EpilepsyNCT00851331
Genetic Basis of Idiopathic Focal Epilepsies With Cognitif Deficits
A study testing genome analyzes (genetic defects and pathophysiological mechanisms ) in people with Epilepsy, run by University Hospital, Strasbourg, France at 4 sites in France.
Trial summary
Epilepsy is a frequent neurological disease in childhood, characterized by recurrent seizures and sometimes with major effects on social, behavioral and cognitive development. Childhood focal epilepsies particularly are age-related diseases mainly occurring during developmental critical period. Read more about this study
- Who is it for?
- Ages 4 years and olderHealthy volunteers can take part
- Conditions the study is for
- Epilepsy
- What is being tested?
- genome analyzes (genetic defects and pathophysiological mechanisms )
- How many people
- Not given
- Where
- 4 sitesFrance
- Study dates
- Start not givento not given
- Phase
- Interventional
- 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 4 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- iodiopathic focal epilepsy with cognitif deficit
Who cannot join
- medical history of status epilepticus
Trial locations and contacts
4 sites in 1 country.
France4 sites
Hôpital Femme Mère Enfant - Hospices Civils de Lyon, Service Epilepsie, Sommeil et Exploration fonctionnelle neurologique pédiatrique
Bron, 69500
American Memorial Hospital, CHU de Reims, Unité de Neurologie Pédiatrique - Service Pédiatrie A
Reims, 51092
Clinique neurologique, Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
Hôpital de Hautepierre, Service de pédiatrie 1
Strasbourg, 67098
About this study
Epilepsy is a frequent neurological disease in childhood, characterized by recurrent seizures and sometimes with major effects on social, behavioral and cognitive development. Childhood focal epilepsies particularly are age-related diseases mainly occurring during developmental critical period. A complex interplay between brain development and maturation processes and susceptibility genes may contribute to the development of various childhood epileptic syndromes associated with language and cognitive deficits. Indeed, the Landau-Kleffner syndrome (LKS), the continuous spike-and-waves during sleep syndrome (CSWS), and the benign childhood epilepsy with centrotemporal spikes (BCECTS) or benign rolandic epilepsy, are different syndromes that are considered as part of a single continuous spectrum of disorders. While genetic component in those three syndromes remains elusive, novel and high throughput genome analyzes could bring interesting insights into the possible genetic defects and pathophysiological mechanisms underlying and linking the various disorders associating epilepsy with speech and cognitive impairments.
- Conditions
- Epilepsy
- Being tested
- genome analyzes (genetic defects and pathophysiological mechanisms )
- Keywords
- Benign childhood epilepsy
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
genome analyzes (genetic defects and pathophysiological mechanisms )Genetic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Interventional
- Phase
- Phase N/A
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Investigators
- Edouard HIRSCH, MD, Principal investigator, University Hospital, Strasbourg, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00851331
- Sponsor's protocol ID
- 3391
- Status last verified
- Feb 2009
- First submitted
- 24 Feb 2009
- Last updated
- 25 Feb 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Basis of Idiopathic Focal Epilepsies With Cognitif Deficits
- ClinicalTrials.gov ID
- NCT00851331
- Acronym / sponsor ID
- 3391
- Conditions
- Epilepsy
- Keywords
- Benign childhood epilepsy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- First posted
- 25 Feb 2009 (estimated)
- 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.
Epilepsy is a frequent neurological disease in childhood, characterized by recurrent seizures and sometimes with major effects on social, behavioral and cognitive development. Childhood focal epilepsies particularly are age-related diseases mainly occurring during developmental critical period. A complex interplay between brain development and maturation processes and susceptibility genes may contribute to the development of various childhood epileptic syndromes associated with language and cognitive deficits. Indeed, the Landau-Kleffner syndrome (LKS), the continuous spike-and-waves during sleep syndrome (CSWS), and the benign childhood epilepsy with centrotemporal spikes (BCECTS) or benign rolandic epilepsy, are different syndromes that are considered as part of a single continuous spectrum of disorders. While genetic component in those three syndromes remains elusive, novel and high throughput genome analyzes could bring interesting insights into the possible genetic defects and pathophysiological mechanisms underlying and linking the various disorders associating epilepsy with speech and cognitive impairments.
Study design
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- iodiopathic focal epilepsy with cognitif deficit
Key exclusion criteria (1 listed)
- medical history of status epilepticus
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 |
|---|---|---|
| genome analyzes (genetic defects and pathophysiological mechanisms ) | Genetic | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2009.
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Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
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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.
Edouard HIRSCH, MD principal investigator
University Hospital, Strasbourg, France
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing genome analyzes (genetic defects and pathophysiological mechanisms ) in people with Epilepsy, run by University Hospital, Strasbourg, France at 4 sites 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 25 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gabrielle Rudolf, PhD, HDR ((33) 3.88.11.66.62 ext. 3207, Gabrielle.Rudolf@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 25 Feb 2009.