Ignite Creation Date:
2024-05-05 @ 5:01 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00361010
Status:
COMPLETED
Last Update Posted:
2011-07-28
First Post:
2006-08-03
Brief Title:
A Pilot Study of Efficacy and Tolerability of Levetiracetam Monotherapy in Subjects With Childhood Absence Epilepsy
Sponsor:
The Cleveland Clinic
Organization:
The Cleveland Clinic
Study Overview
Official Title:
A Pilot Study of Efficacy and Tolerability of Levetiracetam Monotherapy in Subjects With Childhood Absence Epilepsy
Status:
COMPLETED
Status Verified Date:
2011-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 US 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 parentalcaregiver 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None