- Seizures classified as Primary Generalized Tonic Clonic Seizures
- Must have at least 1 PGTC seizure in the 8 weeks prior to screening
- Must have a minimum of 3 PGTC seizures during the 8-week baseline phase and at least 1
PGTC in each 4-week period of the baseline phase
- Currently receiving adequate and stable dosage of 1 to 3 anti-epileptic treatments
(stable within 28 days of screening)
- Signed informed consent and assent if a minor
- Ability to comply with daily seizure and dosing diary requirements and all study
procedures
- A current diagnosis of febrile seizures, or seizures related to an ongoing acute
medical illness
- Focal seizures (simple partial, complex partial, or partial becoming secondarily
generalized)
- Status Epilepticus within 1 year prior to screening
- Lennox-Gastaut syndrome, infantile spasms, Benign Epilepsy with Centrotemporal Spikes
(BECTS) and Dravet syndrome
- Seizures related to drugs, alcohol, or acute medical illness
- Any change in anti-epileptic treatment regimen (type of medication or dose; VNS
alteration) within 28 days of the screening visit or during the baseline phase
- Progressive or potentially progressive structural CNS lesion or a progressive
encephalopathy.
- Progressive inborn errors of metabolism.