶹´«Ã½Ó³»­ (Cleveland Clinic) Dr. Foldvary-Schaefer has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Jazz. The institution of Dr. Foldvary-Schaefer has received research support from Jazz. The institution of Dr. Foldvary-Schaefer has received research support from Suven. The institution of Dr. Foldvary-Schaefer has received research support from Takeda. Dr. Foldvary-Schaefer has received publishing royalties from a publication relating to health care. Dr. Foldvary-Schaefer has received publishing royalties from a publication relating to health care.