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Study on Perampanel Treatment Before Surgery for Patients with Progressive Glioblastoma

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of the medication Perampanel in patients with progressive glioblastoma, a type of brain cancer that continues to grow despite treatment. The study will compare the effects of Perampanel to a placebo, which is a substance with no active medication, to understand how Perampanel might help in managing the disease.

The purpose of the study is to explore how Perampanel affects the growth of the tumor and certain biological markers in the tumor tissue. Participants in the study will receive either Perampanel or a placebo before undergoing surgery to remove the tumor. The study will monitor changes in the tumor's size and other characteristics using MRI scans, which are imaging tests that help visualize the inside of the body.

Throughout the study, participants will be closely observed to assess the impact of the treatment on their health and the tumor's progression. The study aims to provide valuable insights into the potential benefits of Perampanel for patients with progressive glioblastoma, contributing to the development of more effective treatment strategies for this challenging condition.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on specific criteria such as age, cognitive state, and previous treatments.
A negative pregnancy test is required for female patients with reproductive potential before starting treatment.
Step 2
Randomization and initial assessment
Participants are randomly assigned to receive either the active medication, perampanel, or a placebo.
Initial assessments include MRI scans to evaluate the tumour's current state.
Step 3
Medication administration
Participants take Fycompa 2 mg film-coated tablets or placebo orally.
The medication is administered daily leading up to the scheduled surgery.
Step 4
Pre-surgical evaluation
MRI scans are conducted to assess changes in tumour volume and connectivity scores.
These evaluations help determine the effects of the medication before surgery.
Step 5
Surgical procedure
Surgery is performed to remove the tumour tissue.
A sufficient amount of tissue is collected for further analysis.
Step 6
Post-surgical follow-up
Participants continue to be monitored through MRI scans to evaluate post-surgical tumour volume.
Health-related quality of life and cognitive function are assessed using standardized questionnaires.
Step 7
End of treatment and final assessment
The treatment phase concludes, and a final assessment is conducted to evaluate overall outcomes.
Participants are monitored for any side effects for three days after the end of treatment.

Who can join the trial?

12 criteria

The patient must have a confirmed diagnosis of glioblastoma that is getting worse or has come back after one or two previous treatments, which included radiation and medication.
The patient must be able to understand the reasons and effects of the study treatment and procedures.
Female patients who can have children must use an approved birth control method during the study and for four weeks after the study medication ends.
Female patients who can have children must have a negative pregnancy test before starting the treatment.
The patient must need surgery to remove the tumor, and it should be safe to wait up to five weeks for the surgery.
There should be enough tumor tissue (at least 0.5 cm³) available for specific tests related to the study.
The tumor must be getting worse according to specific medical guidelines called RANO criteria.
The patient must be 18 years or older.
The patient must have a Karnofsky Performance Status score of 60% or higher, which means they can take care of themselves and do some daily activities.
The patient must have a life expectancy of more than three months.
The patient must be willing and able to take part in regular tests and questionnaires about their thinking abilities and quality of life.
The patient must provide written informed consent, which means they agree to participate in the study after understanding all the details.

Who cannot join the trial?

3 criteria

Patients who have a different type of brain tumor other than progressive glioblastoma cannot participate.
Patients who are not willing to follow the treatment plan as assigned by the study cannot participate.
Patients who are not planning to undergo surgery cannot participate.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Charite Universitaetsmedizin Berlin KöR
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Berlin, Germany
Goethe University Frankfurt
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Frankfurt, Germany
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
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Munich, Germany

Trial locations

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Investigated drugs

Perampanel is a medication being studied for its potential benefits in patients with progressive glioblastoma, a type of brain tumor. In this clinical trial, Perampanel is given to patients before they undergo surgery. The goal is to see if Perampanel can change certain patterns in the tumor tissue and possibly slow down the growth of the tumor. The effects are measured using advanced imaging techniques to assess changes in the tumor.

Perampanel

What is already known about the treatment

Perampanel – Perampanel is administered orally in tablet form. It is currently being studied in clinical trials for its potential use in treating progressive glioblastoma, a type of brain cancer. The main therapeutic indication for Perampanel in this context is to evaluate its effectiveness in altering mRNA expression patterns and reducing tumor growth before surgery. At the molecular level, Perampanel works by blocking certain receptors in the brain, which may help in reducing tumor activity. It is classified as an antiepileptic drug, although its use in glioblastoma is still under investigation.

Investigated diseases

Progressive Glioblastoma – Progressive glioblastoma is a type of brain cancer that originates from glial cells, which support nerve cells in the brain. It is characterized by rapid growth and a tendency to invade surrounding brain tissue, making it difficult to remove completely through surgery. As the disease progresses, it can cause symptoms such as headaches, seizures, and neurological deficits, depending on the tumor's location. The tumor often recurs after initial treatment, leading to further progression. This progression is marked by increased tumor size and worsening of symptoms. The disease is known for its aggressive nature and resistance to conventional therapies.