A Treatment Use Protocol for Subjects Continuing on From the Open-label Extension 0601

Study Overview
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Brief Summary
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This study is designed to provide ganaxolone to those patients deriving significant benefit from current treatment in protocol 1042-0601.

Official Title
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A Treatment Protocol for Ganaxolone as add-on Therapy in Adult Patients With Uncontrolled Partial-onset Seizures Deriving Benefit From Protocol 1042-0601

Conditions
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Epilepsy, Complex Partial

Intervention / Treatment
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* Drug: ganaxolone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: subjects who have completed all study visits from previous protocol 1042-0601 and have been deemed eligible by the Investigator as: having had no major adverse events thought to be drug related deriving benefit from ganaxolone treatment be properly informed of the nature and risks of the study and give written informed consent prior to study entry must be willing to use a medically acceptable method of birth control and if female of child-bearing potential, have a negative qualitative serum pregnancy test Exclusion Criteria: significant medical or surgical condition at screening or that develops during protocol participation that might compromise hematologic, cardiovascular, pulmonary, renal, gastrointestinal, or hepatic systems, or other conditions that would place the subject under increased risk unwilling to use a double-barrier method of birth control or submit to a serum pregnancy test history of chronic non-compliance with drug regimens females currently breastfeeding AST or ALT levels greater than 3 times the upper limit of normal at screen Inability to withhold grapefruit or grapefruit products during the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: participants<br>all subjects participating in 0602 are receiving ganaxolone for seizure control | Drug: ganaxolone<br>* liquid suspension, 50 mg/mL, up to 500 mg/day TID or 1500 mg/day, up to 1 year<br>* Other names: 3 alpha-hydroxy, 3 beta-methyl, 5 alpha-pregnan-20-one;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigators Global Assessment | Investigator's global assessment of the patient's response to ganaxolone treatment was collected during the study to support continued trial participation. The investigator's global assessment of the patient's response to ganaxolone treatment was collected during the study to support continued trial participation. Responses categories were Improved Markedly, Improved Moderately, Improved Slightly and No change from baseline. | Screening through 52 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Epileptic Seizures, Seizure Disorder, Seizures, Convulsions, Anticonvulsant, Anticonvulsive, Antiepileptic, Ganaxolone