Efficacy of probenecid on cluster seizures during dosage reduction of Anti Seizure Medication (ASM) in presurgical focal epilepsy video-EEG monitoring
Key facts
- Where
- Bron, Grenoble Cedex 9, Lille Cedex, Marseille, Paris, Rennes, Rouen Cedex és Toulouse, FranciaországSee the 10 sites
- Phase
- 2. fázis
Where in Franciaország
- Hospices Civils de LyonBron, FranciaországTaking people
- Centre Hospitalier Universitaire Grenoble AlpesGrenoble Cedex 9, FranciaországTaking people
- Centre Hospitalier Universitaire De LilleLille Cedex, FranciaországTaking people
- Centre Hospitalier Regional De MarseilleMarseille, FranciaországTaking people
- Assistance Publique Hopitaux de ParisParis, FranciaországTaking people
- Fondation A. de RothschildParis, FranciaországTaking people
- Groupe Hospitalier Universitaire Paris Psychiatrie Et NeuroscienceParis, FranciaországTaking people
- Centre Hospitalier Universitaire de RennesRennes, FranciaországTaking people
- Centre Hospitalier Universitaire RouenRouen Cedex, FranciaországTaking people
- Centre Hospitalier Universitaire de ToulouseToulouse, FranciaországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Fondation A De Rothschild
- Trial code
- EU 2024-519133-29-00
- Record updated
- 2026. október 1.
- Original description
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.Read full original descriptionShow less
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.
Inclusion: Patients between 6 and 50 years old; Adults, of any weight, who are free from malnutrition or any condition affecting their physiology to any significant degree; or children and adolescents weighing more than 20 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.
Exclusion: Treatment with the following drugs: acetylsalicylic acid and/or methotrexate (Note: the following medications require caution when co-administered: penicillins, quinolones, cephalosporins including cefadroxil, paracetamol, naproxen, indomethacin, ketoprofen, lorazepam, thiopental, olanzapine, famotidine, clofibrate, valaciclovir, aciclovir, ganciclovir, cidofovir, zidovudine, angiotensin-converting enzyme inhibitors and dyprophylline); Participation in an interventional clinical study (drug); Hyperuricemia secondary to cancer chemotherapy, radiotherapy or myeloproliferative neoplasia; Hypersensitivity to PBN or to any of the excipients (Microcrystalline cellulose, Hypromellose, Sodium carboxymethylamidon, Colloidal anhydrous silica, Magnesium stearate); Known or identified impaired renal function (creatinine clearance < 50 ml/min) in children and adults; Pregnant or breast-feeding woman; Lithiasis diathesis; Acute gout attack; Primary hyperuricemia due to overproduction of uric acid; Patient benefiting from legal protection.