Fycompa for Catamenial Epilepsy

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.

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.

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.

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.

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.¹³⁵⁶⁷