NCT00282854

Brief Summary

The purpose of this study is to find the genes that cause Rolandic epilepsy and its related traits.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 26, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 27, 2006

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

June 28, 2023

Status Verified

August 1, 2011

Enrollment Period

8.9 years

First QC Date

January 26, 2006

Last Update Submit

June 26, 2023

Conditions

Epilepsy

Keywords

epilepsyRolandic epilepsy

Study Arms (2)

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.

Eligibility Criteria

Age3 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Community Sample

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mailman School of Public Health, Columbia University Medical Center, 722 West 168th St, 6th Floor

New York, New York, 10032, United States

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

whole blood

MeSH Terms

Conditions

EpilepsyEpilepsy, Rolandic

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesEpilepsies, PartialEpileptic Syndromes

Study Officials

  • Deb K. Pal, MD, PhD

    Associate Research Scientist, Mailman School of Public Health, Columbia University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2006

First Posted

January 27, 2006

Study Start

January 1, 2005

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

June 28, 2023

Record last verified: 2011-08

Locations

US(1)