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

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-519133-29-00
Acronym
GHD_2024_12
Enrollment
192
Registered
2025-10-17
Start date
Unknown
Completion date
Unknown
Last updated
2025-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Focal epilepsy

Brief summary

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

Detailed description

Introduction of benzodiazepines or increase in weaned antiepileptic medication (if weaned) within 12 hours of treatment administration, Time spent in seizure in minutes, assessed by the blinded neurologist on video and EEG recording, Occurrence of tonic-clonic generalized seizure, assessed by the blinded neurologist on video and EEG recording, Occurrence of a status epilepticus, assessed by the blinded neurologist on video and EEG recording, Seizure-related injury (bone or tooth fracture, hematoma) assessed by the blinded neurologist, 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, Number of seizures during the rest of video EEG monitoring, assessed by the blinded neurologist on video and EEG recording, Evolution of heart rate and blood pressure measurements from treatment administration to 2 hours post-administration, Adverse and serious adverse events

Interventions

DRUGSANTURIL 500 mg comprimé sécable
DRUGplacebo

Sponsors

Fondation A De Rothschild
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
0 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
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

Secondary

MeasureTime frame
Introduction of benzodiazepines or increase in weaned antiepileptic medication (if weaned) within 12 hours of treatment administration, Time spent in seizure in minutes, assessed by the blinded neurologist on video and EEG recording, Occurrence of tonic-clonic generalized seizure, assessed by the blinded neurologist on video and EEG recording, Occurrence of a status epilepticus, assessed by the blinded neurologist on video and EEG recording, Seizure-related injury (bone or tooth fracture, hematoma) assessed by the blinded neurologist, 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, Number of seizures during the rest of video EEG monitoring, assessed by the blinded neurologist on video and EEG recording, Evolution of heart rate and blood pressure measurements from treatment administration t

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026