['epilepsy']
['ganaxolone']

        Key Inclusion Criteria:

          1. Have parent or legal guardian available and willing to give written informed consent.

          2. Male and female outpatients between 2 and 18 years of age years of age at time of
             consent.

          3. Have any of the following epilepsy syndromes: PCDH19; CDKL5; Dravet Syndrome; Lennox
             Gastaut Syndrome (LGS); Continuous Spikes and Waves during Sleep (CSWS)

          4. Have uncontrolled cluster seizures and/or non-clustered seizures.

          5. Subjects should be on a stable regimen of anti-epileptic medication, and generally in
             good health.

          6. Parent or guardian is able and willing to maintain an accurate and complete daily
             written seizure calendar.

          7. Able and willing to take study medication with food, two or three times daily.

        Key Exclusion Criteria

          1. Have had previous exposure to ganaxolone.

          2. Known sensitivity or allergy to any component in the study drug, progesterone, or
             other related steroid compounds.

          3. Exposure to any investigational drug or device < 90 days prior to screening, or plans
             to participate in another drug or device trial at any time during the study.

          4. Concurrent use of vigabatrin, tiagabine, or ezogabine is not permitted.

          5. 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,
             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.

          6. Have active suicidal plan/intent, or have had active suicidal thoughts in the past 6
             months or a suicide attempt in the past 3 years.

          7. 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 at the screening
             and baseline visits.
      