Authorised Therapeutic exploratory (Phase II) Focal epilepsy

Efficacy of probenecid on cluster seizures during dosage reduction of Anti Seizure Medication (ASM) in presurgical focal epilepsy video-EEG monitoring

EU CTIS ID: 2024-519133-29-00

What this study is testing

To assess the efficacy of PBN administration on the cessation of seizure recurrence in patients experiencing a cluster seizure upon discontinuation of ASM for pre-surgical hospital video EEG monitoring.

  • Therapeutic exploratory (Phase II)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Patients between 6 and 50 years old
  • Children weighing at least 20 kg or adults weighing more than 50 kg
  • With focal seizures epilepsy
  • Requiring video-EEG recording in Epilepsy Monitoring Units (EMU) for the presurgical evaluation of a focal epilepsy, with planned Anti-Seizure Medication (ASM) withdrawal in order to precipitate seizure occurrence, or without dose reduction in the case of epilepsy whose natural history suggests the appearance of seizures without withdrawal.
  • Able to take an oral therapy
  • Ability to record the patient > 12 hours after the second seizure of the cluster

You likely can't join if

  • Hypersensitivity to PBN or to any of the excipients (Microcrystalline cellulose, Hypromellose, Sodium carboxymethylamidon, Colloidal anhydrous silica, Magnesium stearate)
  • Pregnant or breast-feeding woman
  • Known or identified impaired renal function (creatinine clearance < 50 ml/min) in children and adults
  • Lithiasis diathesis
  • Treatment with the following drugs: penicillins and other cephalosporins, acetylsalicylic acid, methotrexate, paracetamol, naproxen, indomethacin, ketoprofen, lorazepam, rifampicin, aciclovir, ganciclovir, zidovudine, sulfonamide
  • Acute gout attack
See the full eligibility criteria
Who can join
  • Patients between 6 and 50 years old
  • Children weighing at least 20 kg or adults weighing more than 50 kg
  • With focal seizures epilepsy
  • Requiring video-EEG recording in Epilepsy Monitoring Units (EMU) for the presurgical evaluation of a focal epilepsy, with planned Anti-Seizure Medication (ASM) withdrawal in order to precipitate seizure occurrence, or without dose reduction in the case of epilepsy whose natural history suggests the appearance of seizures without withdrawal.
  • Able to take an oral therapy
  • Ability to record the patient > 12 hours after the second seizure of the cluster
  • Having received informed information about the study and having signed a consent form to participate in the study. Written consent of both holders of parental authority for minor patients
  • Affiliated or beneficiary to a social security scheme
What rules you out
  • Hypersensitivity to PBN or to any of the excipients (Microcrystalline cellulose, Hypromellose, Sodium carboxymethylamidon, Colloidal anhydrous silica, Magnesium stearate)
  • Pregnant or breast-feeding woman
  • Known or identified impaired renal function (creatinine clearance < 50 ml/min) in children and adults
  • Lithiasis diathesis
  • Treatment with the following drugs: penicillins and other cephalosporins, acetylsalicylic acid, methotrexate, paracetamol, naproxen, indomethacin, ketoprofen, lorazepam, rifampicin, aciclovir, ganciclovir, zidovudine, sulfonamide
  • Acute gout attack
  • Hyperuricemia secondary to cancer chemotherapy, radiotherapy or myeloproliferative neoplasia
  • Primary hyperuricemia due to overproduction of uric acid
  • Participation in an interventional clinical study (drug, medical device, etc.)
  • Patient benefiting from legal protection

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 0-17 years, 18-64 years. The study team makes the final eligibility decision.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.