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

Primary Purpose

Epilepsy, Childhood Absence Epilepsy, Seizures

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Levetiracetam
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy focused on measuring Keppra, Epilepsy, Childhood Absence Epilepsy, Seizures

Eligibility Criteria

4 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Cleveland Clinic Foundation
  • The Cleveland Clinic

Outcomes

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.

Full Information

First Posted
August 3, 2006
Last Updated
July 27, 2011
Sponsor
The Cleveland Clinic
Collaborators
UCB Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT00361010
Brief Title
A Pilot Study of Efficacy and Tolerability of Levetiracetam Monotherapy in Subjects With Childhood Absence Epilepsy
Official Title
A Pilot Study of Efficacy and Tolerability of Levetiracetam Monotherapy in Subjects With Childhood Absence Epilepsy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
The Cleveland Clinic
Collaborators
UCB Pharma

4. Oversight

5. Study Description

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.
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 )

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy, Childhood Absence Epilepsy, Seizures
Keywords
Keppra, Epilepsy, Childhood Absence Epilepsy, Seizures

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Levetiracetam
Primary Outcome Measure Information:
Title
The primary efficacy variable will be change in seizure frequency.
Secondary Outcome Measure Information:
Title
Determine the design of a larger placebo controlled monotherapy study of the use of levetiracetam for CAE.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deepak K Lachhwani, MD
Organizational Affiliation
The Cleveland Clinic, Division of Pediatric Neurology
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
The Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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