LAMICTAL (Lamotrigine) For The Treatment Of Absence Seizures
Status:
Completed
Trial end date:
2006-04-22
Target enrollment:
Participant gender:
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 (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.