Fycompa in Catamenial Epilepsy

NCT ID: NCT05201703

Last Updated: 2024-07-31

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-09
• Study Completion Date: 2023-12-15

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 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.

Conditions

Catamenial Epilepsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fycompa 4 mg daily

Group Type: EXPERIMENTAL

Fycompa

Intervention Type: DRUG

Fycompa 4 mg daily

Fycompa 4 mg daily with a boost to 6 mg daily

Group Type: ACTIVE_COMPARATOR

Fycompa with a boost

Intervention Type: DRUG

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.

Interventions

Fycompa

Fycompa 4 mg daily

Intervention Type: DRUG

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.

Intervention Type: DRUG

Other Intervention Names

Perampanel; Perampanel

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Eisai Inc.

INDUSTRY

Sponsor Role: collaborator

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Katherine Zarroli, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

University of Florida

Jacksonville, Florida, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

IRB202102694

Identifier Type: -

Identifier Source: org_study_id