To allow open-label extension to patients who have completed Protocol 1042-0600.
This is an open-label study evaluating efficacy and safety of ganaxolone treatment in adults with partial onset epilepsy with or without secondary generalizations.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
123
liquid suspension dosed tid
Percent Change From Baseline in Weekly Seizure Frequency During Weeks 1 Through 117
Percent Change in weekly seizure frequency by treatment group compared to Baseline at the beginning of the double-blind study 1042-0600 is presented. Weekly seizure frequency included partial-onset seizures (POS) with or without secondary generalization, but not non-motor simple partial seizure (SPS) during Weeks 1 through Week 117. Baseline was defined as the Day 0 assessment before study drug infusion of the double-blind study 1042-0600.
Time frame: Baseline (Day 0) and Week 1 through Week 117
Number of Responders During Weeks 1 Through 117
Responders were defined as participants experiencing ≥50% of reduction in mean weekly seizure frequency from the Baseline. Baseline was defined as the Day 0 assessment before study drug infusion of the double-blind study 1042-0600.
Time frame: Baseline (Day 0) and Week 1 through Week 117
Number of Seizure-free Days During Weeks 1 Through 117
Average number of seizure-free days per week for a given period was calculated as follows: (Total number of days with no seizures of any type during that period / number of days with seizure diary in that period) multiplied by 7.
Time frame: Week 1 through Week 117
Number of Seizure-free Participants
Number of Seizure-free participants is presented.
Time frame: Day 1 through Day 224 (Week 32)
Change From Baseline in Quality of Life in Epilepsy Inventory-31 (QOLIE-31) Questionnaire
QOLIE-31 was a survey of health-related QOL for adults with epilepsy and evaluated how much distress the participant feels about problems and worries related to epilepsy. It included 38 items grouped into eight multi-item subscales - Energy/Fatigue, Emotional Well-Being, Daily Activities/Social Functioning, Cognitive Functioning, Medication Effect, Seizure Worry, Overall Quality of Life (QoL) and Distress. The subscale scores and the total score were calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100; higher scores indicated better function. Baseline was defined as the last non-missing observation prior to the first dose in double-blind study 1042-0600. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
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University of Alabama
Birmingham, Alabama, United States
Barrow Neurological Institute
Phoenix, Arizona, United States
Arkansas Epilepsy Program
Little Rock, Arkansas, United States
University of Southern California Adult Comprehensive Epilepsy Center
Los Angeles, California, United States
University of California-Davis
Sacramento, California, United States
Anchutz Outpatient Pavillion Neurosciences Clinic/ University of Colorado Hospital
Aurora, Colorado, United States
Yale University School of Medicine
New Haven, Connecticut, United States
University of Florida McKnight Brain Institute
Gainesville, Florida, United States
Intercoastal Neurology
Sarasota, Florida, United States
Emory HealthCare
Atlanta, Georgia, United States
...and 15 more locations
Time frame: Baseline (Day 0) and up to Week 104