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 (10.2mg/kg/day) 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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
54
Lamotrigine will be given as chewable dispersible tablets with dosing strengths of 2, 5, 25, and 100 milligrams.
GSK Investigational Site
San Jose, California, United States
GSK Investigational Site
Loxahatchee Groves, Florida, United States
GSK Investigational Site
Melbourne, Florida, United States
GSK Investigational Site
Panama City, Florida, United States
GSK Investigational Site
Tallahassee, Florida, United States
GSK Investigational Site
Tampa, Florida, United States
GSK Investigational Site
Atlanta, Georgia, United States
GSK Investigational Site
Louisville, Kentucky, United States
GSK Investigational Site
Springfield, Missouri, United States
GSK Investigational Site
Newark, New Jersey, United States
...and 13 more locations
The proportion of subjects with no typical absence seizures for two consecutive weeks as confirmed by hyperventilation (HV) for clinical signs and 1-hour electroencephalogram (EEG)
Time frame: Up to 8 months
Freq of seizures pre/post-treatment with lamotrigine, proportion of subjects with >=25, 50 and 75% decrease in seizure frequency, proportion of subjects with >=25, 50 and 75% decrease in clinical signs.
Time frame: Up to 8 months
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