None listed
Conditions
Interventions
Lamotrigine Type of group
Subjects who complete the Maintenance Phase or who withdraw prematurely from study treatment due to exacerbation of their crises or intolerable side effects, will have the option of moving to the group receiving lamotrigine in the open phase of the study, for 1 year (52 weeks), when clinically appropriate, for the purpose of long-term follow-up. The transition to lamotrigine therapy will be carried out in a double blind modality. For the subjects treated with lamotrigine, the total daily dose sh
The placebo will be administered until clinically appropriate, then lamotrigine will be administered.
Sponsors
GLAXOSMITHKLINE RESEARCH TRIANGLE PARK,
Eligibility
Inclusion criteria
Inclusion criteria: Weigh at least 13kg. Have a confident diagnosis of epilepsy with primary generalized tonic-clonic (PGTC) seizures with or without other generalized seizure types. Currently being treated with an antiepileptic drug(s) (AED). Benzodiazepines are allowed with some frequency restrictions. Vagus nerve stimulation is allowed if in place for at least 6 months prior to starting the study with no changes to the settings having occured during the month immediately prior to starting the study, and if no changes will occur during all phases of the study. History of primary generalized tonic-clonic seizures with no focal onset. Have at least 1 primary generalized tonic-clonic (PGTC) seizure during the 8 consecutive weeks prior to the baseline period of the study. Have at least 3 PGTC seizures occur anytime during the 8-week baseline phase of the study. Females must agree to acceptable form of birth control.
Exclusion criteria
Exclusion criteria: A history of partial seizures or interictal expression of partial seizures as evidenced by electroencephalogram. Have Lennox-Gastaut syndrome. Currently using or has previously used the drug being studied. Is abusing alcohol and/or other substance(s). Has taken an investigational drug during the 30 days prior to the study or plans to take an investigational drug anytime during the study. Is receiving chronic (long-term) treatment with any medication that could influence seizure control. Follows the ketogenic diet. Is planning surgery to control seizures during the study. Is suffering from acute or progressive neurological disease, severe psychiatric disease, or severe mental abnormality. Has any clinically significant heart, kidney, or liver condition, or a condition that affects how drugs are absorbed, distributed, metabolized, or removed from the body.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:PGTC seizures Measure:% change from Baseline in average monthly PGTC seizure frequency Timepoints:monthly | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:PGTC seizures Measure:Proportion of subjects with > = 25%, 50%, 75% or 100% reduction in PGTC seizures %change from Baseline in average monthly seizure frequency. Timepoints:monthly | — |
Countries
Argentina, Chile, Peru, United States
Outcome results
None listed