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Trials / Not Yet Recruiting

Not Yet RecruitingNCT07318870

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

Status
Not Yet Recruiting
Phase
Phase 2
Study type
Interventional
Enrollment
600 (estimated)
Sponsor
Fondation Ophtalmologique Adolphe de Rothschild · Network
Sex
All
Age
6 Years – 50 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
DRUGProbenecidOral 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.
OTHERPlaceboPlacebo administration in a scheme similar to experimental treatment

Timeline

Start date
2026-01-01
Primary completion
2029-02-01
Completion
2029-02-01
First posted
2026-01-06
Last updated
2026-01-06

Source: ClinicalTrials.gov record NCT07318870. Inclusion in this directory is not an endorsement.