Epilepsy, Tonic-Clonic
Conditions
Keywords
PGTC, Lamotrigine, epilepsy, seizures, primary generalized tonic-clonic
Brief summary
The purpose of this study is to evaluate the effectiveness and safety of an investigational new drug for supplemental therapy in subjects with primary generalized tonic-clonic (PGTC) seizures.
Interventions
DRUGlamotrigine
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
No
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
* 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 |
|---|---|
| % change from Baseline in average monthly PGTC seizure frequency | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects with >/= 25%, 50%, 75% or 100% reduction in PGTC seizures %change from Baseline in average monthly seizure frequency. | — |
Countries
Argentina, Chile, Peru, United States
Outcome results
None listed