Status:
COMPLETED
A Pilot Study of Efficacy and Tolerability of Levetiracetam Monotherapy in Subjects With Childhood Absence Epilepsy
Lead Sponsor:
The Cleveland Clinic
Collaborating Sponsors:
UCB Pharma
Conditions:
Epilepsy
Childhood Absence Epilepsy
Eligibility:
All Genders
4-10 years
Phase:
NA
Brief Summary
Childhood absence epilepsy (CAE) is a form of generalized epilepsy syndrome. Clinically these seizures are manifest with a sudden, brief (3-15 second) loss of awareness followed by a quick recovery to...
Detailed Description
This is a 12 week ( 12 week treatment phase), dose ranging pilot study on the effectiveness of levetiracetam for the treatment of childhood absence epilepsy. It consists of 1 phase. The treatment phas...
Eligibility Criteria
Inclusion
- CAE by EEG criteria
- Naive to antiepileptics
- Onset 3 to 10 years old
- A history of daily seizures
- Age between 4 and 10
- Weight at least 5th percentile for age
- Be able to take oral medications
- Be willing to return for diagnostic testing and visits and adhere to medication regime
Exclusion
- An EEG with any of the following abnormalities
- Focal epilepsy
- Slow spike and wave discharges
- Photoconvulsive response
- Slow background rhythms for age
- Currently being treated with an antiepileptic drug (AED)
- History of MR
- A history of myoclonic, atonic,tonic or astatic seizures
- A clinically unstable disease
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2007
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00361010
Start Date
December 1 2006
End Date
December 1 2007
Last Update
July 28 2011
Active Locations (2)
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1
The Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
2
The Cleveland Clinic
Cleveland, Ohio, United States, 44195