Open-label Extension to Protocol 1042-0600
Condition: Epilepsies, Partial
MeSH terms: Epilepsy; Epilepsies, Partial
Intervention: ganaxolone
Intervention description: liquid suspension dosed tid
Intervention MeSH terms: Ganaxolone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 123.0
Sex: All
Minimum age: 18 Years
Maximum age: 69 Years
Healthy volunteers: No
Keywords: partial onset epilepsy; adult epilepsy; partial seizures; anticonvulsant; catamenial epilepsy; adult partial onset epilepsy

Summary:

      To allow open-label extension to patients who have completed Protocol 1042-0600.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Participants who have completed all scheduled clinical study visits in the previous
             protocol 1042-0600 and have been deemed eligible (no major adverse events thought to
             be drug related) by the Investigator.

          2. Diagnosis of epilepsy with CPS with or without secondarily generalized seizures
             according to the International League Against Epilepsy [ILAE] Classification of
             Epileptic Seizures (1981). Diagnosis should have been established by clinical history
             and computerized tomography (CT) or magnetic resonance imaging (MRI) of the brain to
             rule out progressive structural lesions and electroencephalogram (EEG) or video EEG
             with results consistent with partial-onset epilepsy.

          3. Male or female, 18 to 69 years of age (inclusive). [Note: Participants who are > 69
             years of age but are of good health condition may be allowed to enter the study after
             discussion with and approval by the Medical Monitor.]

          4. A 12-lead electrocardiogram (ECG) without clinically significant abnormalities.

          5. Be properly informed of the nature and risks of the study and give informed consent in
             writing, prior to entering the study.

          6. Able to participate for the full term of study.

          7. Able to keep a seizure diary throughout the course of the study.

          8. Sexually active women of childbearing potential must be using a medically acceptable
             method of birth control and have a negative qualitative serum beta-human chorionic
             growth hormone (beta HCG) pregnancy test result from a blood sample collected at the
             initial screening visit. A woman of childbearing potential is defined as a female who
             is biologically capable of becoming pregnant. A medically acceptable method of birth
             control includes intrauterine devices in place for at least 3 months, surgical
             sterilization, or adequate barrier methods (e.g., diaphragm and foam). An oral
             contraceptive alone is not considered adequate for the purpose of this study. Use of
             oral contraceptives in combination with another method (e.g., a spermicidal cream) is
             acceptable. In participants who are not sexually active, abstinence is an acceptable
             form of birth control and qualitative serum βHCG pregnancy tests must be tested per
             protocol.

          9. Participants with a history of depression must be stable and may be taking one
             antidepressant medication

        Exclusion Criteria:

          1. Presence of non-motor simple partial seizures only.

          2. History of pseudoseizures in the last 5 years.

          3. History of a primary generalized seizure in the last 5 years.

          4. Past use of vigabatrin without stable visual fields tested twice over the 12 months
             after the last dose of vigabatrin (Concomitant use of vigabatrin is not allowed).

          5. Seizures secondary to illicit drug or alcohol use, infection, neoplasm, demyelinating
             disease, degenerative neurological disease, or CNS disease deemed progressive,
             metabolic illness, or progressive degenerative disease.

          6. Status epilepticus within the last year prior to randomization in 1042-0600 study.

          7. Clinically unstable psychiatric disorder within the last 2 years.

          8. Suicide attempt within the last 5 years or current significant suicidal ideation.

          9. History of psychosis within the last 5 years.

         10. Current use of neuroleptics for psychosis.

         11. A significant medical or surgical condition at screening which might compromise the
             hematologic, cardiovascular, pulmonary, renal, gastrointestinal, or hepatic systems or
             other conditions that would place the participant at increased risk.

         12. Known sensitivity or allergy to progesterone or related steroid compounds.

         13. History of drug use or alcohol abuse within the past 5 years.

         14. Sexually active women of childbearing potential (WCBP) who are unwilling to use a
             double-barrier method and establish that they are currently not pregnant by submitting
             to a serum pregnancy test.

         15. A history of chronic noncompliance with drug regimens.

         16. Females who are currently breastfeeding.

         17. Exposure to any other investigational drug within 30 days prior to randomization in
             1042-0600 study.

         18. Aspartate transaminase (AST) or alanine transaminase (ALT) levels > 3 times the upper
             limit of normal (ULN) at screening.

         19. Participant has history of repetitive seizures within the 12-month period preceding
             study entry where the individual seizures cannot be counted.

         20. Inability to withhold grapefruit and grapefruit juice from diet during the entire
             clinical trial.