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

Primary Purpose

Epilepsy, Complex Partial

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ganaxolone
Sponsored by
Marinus Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy, Complex Partial focused on measuring Epileptic Seizures, Seizure Disorder, Seizures, Convulsions, Anticonvulsant, Anticonvulsive, Antiepileptic, Ganaxolone

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Southern California, Dept of Neurology
  • University of Kentucky, Dept of Neurology
  • Albany Medical Center, Dept of Neurology
  • Ohio State University
  • Riddle Health Care Center II
  • Thomas Jefferson University, Comprehensive Epilepsy Center
  • Virginia Commonwealth University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

participants

Arm Description

all subjects participating in 0602 are receiving ganaxolone for seizure control

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
October 16, 2009
Last Updated
August 13, 2022
Sponsor
Marinus Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01002820
Brief Title
A Treatment Use Protocol for Subjects Continuing on From the Open-label Extension 0601
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Marinus Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy, Complex Partial
Keywords
Epileptic Seizures, Seizure Disorder, Seizures, Convulsions, Anticonvulsant, Anticonvulsive, Antiepileptic, Ganaxolone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
participants
Arm Type
Experimental
Arm Description
all subjects participating in 0602 are receiving ganaxolone for seizure control
Intervention Type
Drug
Intervention Name(s)
ganaxolone
Other Intervention Name(s)
CCD 1042, CAS 383-98323-2, 3 alpha-hydroxy, 3 beta-methyl, 5 alpha-pregnan-20-one
Intervention Description
liquid suspension, 50 mg/mL, up to 500 mg/day TID or 1500 mg/day, up to 1 year
Primary Outcome Measure Information:
Title
Investigators Global Assessment
Description
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.
Time Frame
Screening through 52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of Southern California, Dept of Neurology
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
University of Kentucky, Dept of Neurology
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Albany Medical Center, Dept of Neurology
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Riddle Health Care Center II
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19063
Country
United States
Facility Name
Thomas Jefferson University, Comprehensive Epilepsy Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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