- Subjects and/or parent(s)/legally acceptable representative must be considered willing
and able to sign consent, and complete daily seizure diaries and monitor seizure
frequency.
- Male and female epilepsy subjects, 4 to 16 years of age inclusive on the date of the
Screening Visit.
- Diagnosis of epilepsy with partial onset seizures classified as simple partial,
complex partial or partial becoming secondarily generalized, according to the
International League Against Epilepsy (ILAE) Diagnosis criteria.
- Must have a partial onset seizure frequency of at least 3 seizures per 28 day period
prior to screening. Must have a partial onset seizure frequency of at least 6 seizures
and no continuous 4 week seizure free period during the 8 week baseline phase prior to
randomization.
- Currently receiving a stable dose of 1 to 3 antiepileptic drugs (stable within 28 days
prior to screening).
- Primary generalized seizures (including in the setting of co-existing partial onset
seizures) which include, for example: Clonic, tonic and clonic-tonic seizures (note
that partial onset seizures that become secondarily generalized are not exclusionary);
Absence seizures; Infantile spasms; Myoclonic, myoclonic atonic, myoclonic tonic
seizures.
- Lennox Gastaut syndrome, Benign Epilepsy with Centrotemporal Spikes (BECTS) and Dravet
syndrome.
- A current diagnosis of febrile seizures, or seizures related to an ongoing acute
medical illness. Any febrile seizures within 1 year of screening.
- Status epilepticus within 1 year prior to screening.
- Seizures related to drugs, alcohol, or acute medical illness.
- Any change in AED regimen (type of medication or dose) within 28 days of the Screening
Visit or during the Baseline Phase.
- Progressive structural CNS lesion or a progressive encephalopathy.