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

August 13, 2022 updated by: Marinus Pharmaceuticals

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90033
        • University of Southern California, Dept of Neurology
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky, Dept of Neurology
    • New York
      • Albany, New York, United States, 12208
        • Albany Medical Center, Dept of Neurology
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19063
        • Riddle Health Care Center II
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University, Comprehensive Epilepsy Center
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Investigators Global Assessment
Time Frame: 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.
Screening through 52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marinus Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

October 16, 2009

First Submitted That Met QC Criteria

October 23, 2009

First Posted (Estimate)

October 27, 2009

Study Record Updates

Last Update Posted (Actual)

September 7, 2022

Last Update Submitted That Met QC Criteria

August 13, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1042-0602

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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