Status:
COMPLETED
A Pilot Study of Topiramate in Childhood Absence Epilepsy
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborating Sponsors:
Ortho-McNeil Neurologics, Inc.
Conditions:
Epilepsy, Absence
Eligibility:
All Genders
4-9 years
Phase:
PHASE2
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 pr...
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2006
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00210574
Start Date
March 1 2005
End Date
October 1 2006
Last Update
June 10 2011
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