This study will assess the efficacy of BGG492 as adjunctive treatment in patients with refractory partial onset seizures
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
University of South Alabama
Mobile, Alabama, United States
Johns Hopkins Hospital
Seizure counts, documenting the percent change in seizure frequency of BGG492 in the maintenance period.
Time frame: 28 days
Responder rate: analysis of patients with a 50% or greater reduction in seizure frequency of BGG492 during the maintenance period.
Time frame: 28 days
Safety and tolerability of BGG492 compared to placebo evaluated by continuous adverse event monitoring and assessment of vital signs and ECGs at each visit and laboratory assessments every 2 to 4 weeks
Time frame: 12 weeks
Pharmacokinetic profile of BGG492 including plasma concentrations of BGG492 at each dose level and derived variables including AUC (area under the curve), Cmax (maximum plasma concentration), Tmax (time to maximum concentration), T1/2 (half life.)
Time frame: 10 weeks
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Baltimore, Maryland, United States
Epilepsy Care Specialists, S.C.
Milwaukee, Wisconsin, United States
Novartis Investigative Site
Salzburg, Austria
Novartis Investigative Site
Vienna, Austria
Novartis Investigational Site
Vienna, Austria
Novartis Investigative Site
Duffel, Belgium
Novartis Investigative Site
Ottignies, Belgium
Novartis Investigative Site
Sofia, Bulgaria
Novartis Investigative Site
Greenfield Park, Quebec, Canada
...and 13 more locations