What side effects are associated with this type of intervention?

Common treatments for Catamenial Epilepsy include antiepileptic drugs (AEDs) such as Perampanel, which is a noncompetitive AMPA receptor antagonist. Known side effects of Perampanel include dizziness, somnolence, fatigue, irritability, and gait disturbances. Other AEDs like levetiracetam and lamotrigine, which are also used for epilepsy management, can cause side effects such as mood changes, dizziness, and skin rashes. It is important for patients to discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

There is limited specific information on FDA approvals for the treatment of Catamenial Epilepsy. However, Perampanel (Fycompa), a noncompetitive AMPA receptor antagonist, is being studied for its potential in treating this condition. Other treatments for epilepsy that have been FDA-approved include antiepileptic drugs like lamotrigine, levetiracetam, and valproate, which are used broadly for various types of epilepsy. These drugs work through different mechanisms compared to Perampanel but are part of the broader category of antiepileptic medications.

What other types of research exist?

Promising novel alternatives to Perampanel for Catamenial Epilepsy patients include Ganaxolone, a synthetic neuroactive steroid approved for certain epilepsy syndromes, and hormonal treatments such as progesterone therapy, which targets hormonal fluctuations. Additionally, advancements in neuromodulation techniques like vagus nerve stimulation (VNS) and responsive neurostimulation (RNS) may offer new avenues for treatment.

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Fycompa for Catamenial Epilepsy

Phase 4

Waitlist Available

Led By Katherine Zarroli, MD

Research Sponsored by University of Florida

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (2 months) and treatment (2 months)

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Fycompa may cause dizziness, sleepiness, fatigue, irritability and aggression. It might also affect coordination and balance leading to falls or gait disturbances. There's a risk of serious psychiatric side effects like suicidal thoughts or behavior.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (2 months) and treatment (2 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (2 months) and treatment (2 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (2 months) and treatment (2 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Responder Rate (Percent of Patients Experiencing a 50% or Greater Reduction in Seizures) Relative to Baseline Seizure Frequencies

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fycompa

2017

N/A

~6330

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Perampanel, a noncompetitive AMPA receptor antagonist, works by inhibiting the excitatory neurotransmission mediated by AMPA receptors, which are involved in the propagation of epileptic seizures. This mechanism is particularly relevant for Catamenial Epilepsy, a condition where seizure frequency is influenced by hormonal fluctuations during the menstrual cycle. By reducing excitotoxicity linked to progesterone receptor activity, perampanel can help stabilize neuronal activity and decrease seizure occurrences. This targeted approach is crucial for Catamenial Epilepsy patients, as it addresses the specific hormonal triggers that exacerbate their condition.

Perampanel monotherapy for the treatment of epilepsy: Clinical trial and real-world evidence.