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Study of Probenecid for Controlling Cluster Seizures in Patients with Focal Epilepsy During Pre-surgical Video-EEG Monitoring

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What is this trial about?

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

This study focuses on patients with focal epilepsy who require monitoring in specialized units. The research evaluates the effectiveness of probenecid, a medication that will be tested against a placebo to help control seizures that occur in clusters. Cluster seizures happen when a person experiences two or more seizures within a short time period during hospital monitoring.

The study examines how well probenecid works in stopping additional seizures when patients are undergoing special brain monitoring with video-EEG. During this monitoring, patients' regular anti-seizure medications may be reduced to allow doctors to better observe and record their seizures. The medication or placebo will be given by mouth when cluster seizures occur during the monitoring period.

Doctors will observe patients for 12 hours after receiving the study medication to see if it prevents more seizures from occurring. They will also monitor other important factors such as changes in brain electrical activity, heart rate, blood pressure, and any side effects that might occur. The monitoring includes continuous recording of both video and brain wave patterns to ensure accurate observation of any seizure activity.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial admission to monitoring unit
You will be admitted to the Epilepsy Monitoring Unit (EMU) for video-EEG recording.
Your regular anti-seizure medication may be reduced to allow seizures to occur for evaluation purposes.
Step 2
Monitoring period begins
You will be continuously monitored through video recording and EEG (brain electrical activity measurement).
The monitoring will track any seizures that occur during your stay.
Step 3
Medication administration
If you experience two or more seizures within 6 hours (called a cluster seizure), you will receive either:
- Probenecid (Santuril) 500mg tablet taken by mouth, or
- A placebo tablet (inactive substance) taken by mouth
Step 4
Post-medication monitoring
You will be monitored for 12 hours after receiving the medication.
Medical staff will track:
- Any additional seizures
- Your heart rate and blood pressure for the first 2 hours
- Any side effects or complications
Step 5
Extended observation
Monitoring will continue to record:
- Brain activity between seizures
- Any additional seizures that may occur
- Any need for additional anti-seizure medications

Who can join the trial?

8 criteria

Age between 6 and 50 years old
Weight requirements: - Children must weigh at least 20 kg - Adults must weigh more than 50 kg
Must have focal seizures (seizures that start in one specific area of the brain)
Need to undergo video-EEG monitoring (a test that records brain activity and video of seizures) as part of pre-surgical evaluation
Must be able to take medication by mouth
Must be able to stay under observation for at least 12 hours after experiencing a second seizure in a cluster (multiple seizures occurring close together)
Must be willing and able to provide informed consent to participate: - Adults must sign consent forms themselves - For children, both parents/guardians must provide written consent
Must have active social security coverage

Who cannot join the trial?

14 criteria

History of severe allergic reactions or hypersensitivity to perampanel or similar medications
Pregnant women or those planning pregnancy during the study period (pregnancy test required)
Currently breastfeeding mothers
Severe liver problems or abnormal liver function tests
Severe kidney disease or impaired kidney function
History of serious psychiatric conditions including severe depression or suicidal thoughts
Active substance abuse or dependence within the past 12 months
Participation in another clinical trial within the last 30 days
Unable to follow study procedures or attend required visits
History of status epilepticus (prolonged seizures lasting more than 5 minutes) in the past 3 months
Taking medications that could interact with the study drug
Uncontrolled high blood pressure or serious heart conditions
History of non-compliance with medical treatments
Any condition that, in the investigator's opinion, makes participation unsafe

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Verified sites

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Assistance Publique Hopitaux De Marseille
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Marseille, France
CHU Grenoble Alpes
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La Tronche, France
Centre Hospitalier Lyon Sud
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Pierre Benite, France

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Investigated drugs

Probenecid
is a medication that is being studied to help control cluster seizures in patients with epilepsy. It is being tested specifically during the period when patients are reducing their regular anti-seizure medications before undergoing video-EEG monitoring. This medication may help prevent or stop multiple seizures that occur close together (cluster seizures).
Anti-Seizure Medications (ASMs)
are the regular medications that patients with epilepsy take to control their seizures. In this study, these medications are temporarily reduced, which is a standard procedure before certain types of brain monitoring, but this reduction can sometimes trigger seizures.

What is already known about the treatment

Probenecid - A medication traditionally used to treat gout, which is now being investigated for its potential role in treating focal epilepsy during the withdrawal of anti-seizure medications. This drug is administered orally in tablet form and works by blocking organic anion transporters in cell membranes, which may help regulate brain excitability and reduce seizure clusters. In this clinical trial, probenecid is being studied for its ability to prevent or reduce cluster seizures that occur when patients discontinue their regular anti-seizure medications during pre-surgical video-EEG monitoring. It belongs to the class of uricosuric agents, though its potential new application in neurology represents an innovative use of this well-established medication.

Investigated diseases

Focal Epilepsy - A type of epilepsy where seizures begin in a specific area of the brain, affecting one particular region or side. During these seizures, a person may experience various symptoms depending on which part of the brain is involved, such as unusual sensations, involuntary movements, or changes in awareness. The seizures can occur in clusters, meaning multiple seizures happen within a short period. In focal epilepsy, electrical disturbances remain localized to one area of the brain, though sometimes they can spread to other regions. The condition can affect people of any age and may be caused by various factors including brain injury, infections, or structural abnormalities.