A Two-year Open-label Extension Study of Ganaxolone in Patients With Drug-resistant Partial-onset Seizures

This study is a 2-year, open-label continuation for those patients benefiting from ganaxolone
treatment after completing Protocol 1042-0603.

Inclusion Criteria:

- Subjects who have completed all scheduled clinical study visits in the previous
protocol 1042-0603 and have shown a minimum 35% improvement in mean 28-day seizure
frequency over the last three 28-day periods in study 1042-603 as compared to the
baseline of study 1042-603.

- Subjects whose daily study drug compliance in Study 1042-0603 was 90% or greater, and
for whom the investigator feels that the subject was compliant with the full dose as
prescribed.

- Able to give informed consent in writing, or have a legally authorized representative
able to do so, after being properly informed of the nature and risks of the study and
prior to engaging in any study-related procedures.

- Currently being treated and maintained with a stable regimen of 1, 2, or 3
anti-epileptic drugs (AED) at a consistent dose for one month prior to study entry.

- Implanted Vagus Nerve Stimulator (VNS) is permitted and will not count towards the
number of concomitant AEDs.

- Able and willing to maintain an accurate and complete daily written seizure calendar
or has a caregiver who is able and willing to maintain an accurate and complete daily
written seizure calendar.

- Able and willing to take drug with food twice daily. Ganaxolone must be administered
with food.

- Sexually active women of childbearing potential (WCBP) must be using a medically
acceptable method of birth control and have a negative pregnancy test at Visit 1 and
at subsequent visits.

Exclusion Criteria:

- Have any medical condition that, in the investigator's judgment, is considered to be
clinically significant and could potentially affect subject safety or study outcome

- Experienced a Serious Adverse Event or a moderate or severe medically important
adverse event judged probably or definitely related to open-label ganaxolone in the
previous study, 1042-0603

- Have Alanine transferase (ALT; SGPT) or Aspartate transferase (AST; SGOT) levels > 3
times upper limits of normal (ULN), or total bilirubin >1.5 time ULN during Study
1042-0603.

- Have a history of malignancy within the past 2 years, with the exception of basal cell
carcinoma.

- 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.

- Have active suicidal plan/intent, or have had active suicidal thoughts in the past 6
months. Have a history of an actual suicide attempt in the last 5 years or more than 1
lifetime actual suicide attempt as classified by the Columbia-Suicide Severity Rating
Scale (C-SSRS).

- Have a history of drug or alcohol abuse within the past 5 years. As with other AEDs,
the use of alcohol is not advised.

- Are currently following or planning to follow a ketogenic diet.

- Current use of vigabatrin or ezogabine (retigabine; Potiga; Trobalt) is not permitted.

- Females who are pregnant, currently breastfeeding or planning to become pregnant
during the study.

- Inability/unwillingness to withhold grapefruit and grapefruit juice from diet during
the entire clinical trial.