PerSurge (NOA-30, EU-CT number 2023-503938-52-00) is a multicenter, double-blind, two-arm, Phase IIa superiority trial evaluating perampanel, an AMPA receptor inhibitor, administered perioperatively in progressive or recurrent glioblastoma using an extended window-of-opportunity design. The study aims to assess tumor cell network connectivity and tumor growth dynamics under perampanel versus placebo; co-primary endpoints are tumor-neuron network connectivity at single-cell transcriptome level in resected tissue and AI-based assessment of tumor growth dynamics on T2/FLAIR MRI prior to resection. Eligible adults have progressive or recurrent glioblastoma with a planned surgical resection and an expected safe waiting interval, confirmed by a safety MRI. Participants are randomized 1:1 to receive either perampanel or placebo over a 60-day treatment and observation period beginning 30 days before the planned resection, which itself is not a study intervention (total n = 66). Key secondary endpoints include pre- and post-surgical contrast-enhanced MRI and post-surgical T2/FLAIR MRI parameters, quality of life, cognitive testing, overall survival (OS) and progression-free survival (PFS), and frequency of epileptic seizures.
PerSurge is a multicenter Phase IIa study investigating the drug perampanel in patients with progressive or recurrent glioblastoma. Perampanel is an already approved epilepsy medication that, in earlier research, was able to block connections between tumor cells and nerve cells in the brain, slowing tumor growth. The goal of this study is to find out whether perampanel can reduce these tumor-nerve connections in patients and slow down tumor growth. Adults with progressive glioblastoma who have a planned surgical tumor removal and a safe waiting period before surgery may take part. The 66 participants are randomly and blindly assigned to receive either perampanel or a placebo, and are followed for 60 days around the planned surgery. Alongside the effects on tumor cells, the study also measures quality of life, cognitive function, and how often epileptic seizures occur.
