Phase 3 Study of Adjunctive Ganaxolone in Adults With Drug-resistant Partial Onset Seizures and Open-label Extension

Exclusion Criteria

• •Have had previous exposure to ganaxolone
• •Known sensitivity or allergy to any component in the study drug, progesterone, or other related steroid compounds
• •Exposure to any investigational drug or device \<30 days prior to screening, or plans to take another investigational drug at any time during the study
• •Time of onset of epilepsy treatment \<2 years prior to enrollment
• •Have generalized epilepsy, such as Lennox-Gastaut syndrome, juvenile myoclonic epilepsy, absence epilepsy, or non-epileptic seizures within the last 12- month period prior to study entry
• •Have less than 3 POS seizures in a 28-day period or more than 21 consecutive seizure-free days during the Baseline period
• •Have only simple partial seizures without any observable motor component
• •Have innumerable seizures or status epilepticus within the last 12-months prior to screening
• •Have more than 100 POS per 4-week Baseline period
• •Have 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
• •Current use of vigabatrin is not permitted. If prior use of vigabatrin, must have documented stable visual fields
• •Current use of ezogabine is not permitted. If prior use, must have been off the medication for at least 3 months prior to screening and have had documented normal fundoscopic exam by ophthalmologist
• •Are planning surgery, or to be evaluated for surgery, during the double-blind phase to control seizures including VNS implantation
• •Are suffering from acute or progressive neurological disease, moderate or severe psychiatric disease, or severe mental abnormalities that are likely to require changes in drug therapy during the double-blind portion of the study or interfere with the objectives of the study or the ability to adhere to the protocol requirements
• •Have a history of an actual suicide attempt in the last 5 years or more than 1 lifetime suicide attempt
• •Have a positive urine drug screen at Screening or meet criteria for current or historical Substance Use Disorder (DSM-V criteria) within the past 5 years.
• •Have any medical condition that, in the investigator's judgment, is considered to be clinically significant and could potentially affect participant safety or study outcome, including but not limited to: clinically significant cardiac, renal, pulmonary, gastrointestinal, hematologic or hepatic conditions; or a condition that affects the absorption, distribution, metabolism or excretion of drugs
• •Have elevated ALT (SGPT) or AST (SGOT) greater than 3 times upper limits of normal, or total bilirubin greater than 1.5 times ULN
• •Have a history of malignancy within the past 2 years, with the exception of basal cell carcinoma
• •Are currently following or planning to follow a ketogenic diet
• •Use of dietary supplements or herbal preparations are not permitted if participant has been using them consistently for less than 6 months prior to screening, or does not plan on remaining on stable doses for the duration of the double blind phase. Use of St. John's Wort is not permitted
• •Females who are pregnant, currently breastfeeding or planning to become pregnant during the duration of the study
• •A history of chronic noncompliance with drug regimens
• •Inability to withhold grapefruit and grapefruit juice from diet during the entire clinical trial