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

• Status: Completed
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Marinus Pharmaceuticals
• Treatments: Ganaxolone; Pregnanolone

Criteria

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