Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00361010
Recruitment Status : Completed
First Posted : August 7, 2006
Last Update Posted : July 28, 2011
UCB Pharma
Information provided by:
The Cleveland Clinic

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 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.

Condition or disease Intervention/treatment Phase
Epilepsy Childhood Absence Epilepsy Seizures Drug: Levetiracetam Not Applicable

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 phase where the optimal medication dose will be defined. Absence seizures are often brief and subtle with no postictal manifestations. As a result, clinical observation alone is inadequate to assess the seizure Therefore, both subjective clinical response (parental/caregiver assessment) and EEG recordings are an important part of evaluation of treatment response. A 6 hour outpatient video-EEG study (including 3 minutes of hyperventilation), followed by an 18 hour ambulatory EEG recording - for total 24 hour EEG recording will be done before treatment and every 2 weeks after each dose plateau is reached )

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of Efficacy and Tolerability of Levetiracetam Monotherapy in Subjects With Childhood Absence Epilepsy
Study Start Date : December 2006
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Primary Outcome Measures :
  1. The primary efficacy variable will be change in seizure frequency.

Secondary Outcome Measures :
  1. Determine the design of a larger placebo controlled monotherapy study of the use of levetiracetam for CAE.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   4 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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 Criteria:

  • 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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00361010

Layout table for location information
United States, Ohio
The Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
The Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
UCB Pharma
Layout table for investigator information
Principal Investigator: Deepak K Lachhwani, MD The Cleveland Clinic, Division of Pediatric Neurology

Layout table for additonal information Identifier: NCT00361010     History of Changes
Other Study ID Numbers: KeppraCAE
First Posted: August 7, 2006    Key Record Dates
Last Update Posted: July 28, 2011
Last Verified: July 2011
Keywords provided by The Cleveland Clinic:
Childhood Absence Epilepsy
Additional relevant MeSH terms:
Layout table for MeSH terms
Epilepsy, Absence
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Epilepsy, Generalized
Epileptic Syndromes
Nootropic Agents