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- Check4 days agoChange DetectedThe study has expanded to include 12 locations, and the revision has been updated from v2.9.7 to v2.10.0.SummaryDifference0.5%
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- Check11 days agoChange DetectedThe website has been updated to Revision v2.9.7 from v2.9.6.SummaryDifference0.1%
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- Check32 days agoChange DetectedThe value 'Show more Show more Revision: v2.9.0' has recently changed to 'Show less MedlinePlus related topics: Epilepsy Seizures Drug Information available for: Ganaxolone FDA Drug and Device Resources Show less Design Details Primary Purpose : Treatment Allocation : Randomized Interventional Model : Parallel Assignment Interventional Model Description: The double-blind phase will randomize subjects to adjunctive ganaxolone or placebo at a 1:1 ratio to standard of care. Masking : Quadruple ( Participant Care Provider Investigator Outcomes Assessor ) Arms and Interventions Participant Group/Arm Intervention/Treatment Placebo Comparator : Placebo placebo suspension 3x's /day for 17 weeks Drug : Placebo inactive Other Names: Placebo (for ganaxolone) Experimental : Ganaxolone ganaxolone suspension (50 mg/ml) 3x's /day for 17 weeks Drug : Ganaxolone active drug Primary Outcome Measures Outcome Measure Measure Description Time Frame Summary of 28-day Seizure Frequency Through 17 Week Post-Baseline Phase (Median Percent Change) Summary of 28-Day Seizure Frequency for Seizure Types through 17 week Post-Baseline Phase (Median Percent Change) End of the double-blind 17 week treatment period Secondary Outcome Measures Outcome Measure Measure Description Time Frame Summary of 28-day Seizure Frequency for Subjects in the Biomarker-positive Stratum (Median Percent Change) Summary of 28-day Seizure Frequency for Seizure Types for Subjects in the Biomarker-positive Stratum through 17 weeks (Median Percent Change) [Time Frame: End of the double-blind 17 week treatment period] 50% Primary Seizure Reduction Percent of subjects experiencing a greater than or equal to 50% reduction in 28-day primary seizure frequency relative to the 12-week baseline End of the double-blind 17 week treatment period Keywords Provided by Marinus Pharmaceuticals refractory seizures epilepsy in children seizure disorder Additional Relevant MeSH Terms Brain Diseases Central Nervous System Diseases Nervous System Diseases Epilepsy Neurosteroids Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs GABA Modulators GABA Agents Anesthetics Central Nervous System Depressants Pregnanolone Ganaxolone Plan to Share Individual Participant Data (IPD)? No Studies a U.S. FDA-Regulated Drug Product Yes Studies a U.S. FDA-Regulated Device Product No Study Documents Provided by Marinus Pharmaceuticals Study Protocol [ PDF , 9.14MB, 2021-01-25 ] Statistical Analysis Plan [ PDF , 6.67MB, 2021-03-01 ] Revision: v2.9.1SummaryDifference25%
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