NCT04048213

Brief 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.

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
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2019

Longer than P75 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2019

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

August 6, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 7, 2019

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

April 12, 2023

Status Verified

April 1, 2023

Enrollment Period

4.3 years

First QC Date

August 6, 2019

Last Update Submit

April 11, 2023

Conditions

Keywords

doose syndromeEpileptic SyndromesLearning Disabilities

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Evolution of epilepsy in children with doose syndrome based on pathological symptoms

    day of inclusion

Interventions

questionnaire send to the parents

Eligibility Criteria

Age1 Year - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

During this study, parents of children with Doose syndrome will receive a questionnaire regarding learning disabilities, quality of life and epilepsy of their children. Children with doose syndrome diagnosed between ages 1 and 6 and with normal development until onset of seizures will be included in this study.

You may qualify if:

  • children with doose syndrome diagnosed between ages 1 and 6
  • normal development until onset of seizures

You may not qualify if:

  • unconfirmed diagnoses
  • abnormal diagnoses
  • abnormal psychomotor development before onset of seizures
  • cerebral MRI abnormalities
  • other child epileptic syndromes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens

Amiens, 80480, France

RECRUITING

MeSH Terms

Conditions

Epilepsies, MyoclonicEpileptic SyndromesLearning Disabilities

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Epilepsy, GeneralizedEpilepsyBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Sylvie Nguyen, Pr

    CHRU LILLE

    PRINCIPAL INVESTIGATOR
  • Axel Lebas, MD

    CHU Rouen

    PRINCIPAL INVESTIGATOR

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

August 6, 2019

First Posted

August 7, 2019

Study Start

August 1, 2019

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

April 12, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations