Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00210574
Status:
COMPLETED
Last Update Posted:
2011-06-10
First Post:
2005-09-13
Brief Title:
A Pilot Study of Topiramate in Childhood Absence Epilepsy
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
A Pilot Study of Topiramate in Childhood Absence Epilepsy
Status:
COMPLETED
Status Verified Date:
2010-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Limited data exist on the effectiveness of antiepileptic drugs for treatment of childhood absence epilepsy Preliminary data suggest that topiramate may be an effective drug for this condition The present study is designed to provide further evidence of the potential effectiveness of topiramate for childhood absence epilepsy as well as preliminary information about a potential target dose for future study
Detailed Description:
Childhood Absence Epilepsy CAE affects 2-11 of all children with epilepsy CAE occurs most frequently in children between the ages of 4 and 10 years Children with CAE have brief seizures usually several seconds in duration that typically involve staring and loss of awareness twitching movement of the face or other areas of the body may also occur Absence seizures are provoked by deep breathing for several minutes hyperventilation Topiramate is known to be effective in several types of seizures in children Preliminary data from studies on other types of epilepsy as well as case reports suggest that it may also be effective in the type of seizures that occur in CAE The objective of the study is to gather additional preliminary data on the effectiveness and the potential target dose of topiramate in CAE Because CAE is not expected to resolve spontaneously in the age group being studied no control group will be included Patients in the study will receive increasing doses of topiramate with the starting dose and dose increases at weekly intervals The starting dose and dosage increases will be based on the childs weight At each visit hyperventilation will be used to determine if seizures can be provoked If seizures occur the dose will be further increased to the maximum dose for the study If seizures do not occur with hyperventilation an electroencephalogram EEG will be performed to confirm that the seizures are not occurring If the EEG confirms that no seizures are occurring topiramate dose will be maintained for 12 weeks Topiramate will be given in the form of sprinkles contained within capsules that may be opened and the drug sprinkled onto food Starting dose will depend on the childs weight then increased to a maximum dose 9 milligramskilogramday or 400 milligramsday whichever is less for up to 162 days
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None