Focal EpilepsyPhase 2PROBCLUSTERNCT07318870
Efficacy of Probenecid on Cluster Seizures During Anti Seizure Medication Withdrawal in Presurgical Focal Epilepsy Video-EEG Monitoring
A Phase 2 study testing Probenecid in people with Focal Epilepsy, run by Fondation Ophtalmologique Adolphe de Rothschild at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 50 years
- Conditions the study is for
- Focal Epilepsy
- What is being tested?
- Probenecid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 600 participants
- Where
- 2 sitesFrance
- Study dates
- 24 Aug 2026to Sep 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients between 6 and 50 years old
- Adults, of any weight, who are free from malnutrition or any condition affecting their physiology to any significant degree; or children/adolescents weigheing more than 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, or without dose reduction in the case of epilepsy whose natural history suggests the appearence of seizures without withdrawal
- 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.
- Affiliated or beneficiary to a social security scheme
Who cannot join
- Hypersensitivity to PBN or to any of the excipients (Microcrystalline cellulose, Hypromellose, Sodium carboxymethylamidon, Colloidal anhydrous silica, Magnesium stearate)
- Known or identified impaired renal function (creatinine clearance < 50 mL/min) in children and adults
- Lithiasis diathesis
- Treatment by the following drugs: acetylsalicylic acid, methotrexate (note: the following medications require caution when co-administrated: penicillins, quinolones, cephalosporins including cefadroxil, paracetamol, naproxen, indomethacin, ketoprofen, lorazepam, thiopental, olanzapine, famotidine, clofibrate, valaciclovir, aciclovir, ganciclovir, cidofovir, zidovudine, angiotensin converting enzyme inhibitors and dyprophylline)
- Acute gout attack
- Hyperuricemia secondary to cancer chemotherapy, radiotherapy or myeloproliferative neoplasia
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- Primary hyperuricemia due to overproduction of uric acid.
- Participation in an interventional clinical study (drug)
- Pregnant or breast-feeding woman
- Patient benefiting from legal protection
- 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.
- Status epilepticus (a generalized convulsive seizure lasting more than 5 minutes or a focal seizure with impaired awareness lasting more than 10 minutes) occurring before the second seizure that would otherwise define the cluster. In this situation, management should follow the treatment recommendations for status epilepticus.
- Prolonged impairment of consciousness following the seizure cluster, precluding the safe oral administration of probenecid/placebo tablets.
- Patient who withdrew consent prior to randomization. Patients secondarily excluded will be excluded before randomization and will be replaced.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
Hôpital Fondation A de Rothschild
Paris, 75019
Gilles HUBERFELD, Dr, 0148036584, ghuberfeld@for.paris
Amélie YAVCHITZ, Dr, 01 48 03 64 54, ayavchitz@for.paris
- Not yet recruiting
Hôpital Fondation A de Rothschild
Paris, 75019
Marie Thérèse DANGLES, Dr, 0148036565 ext. 5620, mtdangles@for.paris
Amélie YAVCHITZ, Dr, 01 48 03 64 54, ayavchitz@for.paris
About this study
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
- Being tested
- Probenecid, Placebo
- Medical subject headings
- Epilepsies, Partial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbenecidDrug
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.
PlaceboOther
Placebo administration in a scheme similar to experimental treatment
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Probenecid |
| placebo | Placebo comparator | Placebo administration in a scheme similar to experimental treatment. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Time period from Day 0 to maximum Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study start24 Aug 2026
- Primary completionSep 2029 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focal EpilepsyStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07318870
- Sponsor's protocol ID
- GHD_2024_12
- Acronym
- PROBCLUSTER
- Status last verified
- Sep 2026
- First submitted
- 4 Dec 2025
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Probenecid on Cluster Seizures During Anti Seizure Medication Withdrawal in Presurgical Focal Epilepsy Video-EEG Monitoring
- ClinicalTrials.gov ID
- NCT07318870
- Acronym / sponsor ID
- PROBCLUSTER / GHD_2024_12
- Conditions
- Focal Epilepsy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 24 Aug 2026 (actual)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 6 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| probenecid | Experimental | Drug: ProbenecidOral 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 | Other: PlaceboPlacebo administration in a scheme similar to experimental treatment. |
Who may qualify
- Ages
- 6 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Patients between 6 and 50 years old
- Adults, of any weight, who are free from malnutrition or any condition affecting their physiology to any significant degree; or children/adolescents weigheing more than 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, or without dose reduction in the case of epilepsy whose natural history suggests the appearence of seizures without withdrawal
- Able to take an oral therapy
Key exclusion criteria (15 listed)
- Hypersensitivity to PBN or to any of the excipients (Microcrystalline cellulose, Hypromellose, Sodium carboxymethylamidon, Colloidal anhydrous silica, Magnesium stearate)
- Known or identified impaired renal function (creatinine clearance < 50 mL/min) in children and adults
- Lithiasis diathesis
- Treatment by the following drugs: acetylsalicylic acid, methotrexate (note: the following medications require caution when co-administrated: penicillins, quinolones, cephalosporins including cefadroxil, paracetamol, naproxen, indomethacin, ketoprofen, lorazepam, thiopental, olanzapine, famotidine, clofibrate, valaciclovir, aciclovir, ganciclovir, cidofovir, zidovudine, angiotensin converting enzyme inhibitors and dyprophylline)
- Acute gout attack
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProbenecidOral 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 |
| PlaceboPlacebo administration in a scheme similar to experimental treatment | Other | placebo |
Primary outcome
Cessation of seizure recurrence in patients experiencing a cluster seizure
Time frame: Time period from Day 0 to maximum Day 21
Patients without seizure between 60 min and 12h after experimental treatment administration, assessed by the neurologist on video-EEG recording
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Probenecid in people with Focal Epilepsy, run by Fondation Ophtalmologique Adolphe de Rothschild at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amelie Yavchitz, Dr (+33148036454, ayavchitz@for.paris), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cessation of seizure recurrence in patients experiencing a cluster seizure (time frame: Time period from Day 0 to maximum Day 21). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.