A double-blind, placebo-controlled study to evaluate the safety, tolerability and potential antiseizure activity of adjunctive OV-329 in adult focal epilepsy patients.

Exclusion Criteria23

• Previous exposure to OV329
• Exposure to any investigational drug or device less than or equal to 30 days prior to screening or plans to take another investigational drug at any time during the study.
• Any past or current history of an ophthalmologic condition that is congenital, infectious, genetic or acquired, that required medication, surgery or ongoing care (see protocol for further details)
• Time of onset of epilepsy treatment < 2 years prior to enrollment
• Have generalized or combined focal and generalized epilepsy, or non-epileptic seizures within the last 12- month period prior to study entry.
• Have fewer than 4 countable focal onset seizures in a 28-day period and/ or have greater than or equal to 21 consecutive seizure-free days during the prospective baseline period.
• Have only focal aware seizures without any observable motor component.
• Have uncountable seizures or status epilepticus within the last 12 months prior to screening.
• Have more than 100 total countable per 4-wk baseline period.
• Current use of vigabatrin is not permitted
• Seizures secondary to illicit drug or alcohol use, infection, neoplasm, demyelinating disease, degenerative neurological disease, or central nervous system (CNS) disease deemed progressive, metabolic illness or progressive degenerative disease.
• History of or any current evidence of spinal stenosis, neuroinflammatory disorders, chronic inflammatory demyelinating polyneuropathy (CIDP), or malignancy within the last five years.
• Uncontrolled diabetes, alcohol abuse, history of B12 or folate deficiency
• Pre-existing peripheral neuropathy
• History of stroke or other uncontrolled serious medical illness, myocardial infarction within 6 months of baseline, congestive heart failure, history of long QT syndrome, a long QTcB or clinically significant laboratory abnormalities.
• History or presence of gastritis, gastrointestinal tract, gastric bypass surgery, or hepatic disorder or other clinical condition which, in the opinion of the Investigator or designee, may affect the absorption, distribution, metabolism, or elimination of study drug. And, recent history of abnormal bowel movements, such as diarrhea, loose stools, or constipation, within 2 weeks prior to first dosing.
• History or presence of drug abuse within the past 2 years prior to Screening visit.
• History or presence of hypersensitivity or idiosyncratic reaction to the study drug or related compounds.
• Use of concomitant medications that are OAT inhibitors
• A history of chronic noncompliance with drug regimens.
• Plans to have any surgery during the screening and treatment or follow up periods.
• Risk of suicide according to the Investigator’s clinical judgment or has made a suicide attempt in the previous year prior to Screening visit.
• Pregnant or lactating