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Trial record 2 of 7 for:    "Epilepsy Juvenile Absence"
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A Pilot Study of Efficacy and Tolerability of Levetiracetam Monotherapy in Subjects With Childhood Absence Epilepsy

This study has been completed.
Sponsor:
Collaborator:
UCB, Inc.
Information provided by:
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00361010
First received: August 3, 2006
Last updated: July 27, 2011
Last verified: July 2011
History of Changes
  Purpose

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 Intervention
Epilepsy
Childhood Absence Epilepsy
Seizures
 Drug: Levetiracetam

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study of Efficacy and Tolerability of Levetiracetam Monotherapy in Subjects With Childhood Absence Epilepsy

Resource links provided by NLM:

MedlinePlus related topics: Epilepsy Seizures
U.S. FDA Resources

Further study details as provided by The Cleveland Clinic:

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

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

Estimated Enrollment: 20
Study Start Date: December 2006
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
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 )

  Eligibility

Ages Eligible for Study:   4 Years to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00361010

Locations
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, Inc.
Investigators
Principal Investigator: Deepak K Lachhwani, MD The Cleveland Clinic, Division of Pediatric Neurology
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00361010     History of Changes
Other Study ID Numbers: KeppraCAE
Study First Received: August 3, 2006
Last Updated: July 27, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by The Cleveland Clinic:
Keppra
Epilepsy
Childhood Absence Epilepsy
Seizures

Additional relevant MeSH terms:
Epilepsy
Epilepsy, Absence
Seizures
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Epilepsy, Generalized
Neurologic Manifestations
Signs and Symptoms
Etiracetam
 Piracetam
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Nootropic Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 18, 2013