Doose SyndromeDOOSENCT04048213
The Becoming of Children With Doose Syndrome
An observational study of Doose Syndrome and Epileptic Syndromes, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 1 year to 6 years
- Conditions the study is for
- Doose Syndrome, Epileptic Syndromes, Learning Disabilities
- What is being tested?
- questionnaire
- How many people
- 9 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2019to 27 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 6 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- children with doose syndrome diagnosed between ages 1 and 6
- normal development until onset of seizures
Who cannot join
- unconfirmed diagnoses
- abnormal diagnoses
- abnormal psychomotor development before onset of seizures
- cerebral MRI abnormalities
- other child epileptic syndromes
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Conditions
- Doose Syndrome, Epileptic Syndromes, Learning Disabilities
- Being tested
- questionnaire
- Keywords
- doose syndrome, Epileptic Syndromes, Learning Disabilities
- Medical subject headings
- Epilepsies, Myoclonic, Epileptic Syndromes, Learning Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaireOther
questionnaire send to the parents
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: day of inclusion
Secondary outcomes (1)
Evolution of epilepsy in children with doose syndrome based on pathological symptoms
Evolution of epilepsy in children with doose syndrome based on pathological symptoms
Measured: day of inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2019
- Study start1 Jun 2019
- Primary completion27 Jun 2023
- Study completion27 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Doose SyndromeStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Lille, University Hospital, Rouen
- Responsible party
- Sponsor
- Investigators
- Sylvie Nguyen, Pr, Principal investigator, CHRU LILLEAxel Lebas, MD, Principal investigator, CHU Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04048213
- Sponsor's protocol ID
- PI2018_843_0058
- Acronym
- DOOSE
- Status last verified
- Jun 2026
- First submitted
- 6 Aug 2019
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Becoming of Children With Doose Syndrome
- ClinicalTrials.gov ID
- NCT04048213
- Acronym / sponsor ID
- DOOSE / PI2018_843_0058
- Conditions
- Doose Syndrome, Epileptic Syndromes, Learning Disabilities
- Keywords
- doose syndrome, Epileptic Syndromes, Learning Disabilities
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Collaborators
- University Hospital, Lille, University Hospital, Rouen
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 27 Jun 2023 (actual)
- Study completion
- 27 Jun 2023 (actual)
- First posted
- 7 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (2 listed)
- children with doose syndrome diagnosed between ages 1 and 6
- normal development until onset of seizures
Key exclusion criteria (5 listed)
- unconfirmed diagnoses
- abnormal diagnoses
- abnormal psychomotor development before onset of seizures
- cerebral MRI abnormalities
- other child epileptic syndromes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnairequestionnaire send to the parents | Other | – |
Primary outcome
disease effects on the learning ability of children with doose syndrome
Time frame: day of inclusion
disease effects on the learning ability of children with doose syndrome base on scholar informations
1 secondary outcome
Evolution of epilepsy in children with doose syndrome based on pathological symptoms
Time frame: day of inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sylvie Nguyen, Pr principal investigator
CHRU LILLE
Axel Lebas, MD principal investigator
CHU Rouen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Doose Syndrome and Epileptic Syndromes, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
disease effects on the learning ability of children with doose syndrome (time frame: day of inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.