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| Sponsors and Collaborators: |
The Cleveland Clinic UCB |
|---|---|
| Information provided by: | The Cleveland Clinic |
| ClinicalTrials.gov Identifier: | NCT00361010 |
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: | Treatment, Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | A Pilot Study of Efficacy and Tolerability of Levetiracetam Monotherapy in Subjects With Childhood Absence Epilepsy |
| Estimated Enrollment: | 20 |
| Estimated Study Completion Date: | September 2008 |
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Ohio | |
| The Cleveland Clinic Foundation | |
| Cleveland, Ohio, United States, 44195 | |
| The Cleveland Clinic | |
| Cleveland, Ohio, United States, 44195 | |
| Principal Investigator: | Deepak K Lachhwani, MD | The Cleveland Clinic, Division of Pediatric Neurology |
More Information
| Study ID Numbers: | KeppraCAE |
| Study First Received: | August 3, 2006 |
| Last Updated: | June 9, 2008 |
| ClinicalTrials.gov Identifier: | NCT00361010 |
| Health Authority: | United States: Institutional Review Board |
|
Keppra Epilepsy Childhood Absence Epilepsy Seizures |
|
Signs and Symptoms Epilepsy Epilepsy, Absence Seizures Neurologic Manifestations |
Central Nervous System Diseases Etiracetam Epilepsy juvenile absence Epilepsy, Generalized Brain Diseases |
|
Nootropic Agents Therapeutic Uses Nervous System Diseases |
Central Nervous System Agents Pharmacologic Actions Anticonvulsants |
