Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00144872
Status:
COMPLETED
Last Update Posted:
2017-09-29
First Post:
2005-09-01
Brief Title:
LAMICTAL Lamotrigine For The Treatment Of Absence Seizures
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Evaluation of Lamotrigine in Subjects With Absence Seizures
Status:
COMPLETED
Status Verified Date:
2017-09
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:
This is an open-label study evaluating the efficacy and safety of lamotrigine LTG for the treatment of newly-diagnosed typical absence seizures Subjects will be children and adolescents 13 years of age It will be conducted at multiple sites in the US The study will consist of 4 phases Screen Phase up to 1 week Baseline Phase 24 hours Escalation Phase up to 20 weeks and Maintenance Phase 12 weeks Subjects will receive increasing doses of LTG according to the dosing schedule until attaining seizure freedom as confirmed by hyperventilation HV for clinical signs and a 1-hr EEG at 2 consecutive weekly visits At that point subjects will move into the 12-week Maintenance Phase Subjects who do not achieve seizure freedom upon reaching the maximum dose 102mgkgday with the specified dose escalation will be discontinued from the study During the Maintenance Phase the investigators will use their best effort to maintain the subjects at the efficacious dose reached If the subjects have unacceptable side effects or inadequate seizure control the doses of study drug can be increased or decreased as specified in the dosing schedule Safety will be assessed by monitoring adverse events laboratory assessments and serum lamotrigine levels Health outcomes assessments will also be conducted
Detailed Description:
None
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