Fycompa in Catamenial Epilepsy

NCT05201703 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: IRB202102694
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 (2 months) and treatment (2 months)

Study Arms (2)

Fycompa 4 mg daily

EXPERIMENTAL

Drug: Fycompa

Fycompa 4 mg daily with a boost to 6 mg daily

ACTIVE COMPARATOR

Drug: Fycompa with a boost

Interventions

Fycompa DRUG

Fycompa 4 mg daily

Also known as: Perampanel

Fycompa 4 mg daily

Fycompa with a boost 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.

Also known as: Perampanel

Fycompa 4 mg daily with a boost to 6 mg daily

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Study is enrolling women of child bearing potential to investigate the use of perampanel in women with perimenstrual catamenial epilepsy
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Florida: lead
• Eisai Inc.: collaborator

Study Sites (1)

University of Florida

Jacksonville, Florida, 32209, United States

Location

MeSH Terms

Interventions

perampanel

Results Point of Contact

• Title: Dr. Katherine Zarroli
• Organization: University of Florida - Jacksonville

katherine.zarroli@jax.ufl.edu

3025615456

Study Officials

• Katherine Zarroli, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2022
• First Posted: January 21, 2022
• Study Start: March 9, 2022
• Primary Completion: December 15, 2023
• Study Completion: December 15, 2023
• Last Updated: July 31, 2024
• Results First Posted: July 31, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)