Efficacy of Probenecid on Cluster Seizures During Anti Seizure Medication Withdrawal in Presurgical Focal Epilepsy Video-EEG Monitoring

NCT07318870 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: GHD_2024_12
• Study Type: interventional
• Target: 600
• Locations: 0 countries
• Sites: N/A

Brief Summary

ProbCluster trial aims at making the proof of concept of antiseizure efficacy of the old antigout PBN in SC, in which Panx1 involvement is relevant on SC pathophysiology and in which efficient therapies are still lacking. The trial will be performed on patients with focal epilepsy in presurgical evaluation undergoing video-EEG monitoring, a setting characterized by a high risk of SC and an efficient video-EEG monitoring of seizures, reducing the risk of erroneous report based on patient home assessment. PBN is a good candidate for a repurposing in epilepsy, due to its brain penetration allowing Panx1 in situ blockade and of its good security profile. The repurposing process allows a faster, safer and cheaper development.

Conditions

Focal Epilepsy

Outcome Measures

Primary Outcomes (1)

• Cessation of seizure recurrence in patients experiencing a cluster seizure

  Patients without seizure between 60 min and 12h after experimental treatment administration, assessed by the neurologist on video-EEG recording

  Time period from Day 0 to maximum Day 21

Study Arms (2)

probenecid

EXPERIMENTAL

Oral administration of PBN at a dose of 3g in adults or children weighting \> 50 kg; at a dose of 2g in children weighting 35 to 50 kg; and at a dose of 1g in children weighting 20 to 34 kg.

Drug: Probenecid

placebo

PLACEBO COMPARATOR

Placebo administration in a scheme similar to experimental treatment.

Other: Placebo

Interventions

Probenecid DRUG

Oral administration of PBN at a dose of 3g in adults or children weighting \> 50 kg; at a dose of 2g in children weighting 35 to 50 kg; and at a dose of 1g in children weighting 20 to 34 kg.

probenecid

Placebo OTHER

Placebo administration in a scheme similar to experimental treatment

placebo

Eligibility Criteria

• Age: 6 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients between 6 and 50 years old
• weighting \> 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 ASM withdrawal in order to precipitate seizure occurrence
• 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.

You may not qualify if:

• Hypersensitivity to PBN or to any of the excipients (Microcrystalline cellulose, Hypromellose, Sodium carboxymethylamidon, Colloidal anhydrous silica, Magnesium stearate)
• Impaired renal function (creatinine clearance \< 50 mL/min)
• Lithiasis diathesis
• Treatment by the following drugs: penicillins cephalosporins, acetylsalicylic acid, methotrexate, acetaminophen, naproxen, indomethacin, ketoprofen, meclofenamate, lorazepam, rifampicin, acyclovir, ganciclovir and zidovudine, sulfonamide, dyprophylline
• Acute gout attack
• Hyperuricemia secondary to cancer chemotherapy, radiotherapy or myeloproliferative neoplasia
• Primary hyperuricemia due to overproduction of uric acid.
• Pregnant or breast-feeding woman
• Patient benefiting from legal protection
• \- Patient not randomized: Not experiencing at least 2 seizures lasting less than 10 minutes in 6 hours or less period (defining a SC) during the video-EEG monitoring period OR having no seizure recorded before the cluster.
• Patients secondarily excluded will be excluded before randomization and will be replaced.

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

MeSH Terms

Conditions

Epilepsies, Partial

Interventions

Probenecid

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds

Central Study Contacts

Amelie Yavchitz, Dr

CONTACT

+33148036454; ayavchitz@for.paris

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2025
• First Posted: January 6, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): February 1, 2029
• Last Updated: January 6, 2026

Record last verified: 2025-12