Status:
COMPLETED
A Treatment Use Protocol for Subjects Continuing on From the Open-label Extension 0601
Lead Sponsor:
Marinus Pharmaceuticals
Conditions:
Epilepsy, Complex Partial
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
Brief Summary
This study is designed to provide ganaxolone to those patients deriving significant benefit from current treatment in protocol 1042-0601.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT01002820
Start Date
October 1 2009
End Date
August 1 2013
Last Update
September 7 2022
Active Locations (7)
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1
University of Southern California, Dept of Neurology
Los Angeles, California, United States, 90033
2
University of Kentucky, Dept of Neurology
Lexington, Kentucky, United States, 40536
3
Albany Medical Center, Dept of Neurology
Albany, New York, United States, 12208
4
Ohio State University
Columbus, Ohio, United States, 43210