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| Tracking Information | |||||
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| First Received Date ICMJE | July 19, 2002 | ||||
| Last Updated Date | May 21, 2009 | ||||
| Start Date ICMJE | December 1998 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00041951 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Search for Genes Influencing Childhood Absence Epilepsy Study | ||||
| Official Title ICMJE | Search for Genes Influencing Childhood Absence Epilepsy Study | ||||
| Brief Summary | The purpose of our study is to identify gene(s) involved in the cause of childhood absence epilepsy (CAE). |
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| Detailed 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. Investigating whole families with many members affected with epilepsy or both parents and a child with CAE of families without other affected members (trios) and 2. comparing patients with CAE to healthy individuals without epilepsy. Participation in this study requires an interview regarding medical and family history and blood drawing or saliva collection from all available family members of families with many epilepsy cases. Parents and children with absence from families without a family history of seizures are asked to provide a small amount of saliva (spit) only. Healthy volunteers without epilepsy or a family history of seizures are asked 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, blood tests can be arranged at locations elsewhere at no cost to participants or their insurance. Researchers will also travel to subject's home. For the collection of saliva, special containers are provided and can be shipped by mail. 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. |
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| Study Phase | |||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Case Control, Prospective | ||||
| Condition ICMJE |
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| Intervention ICMJE | |||||
| Study Arms / Comparison Groups |
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| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 1000 | ||||
| Estimated Completion Date | March 2010 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Patients with classical (typical) Childhood Absence Epilepsy and their families. |
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| Gender | Both | ||||
| Ages | |||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00041951 | ||||
| Responsible Party | Martina Durner, MD, Associate Professor of Psychiatry, Mount Sinai School of Medicine | ||||
| Study ID Numbers ICMJE | R01NS37466 | ||||
| Study Sponsor ICMJE | Mount Sinai School of Medicine | ||||
| Collaborators ICMJE | National Institute of Neurological Disorders and Stroke (NINDS) | ||||
| Investigators ICMJE |
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| Information Provided By | Mount Sinai School of Medicine | ||||
| Verification Date | October 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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