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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| placebo | Placebo Comparator | Placebo administration in a scheme similar to experimental treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Secondary exclusion criteria (before randomization) :
- 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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amelie Yavchitz, Dr | Contact | +33148036454 | ayavchitz@for.paris |
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| Placebo | Other | Placebo administration in a scheme similar to experimental treatment |
|
| ID | Term |
|---|---|
| D004828 | Epilepsies, Partial |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D011339 | Probenecid |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
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