Safety & Efficacy of Eslicarbazepine Monotherapy in Sub.w/Partial Epilepsy Not Well Controlled by Current Antiepileptic

This is an 18-week, double-blind, randomized, historical control, multicenter study with
gradual conversion to monotherapy in subjects with partial onset seizures who are not well
controlled by current AEDs. The 18 week double-blind treatment period consists of a 2-week
titration period, 6-week taper or conversion period, and a 10-week monotherapy period. This
study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by
Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion
Pharmaceuticals Inc.

Inclusion Criteria:

- Diagnosis of partial epilepsy as defined in the Classification of Seizures of the
International League Against Epilepsy (ILAE) (simple partial seizures with observable
motor component, or complex, with or without secondary generalization)

- Medical history of seizures;

- Absence of confounding factors (pseudoseizures, syncope);

- Documented EEG recording (done within 5 years prior to screening) consistent
with focal onset epilepsy

- Documented CT or MRI scan conducted within 10 years prior to screening, showing the
absence of a structural abnormality (eg, tumor or malformation)

- ≥ 4 partial onset seizures during the 8 weeks prior screening with no 28-day seizure
free period

- Stable treatment with 1-2 AEDs during the last 4 weeks prior to screening

- Subjects must have the ability to comprehend the informed consent form and be willing
to provide informed consent. For subjects who are unable to comprehend the written
consent, a witness/caregiver who is able to describe and provide an understanding of
the informed consent to the subject must sign the consent form on behalf of the
subject.

- Subjects must give written informed consent prior to participation in the study. For
subjects <18 years of age, the informed consent must be signed by the subject's
parent or legal guardian, and, when appropriate and/or required by state or local
law, minor subjects must give written informed assent prior to participation in the
study. Subjects of Asian ancestry are required to give written informed consent for
genotyping. All subjects must sign a HIPAA Form. All females of child bearing
potential must also sign the "Women of Childbearing Potential" Addendum.

- A female subject is eligible to enter and participate in the study if she is of:

- Non-childbearing potential (ie, physiologically incapable of becoming pregnant,
including any female who is pre-menarchal or post-menopausal);

- Child-bearing potential (all females ≤65 years of age), has a negative pregnancy
test at screening and agrees to satisfy contraception requirements

Exclusion Criteria:

- Subjects with only simple partial seizures without a motor component

- Presence of generalized seizure syndromes (eg, juvenile myoclonic epilepsy or
Lennox-Gastaut syndrome)

- History of pseudo-seizures

- Current seizures related to an acute medical illness

- Seizures secondary to metabolic, toxic or infectious disorder or drug abuse

- Status epilepticus within 2 years prior to screening

- Seizures only occurring in a cluster pattern

- Subjects taking 2 of the following sodium channel blocking AEDs: phenytoin,
carbamazepine, oxcarbazepine, or lamotrigine

- Subjects taking 2 AEDs with both being in the upper dose range (defined as
approximately two-thirds of the defined daily dose)

- Subjects taking more than 2 AEDs

- Subjects with progressive structural central nervous system lesion or progressive
encephalopathy

- Psychiatric exclusion criteria

- Medical exclusion criteria: known renal insufficiency (estimated creatinine clearance
[CrCL]) <60 mL/min based on serum creatinine using the Cockcroft-Gault formula

- Clinical and laboratory exclusion criteria: Subjects of Asian ancestry who tests
positive for the presence of the HLA-B*1502 allele

- Subjects who have been on benzodiazepines, phenobarbital, or primidone on a regular
basis within 3 months prior to screening

- Subjects taking antipsychotics, tricyclic antidepressants, anxiolytics, sedative
hypnotics including non-benzodiazepines, central opioid agonists/antagonists,
monoamine oxidase inhibitors (MAOIs) within at least 5 half lives (or for at least 2
weeks whichever is longer) prior to randomization

- Subjects presently on felbamate or vigabatrin