Fycompa in Catamenial Epilepsy

Catamenial Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05201703
• Other study ID #: IRB202102694
• Status: Recruiting
• Phase: Phase 4
• Start date: March 9, 2022
• Est. completion date: December 15, 2023

Study information

• Verified date: June 2023
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 55
• Est. completion date: December 15, 2023
• Est. primary completion date: December 15, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Catamenial Epilepsy
• Epilepsy

Intervention

Drug:
• Fycompa
Fycompa 4 mg daily
• Fycompa with a boost
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.

Locations

Country	Name	City	State
United States	University of Florida	Jacksonville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	Eisai Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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