Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Marinus Pharmaceuticals
Age
18–55
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | A Treatment Use Protocol for Subjects Continuing on From the Open-label Extension 0601
