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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE October 16, 2009
First Posted Date  ICMJE October 27, 2009
Last Update Posted Date August 26, 2020
Study Start Date  ICMJE October 2009
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 23, 2009)
safety as determined by adverse events [ Time Frame: one year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Treatment Use Protocol for Subjects Continuing on From the Open-label Extension 0601
Official Title  ICMJE A Treatment Protocol for Ganaxolone as add-on Therapy in Adult Patients With Uncontrolled Partial-onset Seizures Deriving Benefit From Protocol 1042-0601
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Epilepsy, Complex Partial
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: participants
all subjects participating in 0602 are receiving ganaxolone for seizure control
Intervention: Drug: ganaxolone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 23, 2009)
11
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2013
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01002820
Other Study ID Numbers  ICMJE 1042-0602
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Marinus Pharmaceuticals
Study Sponsor  ICMJE Marinus Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Joseph Hulihan, MD Marinus Pharmaceuticals, Inc.
PRS Account Marinus Pharmaceuticals
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP