Epilepsy, Complex Partial Clinical Trial
— 0602Official title:
A Treatment Protocol for Ganaxolone as add-on Therapy in Adult Patients With Uncontrolled Partial-onset Seizures Deriving Benefit From Protocol 1042-0601
NCT number | NCT01002820 |
Other study ID # | 1042-0602 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | October 2009 |
Est. completion date | August 2013 |
Verified date | May 2022 |
Source | Marinus Pharmaceuticals |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study is designed to provide ganaxolone to those patients deriving significant benefit from current treatment in protocol 1042-0601.
Status | Completed |
Enrollment | 11 |
Est. completion date | August 2013 |
Est. primary completion date | October 2010 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Albany Medical Center, Dept of Neurology | Albany | New York |
United States | Ohio State University | Columbus | Ohio |
United States | University of Kentucky, Dept of Neurology | Lexington | Kentucky |
United States | University of Southern California, Dept of Neurology | Los Angeles | California |
United States | Riddle Health Care Center II | Philadelphia | Pennsylvania |
United States | Thomas Jefferson University, Comprehensive Epilepsy Center | Philadelphia | Pennsylvania |
United States | Virginia Commonwealth University | Richmond | Virginia |
Lead Sponsor | Collaborator |
---|---|
Marinus Pharmaceuticals |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Screening through 52 weeks |
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