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

Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00361010
• Other study ID #: KeppraCAE
• Status: Completed
• Phase: N/A
• First received: August 3, 2006
• Last updated: July 27, 2011
• Start date: December 2006
• Est. completion date: December 2007

Study information

• Verified date: July 2011
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 )

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 10 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Childhood Absence Epilepsy
• Epilepsy
• Epilepsy, Absence
• Seizures

Intervention

Drug:
• Levetiracetam

Locations

Country	Name	City	State
United States	The Cleveland Clinic	Cleveland	Ohio
United States	The Cleveland Clinic Foundation	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
The Cleveland Clinic	UCB Pharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary efficacy variable will be change in seizure frequency.
Secondary	Determine the design of a larger placebo controlled monotherapy study of the use of levetiracetam for CAE.