A Randomized, Controlled Trial of Ganaxolone in Adult Uncontrolled Partial-Onset Seizures
- Conditions
- Partial EpilepsyCatamenial Epilepsy
- Interventions
- Other: Placebo
- Registration Number
- NCT00465517
- Lead Sponsor
- Marinus Pharmaceuticals
- Brief Summary
The study will evaluate the effectiveness and safety of an investigational drug-ganaxolone - on partial seizure frequency in adults with epilepsy taking a maximum of 3 antiepileptic medications (AEDs). The study will also evaluate the effectiveness of ganaxolone in females with catamenial epilepsy.
Catamenial epilepsy refers to a relationship between seizure frequency and a woman's menstrual cycle, where the number of seizures increases around the time of a woman's menstrual cycle.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 147
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description non-active drug Placebo placebo ganaxolone Ganaxolone active study drug
- Primary Outcome Measures
Name Time Method Mean Weekly Log-transformed Seizure Frequency During Weeks 1 Through 10 Week 1 through Week 10 Weekly seizure frequency, analyzed as mean weekly log-transformed seizure frequency \[including partial-onset seizures (POS) with or without secondary generalization, but not non-motor simple partial seizure (SPS)\] during Weeks 1 through 10.
- Secondary Outcome Measures
Name Time Method Number of Responders During Weeks 3 Through 10 Baseline and at Week 3 through Week 10 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.
Percent Change From Baseline in Mean Weekly Seizure Frequency During Weeks 1 Through 10 Baseline and at Week 1 through Week 10 Summary of percent change from Baseline in mean weekly seizure frequency is presented. Baseline was defined as the Day 0 assessment before study drug infusion. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Number of Responders During Weeks 1 Through 10 Baseline and at Week 1 through Week 10 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.
Number of Seizure-free Participants Up to Week 2 Up to Week 2 Number of seizure-free participants is presented.
Number of Seizure-free Days During Week 1 Through 10 Week 1 through Week 10 Summary of Seizure-Free days is presented.
Mean Weekly Log-transformed Seizure Frequency During Weeks 3 Through 10 Week 3 through Week 10 Weekly seizure frequency, analyzed as mean weekly log-transformed seizure frequency \[including POS with or without secondary generalization, but not non-motor SPS\] during the Weeks 3 through 10
Change From Baseline in Mean Weekly Seizure Frequency During Weeks 3 Through 10 Baseline and at Week 3 through Week 10 Summary of change from Baseline in mean weekly seizure frequency is presented. Baseline was defined as the Day 0 assessment before study drug infusion. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Percent Change From Baseline in Mean Weekly Seizure Frequency During Weeks 3 Through 10 Baseline and at Week 3 through Week 10 Summary of percent change from Baseline in mean weekly seizure frequency is presented. Baseline was defined as the Day 0 assessment before study drug infusion. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Change From Baseline in Mean Weekly Seizure Frequency During Weeks 1 Through 10 Baseline and at Week 1 through Week 10 Summary of change from Baseline in mean weekly seizure frequency is presented. Baseline was defined as the Day 0 assessment before study drug infusion. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Mean Weekly Seizure Frequency for Each Week After Dosing During Weeks 1 to 10 Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 Mean weekly Seizure Frequency for each week post-dosing During Weeks 1 to 10 is presented.
Percent Change From Baseline in Mean Weekly Seizure Frequency by Subtype During Weeks 1 Through 10 Baseline and at Week 1 through Week 10 Seizure subtypes included Complex partial seizures (CPS), Generalized tonic-clonic seizure (GTCS), and Simple partial seizure (SPS)-motor. Percent Change from Baseline in Mean Weekly Seizure frequency by seizure subtype is presented. Baseline was defined as the Day 0 assessment before study drug infusion. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Number of Seizure-free Participants During Weeks 1 Through 10 Week 1 through Week 10 Number of seizure-free participants is presented.
Number of Seizure-free Days During Week 3 Through 10 Week 3 through Week 10 Summary of Seizure-Free days is presented.
Number of Seizure-free Participants During Weeks 3 Through 10 Week 3 through Week 10 Number of seizure-free participants is presented.
Number of Seizure-free Days Up to Week 2 Up to Week 2 Summary of Seizure-Free days is presented.
Trial Locations
- Locations (27)
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 Medicine
🇺🇸Sarasota, Florida, United States
Emory HealthCare
🇺🇸Atlanta, Georgia, United States
Scroll for more (17 remaining)University of Alabama🇺🇸Birmingham, Alabama, United States