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

Arm | Intervention/treatment |
---|---|
Experimental: participants
all subjects participating in 0602 are receiving ganaxolone for seizure control
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Drug: ganaxolone
liquid suspension, 50 mg/mL, up to 500 mg/day TID or 1500 mg/day, up to 1 year
Other Names:
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- safety as determined by adverse events [ Time Frame: one year ]

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Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
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 |
Study Director: | Joseph Hulihan, MD | Marinus Pharmaceuticals, Inc. |
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 |
Epileptic Seizures Seizure Disorder Seizures Convulsions |
Anticonvulsant Anticonvulsive Antiepileptic Ganaxolone |
Epilepsy, Complex Partial Epilepsy Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Epilepsies, Partial |