A Pilot Study of Topiramate in Childhood Absence Epilepsy
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|ClinicalTrials.gov Identifier: NCT00210574|
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : June 10, 2011
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|Condition or disease||Intervention/treatment||Phase|
|Epilepsy, Absence||Drug: topiramate||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of Topiramate in Childhood Absence Epilepsy|
|Study Start Date :||March 2005|
|Actual Study Completion Date :||October 2006|
- Proportion of subjects who become seizure-free.
- Change in number of seizures per hour; change in duration of EEG spike wave discharges per hour; relationship between the lack of seizures and the blood level of topiramate.
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|Ages Eligible for Study:||4 Years to 9 Years (Child)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Weight of at least 15 kg (33 pounds)
- confirmed diagnosis of childhood absence epilepsy
- no other serious health problems or neurologic problems
- have not taken anti-epilepsy drugs other than ethosuximide, lamotrigine, or valproate
- able to take oral medication in a sprinkle capsule formulation
- girls must not have gotten their first menstrual period.
- No seizures that are caused by something other than childhood absence epilepsy
- not taken topiramate, primidone, zonisamide, or phenobarbital in the past
- had to stop taking an anti-epilepsy drug (ethosuximide, lamotrigine, or valproate) because it was not effective in treating childhood absence epilepsy
- no presence of abnormal brain waves on electroencephalogram
- no presence of mental retardation, no autism, or severe developmental disorder.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00210574
|Study Director:||Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial||Johnson & Johnson Pharmaceutical Research & Development, L.L.C.|
|Other Study ID Numbers:||
|First Posted:||September 21, 2005 Key Record Dates|
|Last Update Posted:||June 10, 2011|
|Last Verified:||April 2010|
childhood absence epilepsy
Central Nervous System Diseases
Nervous System Diseases
Physiological Effects of Drugs