This study will assess the efficacy and safety of BGG492 as adjunctive treatment in patients with partial onset seizures.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
93
To detect a dose-response by measuring the percent change in seizure frequency of BGG492 from baseline to maintenance period.
Time frame: 28 days
To evaluate the efficacy of BGG492 compared to placebo as a change in seizure frequency from baseline period to 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.
Time frame: 12 weeks
Pharmacokinetic profile of BGG492
Time frame: 10 weeks
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Barrow Neurological Clinics at St. Joseph's Hospital and MC
Phoenix, Arizona, United States
Center for Neurosciences
Tucson, Arizona, United States
Clinical Trials, Inc.
Little Rock, Arkansas, United States
Medical Center of the Rockies
Loveland, Colorado, United States
AMO Corporation
Tallahassee, Florida, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
Investigative Site - Private Practice
Ocean Springs, Mississippi, United States
St.John's Research Institute, Inc
Springfield, Missouri, United States
Renown Institute for Neurosciences
Reno, Nevada, United States
NJ to Capital Health in Hamilton
Somerset, New Jersey, United States
...and 41 more locations