NCT02821260

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
27mo left

Started Dec 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress83%
Dec 2015Sep 2028

Study Start

First participant enrolled

December 1, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 29, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 1, 2016

Completed
12.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2028

Last Updated

July 11, 2023

Status Verified

July 1, 2023

Enrollment Period

12.8 years

First QC Date

June 29, 2016

Last Update Submit

July 10, 2023

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (1)

  • Number of seizures

    Three years

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pediatric epilepsy requiring surgical treatment

You may qualify if:

  • Child treated surgically for epilepsy at the Rothschild Foundation (Paris, France)

You may not qualify if:

  • Parental opposition to the participation of their child to the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondation Ophtalmologique Adolphe de Rothschild

Paris, France

RECRUITING

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Central Study Contacts

Christine BULTEAU, MD

CONTACT

cbulteau@fo-rothschild.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2016

First Posted

July 1, 2016

Study Start

December 1, 2015

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

September 1, 2028

Last Updated

July 11, 2023

Record last verified: 2023-07

Locations

FR(1)