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 Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 2 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of the drug Fycompa for women with catamenial epilepsy, a type of epilepsy that worsens around the menstrual cycle. The trial compares two groups: one taking 4 mg of Fycompa daily and another starting at 4 mg and increasing to 6 mg daily. Women experiencing focal onset seizures that worsen during their period and have had at least two such seizures a month despite other treatments may be suitable for this study. As a Phase 4 trial, this research aims to understand how the already FDA-approved and effective treatment benefits more patients.

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.

What is the safety track record for this treatment?

Research shows that perampanel, also known as Fycompa, is generally well-tolerated by people with epilepsy. Studies have demonstrated that doses of 4 mg, 8 mg, or 12 mg per day can significantly reduce seizures. The FDA has already approved this medication for treating other types of epilepsy, indicating a known safety record.

A large study of patients using perampanel found it effectively reduced seizures without causing major side effects for most people. Some patients might experience side effects like dizziness or sleepiness, but these are usually manageable. Overall, evidence suggests that perampanel is safe at the doses being studied. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike most treatments for catamenial epilepsy that often involve hormonal therapies or general anti-epileptic drugs, Fycompa, also known as perampanel, offers a unique approach. It works by specifically targeting AMPA receptors, which play a crucial role in the transmission of excitatory signals in the brain. This mechanism can potentially provide better seizure control with fewer hormonal side effects. Additionally, the study is exploring different dosing strategies, including a boost from 4 mg to 6 mg daily, to optimize its effectiveness, making it a promising alternative to current options.

What evidence suggests that Fycompa might be an effective treatment for catamenial epilepsy?

Research shows that Fycompa (perampanel) can help treat certain types of epilepsy. In earlier studies, participants taking perampanel experienced fewer seizures, with some stopping seizures altogether; specifically, 11 people achieved this over a year. Additionally, seven people had at least a 75% reduction in seizures. The medication works by blocking specific parts of the brain, reducing seizure activity. This trial will evaluate Fycompa for catamenial epilepsy, with participants receiving either a consistent dose of 4 mg daily or an increased dose of 6 mg daily during the menstrual cycle. ^{1 3 5 6 7}

Who Is on the Research Team?

Katherine Zarroli, MD

Principal Investigator

University of Florida

Are You a Good Fit for This Trial?

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

Willingness and ability to comply with scheduled visits and study procedures

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

You have been diagnosed with focal onset seizures, confirmed by your medical history and an EEG test.

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Fycompa

Trial Overview

The 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.

How Is the Trial Designed?

Group I: Fycompa 4 mg daily Experimental Treatment 1 Intervention

Group II: Fycompa 4 mg daily with a boost to 6 mg daily Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

Eisai Inc.

Industry Sponsor

Trials

524

Recruited

161,000+

Founded

Eisai Inc. was established in 1995 as the U.S. subsidiary of Eisai Co., Ltd.

Headquarters

Woodcliff Lake, NJ, USA

Known For

Neurology and Oncology

Top Products

Aricept (donepezil), Lenvima (lenvatinib), Leqembi (lecanemab), Halaven (eribulin)

Lynn Kramer

Eisai Inc.

Chief Medical Officer since 2019

MD

Tatsuyuki Yasuno

Eisai Inc.

Chief Executive Officer since 2023

MBA from Kellogg School of Management, Northwestern University; Bachelor of Political Science from Waseda University

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05201703?term=perampanel&viewType=Table&rank=1

NCT05201703 | Fycompa in Catamenial Epilepsy

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.

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9159293/

The efficacy and safety of adjunctive perampanel for the ...

Our meta‐analysis results indicate that adjunctive treatment of PER at a daily dose of 4, 8, or 12 mg significantly reduced the number of seizures in patients ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05201703?term=perampanel&viewType=Table&rank=1&tab=results

Study Results | Fycompa in Catamenial Epilepsy

An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...

4.

neurologylive.com

neurologylive.com/view/filling-therapeutic-need-potential-perampanel-treat-catamenial-epilepsy

Potential of Perampanel to Treat Catamenial Epilepsy

Treatment with perampanel over a year resulted in seizure freedom for 11 patients. Seven patients experienced at least 75% reductions, 3 at ...

5.

withpower.com

withpower.com/trial/phase-4-epilepsy-2-2022-c4781

Fycompa for Catamenial Epilepsy · Info for Participants

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

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5083075/

A Review of Clinical Efficacy and Safety in Epilepsy - PMC

Results showed a statistically significant reduction in the frequency of seizures for patients on 8-mg and 12-mg perampanel compared with placebo (−30.5% and − ...

7.

cdn.clinicaltrials.gov

cdn.clinicaltrials.gov/large-docs/03/NCT05201703/Prot_000.pdf

Version 3.0, March 17, 2022 INVESTIGATOR INITIATED ...

Rationale: Approximately one-third of WWE have catamenial epilepsy, or cyclic seizure exacerbations in relation to the menstrual cycle.