Fycompa in Catamenial Epilepsy

Study Overview
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Brief Summary
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The purpose of the proposed investigation is to carry out a pilot study of add-on perampanel (Fycompa) in women with perimenstural (C1) catamenial epilepsy. Perampanel, a noncompetitive AMPA receptor antagonist, is uniquely positioned to decrease progesterone receptor mediated excitotoxicity. This mechanism of action would allow a novel use of perampanel as an effective treatment of C1 catamenial epilepsy.

Official Title
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Pilot Study of Add-On Fycompa (Perampanel)Treatment for Catamenial Epilepsy

Conditions
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Catamenial Epilepsy

Intervention / Treatment
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* Drug: Fycompa
* Drug: Fycompa with a boost


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female Diagnosis of focal onset seizures (FOS) i. Established by clinical history and an EEG ii. Patients with a normal EEG may be included if they met other diagnostic criteria based on clinical history Presumably ovulatory women based on menstrual cycles of 21-35 days from beginning of menstrual flow to the beginning of the next menses ≥18-50 years old ≥2 unprovoked seizures per month despite drug trials with ≥1 first-line anti-epileptic drugs (AED) Seizures must show a C1 catamenial pattern in 2 of 3 documented cycles i. C1 pattern will be defined as a two-fold increase in average daily seizure frequency during the menstrual phase, as compared to the follicular and luteal phases of the ovulation cycle, in 2 of 3 documented cycles. The menstrual phase will be defined as days -3 to +3 of the menstrual cycle (where onset of menstruation is defined as day 1) (Herzog et al, 1997). Of note, in the NIH Progesterone Trial, the level of catameniality was 1.69 based on Herzog et al. (1997) criteria though this trial will use a level of 2 to include women only with high levels of perimenstrual catamenial exacerbation. Willingness and ability to comply with scheduled visits and study procedures Exclusion Criteria: Progressive neurologic or systemic disorder Use of systemic hormonal contraception during 3 months prior to enrollment (however, subjects with a progestin-releasing IUD who still have monthly periods may be enrolled) a. Women on system hormonal contraception will be excluded as these women are not ovulatory Subject is pregnant or breastfeeding Active suicidal or homicidal ideation Comatose individuals.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fycompa 4 mg daily<br> | Drug: Fycompa<br>* Fycompa 4 mg daily<br>* Other names: Perampanel;|
| Active Comparator: Fycompa 4 mg daily with a boost to 6 mg daily<br> | Drug: Fycompa with a boost<br>* Fycompa 4 mg daily with a boost to 6 mg daily a week before the start of your menstruation cycle until Day 4 of your cycle.<br>* Other names: Perampanel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Responder rate (percent of patients experiencing a 50% or greater reduction in seizures) relative to baseline seizure frequencies | To measure the 50% responder rate will be analyzed using Chi square analysis. | Baseline |