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

NCT00361010 | Completed

• 1 other identifier: KeppraCAE
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Epilepsy; Childhood Absence Epilepsy; Seizures

Keywords

Keppra; Epilepsy; Childhood Absence Epilepsy; Seizures

Outcome Measures

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.

Interventions

Levetiracetam DRUG

Eligibility Criteria

• Age: 4 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead
• UCB Pharma: collaborator

Study Sites (2)

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

The Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Epilepsy; Epilepsy, Absence; Seizures

Interventions

Levetiracetam

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Deepak K Lachhwani, MD

  The Cleveland Clinic, Division of Pediatric Neurology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 3, 2006
• First Posted: August 7, 2006
• Study Start: December 1, 2006
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: July 28, 2011

Record last verified: 2011-07

Locations

US (2)