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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00041951
Other study ID # GCO 07-1441
Secondary ID R01NS037466
Status Completed
Phase N/A
First received July 19, 2002
Last updated May 31, 2016
Start date December 1998
Est. completion date July 2014

Study information

Verified date May 2016
Source Icahn School of Medicine at Mount Sinai
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

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


Description:

A high familial predisposition for epilepsy in patients with childhood absence epilepsy (CAE), also called petit mal epilepsy, suggests underlying genetic causes contributing to the disease. Several areas harboring potential absence epilepsy genes have been identified in the genome.

This study will further narrow down those areas and identify gene(s) involved in the cause of CAE by taking several approaches: 1. Comparing patients with CAE to healthy individuals without epilepsy and 2. Investigating whole families with many members affected with epilepsy).

Participation in this study requires an interview regarding medical and family history and saliva (spit) collection from all available family members of families with many epilepsy cases. For those families without a history of epilepsy, parents and children are asked to provide a small amount of saliva only. Healthy volunteers without epilepsy or a family history of seizures are asked to fill out an anonymous questionnaire and provide a small amount of saliva as well.

Although the study is based at Mount Sinai School of Medicine in New York, all study materials can be sent to your home at no cost to participants or their insurance. For the collection of saliva, special containers are provided and they can be shipped back to Mount Sinai in the pre-paid envelope provided. Study materials can be completed at your convenience.

Results from this study may enable scientists to understand the cause of absence seizures and, perhaps, other types of seizures as well and with this laying the foundation for better diagnosis and treatment of epilepsy patients in the future.


Recruitment information / eligibility

Status Completed
Enrollment 185
Est. completion date July 2014
Est. primary completion date July 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 3 Years and older
Eligibility Patients and their families:

Inclusion Criteria:

- Clinical diagnosis of classical (typical) Childhood Absence Epilepsy

- Good seizure control

- Must be able to give saliva sample

Exclusion Criteria:

- History of non-febrile seizures prior to the onset of typical absence seizures

- other neuropsychiatric or developmental disorders.

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Locations

Country Name City State
United States Icahn School of Medicine at Mount Sinai New York New York

Sponsors (2)

Lead Sponsor Collaborator
Icahn School of Medicine at Mount Sinai National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Saliva sample at baseline No
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