Fycompa in Catamenial Epilepsy
Primary Purpose
Catamenial Epilepsy
Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Fycompa
Fycompa with a boost
Sponsored by
About this trial
This is an interventional treatment trial for Catamenial Epilepsy
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.
Sites / Locations
- University of FloridaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Fycompa 4 mg daily
Fycompa 4 mg daily with a boost to 6 mg daily
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05201703
First Posted
January 7, 2022
Last Updated
June 7, 2023
Sponsor
University of Florida
Collaborators
Eisai Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05201703
Brief Title
Fycompa in Catamenial Epilepsy
Official Title
Pilot Study of Add-On Fycompa (Perampanel)Treatment for Catamenial Epilepsy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 9, 2022 (Actual)
Primary Completion Date
December 15, 2023 (Anticipated)
Study Completion Date
December 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
Eisai Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Catamenial Epilepsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
55 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Fycompa 4 mg daily
Arm Type
Experimental
Arm Title
Fycompa 4 mg daily with a boost to 6 mg daily
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Fycompa
Other Intervention Name(s)
Perampanel
Intervention Description
Fycompa 4 mg daily
Intervention Type
Drug
Intervention Name(s)
Fycompa with a boost
Other Intervention Name(s)
Perampanel
Intervention Description
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.
Primary Outcome Measure Information:
Title
Responder rate (percent of patients experiencing a 50% or greater reduction in seizures) relative to baseline seizure frequencies
Description
To measure the 50% responder rate will be analyzed using Chi square analysis.
Time Frame
Baseline
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Study is enrolling women of child bearing potential to investigate the use of perampanel in women with perimenstrual catamenial epilepsy
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katherine Zarroli, MD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Layla Jamil
Phone
904-244-9686
Email
layla.jamil@jax.ufl.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Fycompa in Catamenial Epilepsy
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