EpilepsyNCT00282854
Genetics of Rolandic Epilepsy
An observational study of Epilepsy, run by King's College London at 1 site in United States.
Trial summary
The purpose of this study is to find the genes that cause Rolandic epilepsy and its related traits. Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Epilepsy
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to Dec 2013
- 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 3 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Community Sample
Who may be able to join
- typical history of focal seizures
- EEG centrotemporal sharp waves
- age of onset 3-12 years
- no previous epilepsy type (febrile seizures OK)
- normal development
- normal neurological examination
- normal MRI/CT (if done)
Who cannot join
- only history of secondary generalized seizures
- atypical history/semiology
- history and EEG inconsistent
- abnormal EEG background
- very early (<3yrs) or late (>12yrs) onset
- global neurodevelopmental deficit
- deviant neurodevelopment
- structural imaging abnormality
Trial locations and contacts
1 site in 1 country.
United States1 site
Mailman School of Public Health, Columbia University Medical Center, 722 West 168th St, 6th Floor
New York, New York, 10032
About this study
The purpose of this study is to find the genes that cause Rolandic epilepsy and its related traits.
Read the detailed description
Rolandic epilepsy (RE) is the most common type of childhood epilepsy-affecting more than 50,000 children in the United States-and has a complex genetic inheritance. The seizure prognosis is relatively benign, however, many children with RE also have problems with speech and language, reading, and motor coordination. Symptoms of the disorder overlap with more severe types of epilepsy.
The purpose of this study is to find the genes that influence RE and its related traits. Identifying genetic causes for the variants would improve diagnosis and allow for early intervention.
Researchers will enroll 1000 children with RE and 3000 controls for participation in the study. The scientists will request medical histories and (salivary) DNA samples from the participants. Participation can be completed by mail and telephone.
Results from this study should provide important information regarding diagnosis and prognosis of RE, may be useful in clinical management, and, eventually, may lead to a cure for this and other forms of epilepsy.
- Conditions
- Epilepsy
- Keywords
- epilepsy, Rolandic epilepsy
- Medical subject headings
- Epilepsy, Epilepsy, Rolandic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group I: Cases | Children with rolandic epilepsy | |
| Group II: Controls | Individuals group matched to cases for ethnicity, sex and area of residence but lacking a primary brain disorder. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2006 (estimated)
- Study startJan 2005
- Primary completionDec 2013
- Study completionDec 2013
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 King's College LondonThe 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Deb K. Pal, MD, PhD, Principal investigator, Associate Research Scientist, Mailman School of Public Health, Columbia University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00282854
- Sponsor's protocol ID
- 4727
- Other IDs
- R01NS047530
- Status last verified
- Aug 2011
- First submitted
- 26 Jan 2006
- Last updated
- 28 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetics of Rolandic Epilepsy
- ClinicalTrials.gov ID
- NCT00282854
- Acronym / sponsor ID
- 4727
- Conditions
- Epilepsy
- Keywords
- epilepsy, Rolandic epilepsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- Jan 2005
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 27 Jan 2006 (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.
The purpose of this study is to find the genes that cause Rolandic epilepsy and its related traits.
Detailed description
Rolandic epilepsy (RE) is the most common type of childhood epilepsy-affecting more than 50,000 children in the United States-and has a complex genetic inheritance. The seizure prognosis is relatively benign, however, many children with RE also have problems with speech and language, reading, and motor coordination. Symptoms of the disorder overlap with more severe types of epilepsy.
The purpose of this study is to find the genes that influence RE and its related traits. Identifying genetic causes for the variants would improve diagnosis and allow for early intervention.
Researchers will enroll 1000 children with RE and 3000 controls for participation in the study. The scientists will request medical histories and (salivary) DNA samples from the participants. Participation can be completed by mail and telephone.
Results from this study should provide important information regarding diagnosis and prognosis of RE, may be useful in clinical management, and, eventually, may lead to a cure for this and other forms of epilepsy.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I: Cases | – | –Children with rolandic epilepsy |
| Group II: Controls | – | –Individuals group matched to cases for ethnicity, sex and area of residence but lacking a primary brain disorder. |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Community Sample
Key inclusion criteria (7 listed)
- typical history of focal seizures
- EEG centrotemporal sharp waves
- age of onset 3-12 years
- no previous epilepsy type (febrile seizures OK)
- normal development
Key exclusion criteria (8 listed)
- only history of secondary generalized seizures
- atypical history/semiology
- history and EEG inconsistent
- abnormal EEG background
- very early (<3yrs) or late (>12yrs) onset
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 28 Jun 2023.
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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.
Deb K. Pal, MD, PhD principal investigator
Associate Research Scientist, Mailman School of Public Health, Columbia University Medical Center
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 Epilepsy, run by King's College London at 1 site in United States.
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 7 inclusion and 8 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 28 Jun 2023. 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 United States. 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.
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 28 Jun 2023.