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

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

NCT01002820•Marinus Pharmaceuticals

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Summary

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

Eligibility

Age

18 - 55 years

Sex

ALL

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

Locations (7)

University of Southern California, Dept of Neurology

Los Angeles, California, United States

University of Kentucky, Dept of Neurology

Lexington, Kentucky, United States

Albany Medical Center, Dept of Neurology

Albany, New York, United States

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

Virginia Commonwealth University

Richmond, Virginia, United States

Key Dates

Start Date

October 1, 2009

Primary Completion Date

October 1, 2010

Completion Date

August 1, 2013

Last Updated

September 7, 2022

Enrollment

ACTUAL participants

Conditions

Epilepsy, Complex Partial

Interventions

ganaxolone

DRUG

Pregabalin Open-Label Extension Trial in Patients With Partial Seizures

NCT00143143

Epilepsies, PartialEpilepsy, Complex Partial

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 7, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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