Status:
TERMINATED
Fycompa in Catamenial Epilepsy
Lead Sponsor:
University of Florida
Collaborating Sponsors:
Eisai Inc.
Conditions:
Catamenial Epilepsy
Eligibility:
FEMALE
18-50 years
Phase:
PHASE4
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 9 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2023
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT05201703
Start Date
March 9 2022
End Date
December 15 2023
Last Update
July 31 2024
Active Locations (1)
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1
University of Florida
Jacksonville, Florida, United States, 32209