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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04048213
Other study ID # PI2018_843_0058
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 1, 2019
Est. completion date December 2023

Study information

Verified date April 2023
Source Centre Hospitalier Universitaire, Amiens
Contact Patrick Berquin, Pr
Phone (33)30322087670
Email berquin.patrick@chu-amiens.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Doose syndrome is a rare epileptic syndrome that can lead to learning difficulties and a poor quality of life. The goal of this study is to evaluate the evolution of epilepsy and its consequences on cognitive development and learning issues in children with Doose syndrome.


Description:

Doose syndrome is a rare epileptic syndrome beginning between ages two and five, characterized by myoclonic-astatic seizures which can be associated with myoclonic seizures, astatic seizures, absences and generalized tonic-clonic seizures. These seizures can be difficult to treat effectively and may lead to learning difficulties. During this study, parents of children with Doose syndrome will receive a questionnaire regarding learning disabilities, quality of life and epilepsy of their children.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date December 2023
Est. primary completion date December 2023
Accepts healthy volunteers No
Gender All
Age group 1 Year to 6 Years
Eligibility Inclusion Criteria: - children with doose syndrome diagnosed between ages 1 and 6 - normal development until onset of seizures Exclusion Criteria: - unconfirmed diagnoses - abnormal diagnoses - abnormal psychomotor development before onset of seizures - cerebral MRI abnormalities - other child epileptic syndromes

Study Design


Intervention

Other:
questionnaire
questionnaire send to the parents

Locations

Country Name City State
France CHU Amiens Amiens

Sponsors (3)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire, Amiens University Hospital, Lille, University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary disease effects on the learning ability of children with doose syndrome disease effects on the learning ability of children with doose syndrome base on scholar informations day of inclusion
Secondary Evolution of epilepsy in children with doose syndrome based on pathological symptoms Evolution of epilepsy in children with doose syndrome based on pathological symptoms day of inclusion
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