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Fycompa in Catamenial Epilepsy

NCT05201703 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2024-07-31

Study results available
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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

Interventions

DRUG

Fycompa

Fycompa 4 mg daily

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.

Sponsors & Collaborators

  • Eisai Inc.

    collaborator INDUSTRY

  • University of Florida

    lead OTHER

Principal Investigators

  • Katherine Zarroli, MD · University of Florida

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-09
Primary Completion
2023-12-15
Completion
2023-12-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05201703 on ClinicalTrials.gov