PROBENECID for Focal epilepsy

Stratification factors

• inclusion center

Inclusion criteria

• {"criterion_text":"- Patients between 6 and 50 years old"}
• {"criterion_text":"- Children weighing at least 20 kg or adults weighing more than 50 kg"}
• {"criterion_text":"- With focal seizures epilepsy"}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Able to take an oral therapy"}
• {"criterion_text":"- Ability to record the patient > 12 hours after the second seizure of the cluster"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Affiliated or beneficiary to a social security scheme"}

Exclusion criteria

• {"criterion_text":"- Hypersensitivity to PBN or to any of the excipients (Microcrystalline cellulose, Hypromellose, Sodium carboxymethylamidon, Colloidal anhydrous silica, Magnesium stearate)"}
• {"criterion_text":"- Known or identified impaired renal function (creatinine clearance < 50 ml/min) in children and adults"}
• {"criterion_text":"- Lithiasis diathesis"}
• {"criterion_text":"- Treatment with the following drugs: penicillins and other cephalosporins, acetylsalicylic acid, methotrexate, paracetamol, naproxen, indomethacin, ketoprofen, lorazepam, rifampicin, aciclovir, ganciclovir, zidovudine, sulfonamide"}
• {"criterion_text":"- Acute gout attack"}
• {"criterion_text":"- Hyperuricemia secondary to cancer chemotherapy, radiotherapy or myeloproliferative neoplasia"}
• {"criterion_text":"- Primary hyperuricemia due to overproduction of uric acid"}
• {"criterion_text":"- Participation in an interventional clinical study (drug, medical device, etc.)"}
• {"criterion_text":"- Patient benefiting from legal protection"}
• {"criterion_text":"- Pregnant or breast-feeding woman"}

Primary endpoints

• {"endpoint_text":"- Proportion of patients without seizure between 60 min and 12h after PBN or placebo administration, assessed by the neurologist on video and EEG recording, in patients experiencing SC defined as at least 2 epileptic seizures lasting less than 10 min occurring in 6 hours or less during presurgical hospital videoEEG monitoring for focal epilepsy","definition_or_measurement_approach":"Assessed by the neurologist on video and EEG recording; SC (seizure cluster) is defined as at least 2 epileptic seizures lasting less than 10 minutes occurring in 6 hours or less during presurgical hospital video-EEG monitoring."}

Secondary endpoints

• {"endpoint_text":"- Introduction of benzodiazepines or increase in weaned antiepileptic medication (if weaned) within 12 hours of treatment administration","definition_or_measurement_approach":"Introduction of rescue benzodiazepines or increase in previously weaned antiepileptic medication within 12 hours after treatment administration (as recorded)."}
• {"endpoint_text":"- Time spent in seizure in minutes, assessed by the blinded neurologist on video and EEG recording","definition_or_measurement_approach":"Measured in minutes by the blinded neurologist using video and EEG recordings."}
• {"endpoint_text":"- Occurrence of tonic-clonic generalized seizure, assessed by the blinded neurologist on video and EEG recording","definition_or_measurement_approach":"Occurrence assessed by the blinded neurologist using video and EEG recording."}
• {"endpoint_text":"- Occurrence of a status epilepticus, assessed by the blinded neurologist on video and EEG recording","definition_or_measurement_approach":"Occurrence assessed by the blinded neurologist using video and EEG recording within 12 hours following administration."}
• {"endpoint_text":"- Seizure-related injury (bone or tooth fracture, hematoma) assessed by the blinded neurologist","definition_or_measurement_approach":"Seizure-related injuries (e.g., bone or tooth fracture, hematoma) evaluated by the blinded neurologist."}
• {"endpoint_text":"- Interictal activity quantified by the blinded neurologist on video and EEG recording as the evolution of the number of interictal spikes recorded during 15 minutes, 2 hours after treatment administration compared to the same period the day before","definition_or_measurement_approach":"Interictal spikes counted during a 15-minute period 2 hours after treatment and compared to the same 15-minute period the day before; quantified by the blinded neurologist on video and EEG."}
• {"endpoint_text":"- Number of seizures during the rest of video EEG monitoring, assessed by the blinded neurologist on video and EEG recording","definition_or_measurement_approach":"Count of seizures for the remainder of the video-EEG monitoring, assessed by blinded neurologist."}
• {"endpoint_text":"- Evolution of heart rate and blood pressure measurements from treatment administration to 2 hours post-administration","definition_or_measurement_approach":"Changes in heart rate and blood pressure from administration to 2 hours post-administration measured and recorded."}
• {"endpoint_text":"- Adverse and serious adverse events","definition_or_measurement_approach":"Incidence and description of adverse events and serious adverse events as recorded during study follow-up."}

France

Earliest CTIS Part Ii Submission Date

15-09-2025

Latest Decision Or Authorization Date

17-10-2025

Processing Time Days

32

Number Of Sites

11

Number Of Participants

192

Primary sponsor

Full Name

Fondation A De Rothschild

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France