NCT00041951

Brief Summary

The purpose of our study is to identify gene(s) involved in the cause of childhood absence epilepsy (CAE).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
185

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 1998

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

December 1, 1998

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

July 19, 2002

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 22, 2002

Completed
12 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

June 1, 2016

Status Verified

May 1, 2016

Enrollment Period

15.6 years

First QC Date

July 19, 2002

Last Update Submit

May 31, 2016

Conditions

Childhood Absence EpilepsyEpilepsySeizures

Keywords

Childhood Absence EpilepsyCAEPetit MalEpilepsySeizuresGenesInheritanceGeneticsGenetic Linkage

Outcome Measures

Primary Outcomes (1)

  • Saliva sample

    at baseline

Study Arms (2)

CAE participants

Both parents and a child with CAE of families without other affected members (trios) or whole families with many members affected with epilepsy.

Controls

Healthy individuals without epilepsy and no family history of epilepsy.

Eligibility Criteria

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

Whole families with many members affected with epilepsy or both parents and a child with CAE of families without other affected members (trios) and healthy individuals without epilepsy

You may qualify if:

  • Clinical diagnosis of classical (typical) Childhood Absence Epilepsy
  • Good seizure control
  • Must be able to give saliva sample

You may not qualify if:

  • History of non-febrile seizures prior to the onset of typical absence seizures
  • other neuropsychiatric or developmental disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

saliva

MeSH Terms

Conditions

Epilepsy, AbsenceEpilepsySeizures

Condition Hierarchy (Ancestors)

Epilepsy, GeneralizedBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEpileptic SyndromesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Martina Durner, M.D.

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 19, 2002

First Posted

July 22, 2002

Study Start

December 1, 1998

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

June 1, 2016

Record last verified: 2016-05

Locations

US(1)