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

Epilepsy, Complex Partial Clinical Trial

— 0602  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01002820
• Other study ID #: 1042-0602
• Status: Completed
• Phase: Phase 2
• Start date: October 2009
• Est. completion date: August 2013

Study information

• Verified date: May 2022
• Source: Marinus Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: August 2013
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Epilepsy, Complex Partial

Intervention

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

Locations

Country	Name	City	State
United States	Albany Medical Center, Dept of Neurology	Albany	New York
United States	Ohio State University	Columbus	Ohio
United States	University of Kentucky, Dept of Neurology	Lexington	Kentucky
United States	University of Southern California, Dept of Neurology	Los Angeles	California
United States	Riddle Health Care Center II	Philadelphia	Pennsylvania
United States	Thomas Jefferson University, Comprehensive Epilepsy Center	Philadelphia	Pennsylvania
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Marinus Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Investigators Global Assessment	Investigator's global assessment of the patient's response to ganaxolone treatment was collected during the study to support continued trial participation. The investigator's global assessment of the patient's response to ganaxolone treatment was collected during the study to support continued trial participation. Responses categories were Improved Markedly, Improved Moderately, Improved Slightly and No change from baseline.	Screening through 52 weeks