A Treatment Use Protocol for Subjects Continuing on From the Open-label Extension 0601 (0602)

Marinus Pharmaceuticals

Status and phase

Completed

Phase 2

Conditions

Epilepsy, Complex Partial

Treatments

Drug: ganaxolone

Study type

Interventional

Funder types

Industry

Identifiers

1042-0602

Details and patient eligibility

About

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

Enrollment

11 patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

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