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NCT02821260 Clinical Trial

Clinical Evaluation of the Efficacity of Epilepsy Surgery in Infants and Children

Epilepsy Clinical Trial

— PEPSI  

Official title:
Clinical Evaluation of the Efficacity of Epilepsy Surgery in Infants and Children

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02821260
Other study ID # CBU_2015_29
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 2015
Est. completion date September 2028

Study information
Verified date July 2023
Source Fondation Ophtalmologique Adolphe de Rothschild
Contact Christine BULTEAU, MD
Email cbulteau@fo-rothschild.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 500
Est. completion date September 2028
Est. primary completion date September 2028
Accepts healthy volunteers No
Gender All
Age group N/A to 18 Years
Eligibility Inclusion Criteria: - Child treated surgically for epilepsy at the Rothschild Foundation (Paris, France) Exclusion Criteria: - Parental opposition to the participation of their child to the study

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France Fondation Ophtalmologique Adolphe de Rothschild Paris

Sponsors (1)
Lead Sponsor Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of seizures Three years
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