Fycompa for Catamenial Epilepsy

Age: 18 - 65

Sex: Female

Trial Phase: Phase 4

Sponsor: University of Florida

Must be taking: Anti-epileptic drugs

Must not be taking: Systemic hormonal contraception

Disqualifiers: Pregnancy, Breastfeeding, Neurologic disorders, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

This trial is testing perampanel as an additional treatment for women who have seizures related to their menstrual cycle. Perampanel works by blocking certain brain receptors to help prevent these seizures.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants should have had seizures despite trying at least one first-line anti-epileptic drug, so you may continue your current epilepsy medications.

Is Fycompa safe for treating catamenial epilepsy?

The provided research articles do not contain specific safety data for Fycompa (perampanel) in the treatment of catamenial epilepsy or other conditions.¹ ² ³ ⁴ ⁵

How does the drug Fycompa differ from other treatments for catamenial epilepsy?

Fycompa is unique because it is specifically being studied for catamenial epilepsy, a condition without standard treatments, and it may offer a novel approach by targeting the unique hormonal fluctuations associated with the menstrual cycle that influence seizure patterns.⁵ ⁶ ⁷ ⁸ ⁹

Research Team

Katherine Zarroli, MD

Principal Investigator

University of Florida

Eligibility Criteria

This trial is for women aged 18-50 with catamenial epilepsy, which worsens around their menstrual period. They must have regular cycles and focal onset seizures that haven't improved despite trying at least one anti-seizure medication. Women can't join if they're using hormonal birth control, are pregnant or breastfeeding, have a progressive illness, or are experiencing severe mental health crises.

Inclusion Criteria

You are between 18 and 50 years old.

Willingness and ability to comply with scheduled visits and study procedures

Women who have regular periods that come every 21 to 35 days.

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Exclusion Criteria

Pregnancy or breastfeeding

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)

Women on systemic hormonal contraception

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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive add-on perampanel (Fycompa) treatment for catamenial epilepsy

2 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

Fycompa

Trial OverviewThe study tests Fycompa (perampanel), an AMPA receptor antagonist thought to reduce seizure activity related to hormone changes during the menstrual cycle. Some participants will receive an additional boost of Fycompa to assess its effectiveness in treating seizures that coincide with menstruation.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Fycompa 4 mg dailyExperimental Treatment1 Intervention

Group II: Fycompa 4 mg daily with a boost to 6 mg dailyActive Control1 Intervention