A Pilot Study of Efficacy and Tolerability of Levetiracetam Monotherapy in Subjects With Childhood Absence Epilepsy

Completed · Not applicable

Conditions studied: Epilepsy, Childhood Absence Epilepsy, Seizures

In brief

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 baseline. Keppra (levetiracetam) is approved by the U.S. Food and Drug Administration (FDA) to treat partial seizures in adults. It is currently being studied in children with partial seizures. Absence seizures can be difficult to detect clinically, therefore the response to therapy will be determined both by clinical observation and by 24 hour EEG recordings. The researchers hope that with this information they will learn how well it works for the treatment of childhood absence epilepsy and at what dose. This is an open-label, dose-ranging pilot study of levetiracetam in subjects with newly diagnosed childhood absence epilepsy. Approximately 20 patients will be needed to study effectiveness and dose requirements. Subjects must not be on any antiepileptic medication at the time of entry into the study. Male and female subjects from the ages of 4 to 10 years of age may participate.

Key facts

Study ID

NCT00361010

Run by

The Cleveland Clinic

People needed

20

Starts

2006-12-01

Expected to finish

2007-12-01

Last updated by the study team

2011-07-28

Who can join

Age: 4 and older, up to 10. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• The Cleveland Clinic Foundation — Cleveland, Ohio, United States
• The Cleveland Clinic — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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