NCT05455333

Brief Summary

To determine the paraclinical and therapeutic interest of genetic diagnosis in early onset epilepsy.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 7, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 13, 2022

Completed
19 days until next milestone

Study Start

First participant enrolled

August 1, 2022

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

August 12, 2022

Status Verified

August 1, 2022

Enrollment Period

Same day

First QC Date

July 7, 2022

Last Update Submit

August 11, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Measurement of event densities

    The frequency of events (crises, going to the emergency room, hospitalizations) before and after genetic diagnosis.

    4 month

Interventions

Sends and returns questionnaires to families.

Eligibility Criteria

AgeUp to 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children aged ≤ 12 years, hospitalized or followed at the Hautepierre Hospital of the University Hospitals of Strasbourg for primary epilepsy having started in the first 5 months of life, from 2010 to 2021.

You may qualify if:

  • Children aged ≤ 12 years,
  • hospitalized or followed at the Hautepierre Hospital of the University Hospitals of Strasbourg for primary epilepsy having started in the first 5 months of life, from 2010 to 2021.

You may not qualify if:

  • \- Children with secondary epilepsy (with infection trauma)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Génétique Médicale IGMA - Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

Location

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

July 7, 2022

First Posted

July 13, 2022

Study Start

August 1, 2022

Primary Completion

August 1, 2022

Study Completion

December 1, 2022

Last Updated

August 12, 2022

Record last verified: 2022-08

Locations