Skip to main content
OpenTrials
Completed

NCT Number: NCT00361010

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Childhood Absence Epilepsy Epilepsy, Absence Epilepsy, Generalized Epileptic Syndromes Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Seizures Signs and Symptoms

Age range

4 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Cleveland Clinic, Cleveland, Ohio, United States

Loading trial locations.

About this study

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 )

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Levetiracetam

Drug

Primary outcomes

  1. The primary efficacy variable will be change in seizure frequency.

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Collaborators

  • UCB Pharma

Registry information

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Aug 7, 2006
Registry last updated
Jul 28, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.