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

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ClinicalTrials.gov Identifier: NCT01002820
Recruitment Status : Completed
First Posted : October 27, 2009
Last Update Posted : August 26, 2020
Sponsor:
Information provided by (Responsible Party):
Marinus Pharmaceuticals

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

Condition or disease Intervention/treatment Phase
Epilepsy, Complex Partial Drug: ganaxolone Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : October 2009
Actual Primary Completion Date : October 2010
Actual Study Completion Date : August 2013

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Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. safety as determined by adverse events [ Time Frame: one year ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01002820


Locations
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United States, California
University of Southern California, Dept of Neurology
Los Angeles, California, United States, 90033
United States, Kentucky
University of Kentucky, Dept of Neurology
Lexington, Kentucky, United States, 40536
United States, New York
Albany Medical Center, Dept of Neurology
Albany, New York, United States, 12208
United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43210
United States, Pennsylvania
Riddle Health Care Center II
Philadelphia, Pennsylvania, United States, 19063
Thomas Jefferson University, Comprehensive Epilepsy Center
Philadelphia, Pennsylvania, United States, 19107
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Marinus Pharmaceuticals
Investigators
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Study Director: Joseph Hulihan, MD Marinus Pharmaceuticals, Inc.
More Information
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Responsible Party: Marinus Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01002820    
Other Study ID Numbers: 1042-0602
First Posted: October 27, 2009    Key Record Dates
Last Update Posted: August 26, 2020
Last Verified: August 2020
Keywords provided by Marinus Pharmaceuticals:
Epileptic Seizures
Seizure Disorder
Seizures
Convulsions
 Anticonvulsant
Anticonvulsive
Antiepileptic
Ganaxolone
Additional relevant MeSH terms:
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Epilepsy, Complex Partial
Epilepsy
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Epilepsies, Partial