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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00361010
Other study ID # KeppraCAE
Secondary ID
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


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.
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