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

Sponsor

Marinus Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT01002820

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

1.6

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Epilepsy, Complex Partial	Drug: ganaxolone	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

11 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 2009

Actual Primary Completion Date :

Oct 1, 2010

Actual Study Completion Date :

Aug 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: participants all subjects participating in 0602 are receiving ganaxolone for seizure control	Drug: ganaxolone liquid suspension, 50 mg/mL, up to 500 mg/day TID or 1500 mg/day, up to 1 year Other Names: CCD 1042 CAS 383-98323-2 3 alpha-hydroxy, 3 beta-methyl, 5 alpha-pregnan-20-one

Arm

Intervention/Treatment

Experimental: participants

all subjects participating in 0602 are receiving ganaxolone for seizure control

Drug: ganaxolone

liquid suspension, 50 mg/mL, up to 500 mg/day TID or 1500 mg/day, up to 1 year

Other Names:

CCD 1042

CAS 383-98323-2

3 alpha-hydroxy, 3 beta-methyl, 5 alpha-pregnan-20-one

Outcome Measures

Primary Outcome Measures

safety as determined by adverse events [one year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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
5	Riddle Health Care Center II	Philadelphia	Pennsylvania	United States	19063
6	Thomas Jefferson University, Comprehensive Epilepsy Center	Philadelphia	Pennsylvania	United States	19107
7	Virginia Commonwealth University	Richmond	Virginia	United States	23298