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

Phase 2

Completed

• Conditions: Epilepsy, Complex Partial
• Interventions: Drug: ganaxolone

• Registration Number: NCT01002820
• Lead Sponsor: Marinus Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-10-16
• Study First Submitted QC: 2009-10-23
• Study First Posted: 2009-10-27
• Primary Completion: 2010-10
• Disposition First Submitted: 2012-04-18
• Disposition First Submitted QC: 2012-04-18
• Disposition First Posted: 2012-04-20
• Study Completion: 2013-08
• Status Verified: 2022-05
• Results First Submitted: 2022-05-26
• Results First Submitted QC: 2022-08-13
• Last Update Submitted: 2022-08-13
• Results First Posted: 2022-09-07
• Last Update Posted: 2022-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
participants	ganaxolone	all subjects participating in 0602 are receiving ganaxolone for seizure control

Primary Outcome Measures

Name	Time	Method
Investigators Global Assessment	Screening through 52 weeks	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.

Trial Locations

Locations (7)

Ohio State University; 🇺🇸 Columbus, Ohio, United States

Riddle Health Care Center II; 🇺🇸 Philadelphia, Pennsylvania, United States

Thomas Jefferson University, Comprehensive Epilepsy Center; 🇺🇸 Philadelphia, Pennsylvania, United States

University of Southern California, Dept of Neurology; 🇺🇸 Los Angeles, California, United States

Albany Medical Center, Dept of Neurology; 🇺🇸 Albany, New York, United States

University of Kentucky, Dept of Neurology; 🇺🇸 Lexington, Kentucky, United States

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States