NCT04497142

Effect of Perampanel on Peritumoral Hyperexcitability in HGG

Pilot Study of Perampanel on Peritumoral Hyperexcitability and Seizure Control in Newly Diagnosed High Grade Glioma

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research study is to learn more about seizures in people with primary brain tumors. It will evaluate whether an antiseizure medication decreases hyperexcitability activity around tumors and prevents seizures. The procedure and study drug involved in this study are: * Electrocorticography * Perampanel (Fycompa)

Detailed description

This research study is a Pilot Study, which is the first time investigators are examining brain activity after taking perampanel. The U.S. Food and Drug Administration (FDA) has approved perampanel as a treatment option for seizures. It has not been approved for the treatment of brain tumors. Recording of brain activity (electrocorticography) during surgery is an established clinical procedure, which will be performed for investigational purposes. This research study is studying brain recordings and perampanel treatment in participants with brain tumors for the following reasons: * People with brain tumors commonly have seizures. * Perampanel was developed as an anti-seizure medication, which works by blocking a signaling pathway between brain cells, mediated by AMPA receptors. * Previous research has shown abnormal brain activity around tumors resulting from increased AMPA receptor activation. * Perampanel is expected to decrease abnormal brain activity and prevent seizures by blocking AMPA receptor signaling. This study involves two groups of participants, one group who receives the antiseizure medication perampanel, and the other group who receives the usual antiseizure medication (typically levetiracetam) at the time of surgery. Participants have the option to choose which group to participate if they have a preference. The research study procedures include screening for eligibility, recording brain activity during surgery, and study treatment including evaluations and follow up visits. Participants will receive the study drug for as long as they do not have serious side effects and their disease does not get worse, up to a maximum of 12 months. It is expected that about 20 people will take part in this research study. The National Institute of Health (NIH) is supporting this study by providing funding for the research. Eisai Inc, a pharmaceutical company, is supporting this research study by providing the study medication.

Conditions

• Glioma, Malignant
• Surgery
• Seizures

Interventions

Type	Name	Description
DRUG	Perampanel	Tablet taken orally 1x daily.
DRUG	Standard of Care	Predetermined standard of care drug and dosing

Timeline

• Start date: 2020-11-05
• Primary completion: 2023-05-16
• Completion: 2023-05-16
• First posted: 2020-08-04
• Last updated: 2024-08-05
• Results posted: 2024-08-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study