EpilepsyPEPSINCT02821260
Clinical Evaluation of the Efficacity of Epilepsy Surgery in Infants and Children
An observational study of Epilepsy, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial summary
The Pediatric Neurosurgery Service of the Rothschild Foundation (Paris) is the French leader center for surgery of epilepsy in infants and children. Postoperative follow-up of these children is performed during medical and neurosurgical consultations in order to assess the frequency of attacks and to reduce… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Epilepsy
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2015to Sep 2028
- Phase
- Observational
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric epilepsy requiring surgical treatment
Who may be able to join
- Child treated surgically for epilepsy at the Rothschild Foundation (Paris, France)
Who cannot join
- Parental opposition to the participation of their child to the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Christine BULTEAU, MD contact
France1 site, 1 recruiting
- Recruiting
Fondation Ophtalmologique Adolphe de Rothschild
Paris
Laurence SALOMON, MD
About this study
The Pediatric Neurosurgery Service of the Rothschild Foundation (Paris) is the French leader center for surgery of epilepsy in infants and children.
Postoperative follow-up of these children is performed during medical and neurosurgical consultations in order to assess the frequency of attacks and to reduce medication.
Read more
On average, two postoperative consultations are carried out between 3 and 5 months and between 12 and 18 months. Beyond 18 months, some children may benefit from long-term monitoring at this center, but most children are followed by their neurologist .
Therefore, the center has no rigorous and systematic collection of standardized data on the outcome of these patients.
The purpose of this study is to evaluate the efficacy of the epilepsy surgery in children with a monitoring of 3 years.
- Conditions
- Epilepsy
- Medical subject headings
- Epilepsy
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of seizures
Measured: Three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2016 (estimated)
- Study startDec 2015
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 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
- NCT02821260
- Sponsor's protocol ID
- CBU_2015_29
- Acronym
- PEPSI
- Status last verified
- Jul 2023
- First submitted
- 29 Jun 2016
- Last updated
- 11 Jul 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Efficacity of Epilepsy Surgery in Infants and Children
- ClinicalTrials.gov ID
- NCT02821260
- Acronym / sponsor ID
- PEPSI / CBU_2015_29
- Conditions
- Epilepsy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- Dec 2015 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 1 Jul 2016 (estimated)
- 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.
The Pediatric Neurosurgery Service of the Rothschild Foundation (Paris) is the French leader center for surgery of epilepsy in infants and children.
Postoperative follow-up of these children is performed during medical and neurosurgical consultations in order to assess the frequency of attacks and to reduce medication.
On average, two postoperative consultations are carried out between 3 and 5 months and between 12 and 18 months. Beyond 18 months, some children may benefit from long-term monitoring at this center, but most children are followed by their neurologist .
Therefore, the center has no rigorous and systematic collection of standardized data on the outcome of these patients.
The purpose of this study is to evaluate the efficacy of the epilepsy surgery in children with a monitoring of 3 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric epilepsy requiring surgical treatment
Key inclusion criteria (1 listed)
- Child treated surgically for epilepsy at the Rothschild Foundation (Paris, France)
Key exclusion criteria (1 listed)
- Parental opposition to the participation of their child to the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of seizures
Time frame: Three years
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 11 Jul 2023.
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Epilepsy
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.
Christine BULTEAU, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site 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 1 inclusion and 1 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 11 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Christine BULTEAU, MD (cbulteau@fo-rothschild.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of seizures (time frame: Three years). 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 11 Jul 2023; AzTrials last refreshed its copy on 8 Nov 2026.