Evaluation of the safety and efficacy of Oxcarbazepine XR as adjunctive treatment for adults with partial onset seizures
Multicenter, double-blind, randomized, placebo-controlled, three-arm. parallel-group study of the efficacy and safety of extended-release oxcarbazepine in the treatment of adults with refractory partial onset epilepsy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
366
Non-active tablet identical to study drug tablets
tablets containing 600mg OXC XR, identical to non-active tablets
two active tablets and two non-active tablets, all identical
PCH(T), ITT
Percent change (PCH) in seizure frequency per 28d relative to Baseline, Treatment Phase (PCH\[T\]), Intent-to-Treat population.
Time frame: Change at 16 weeks (4wks Titration + 12 wks Maintenance) compared to Baseline
PCH(M)- ITT
Percent change in seizure frequency per 28 days relative to Baseline, Maintenance Period (PCH\[M\]), Intent-to-Treat population
Time frame: Change at 12 weeks (Maintenance Period) compared to Baseline
Responder Rate, ITT
Percent of patients with a positive response, defined as a 50% or greater reduction in seizure frequency per 28 days relative to Baseline, Treatment Phase, Intent-to-Treat population
Time frame: At the end of 16 weeks (4 wks Titration + 12 wks Maintenance)
Seizure-Free Rates, ITT
Percent of patients seizure-free during Treatment Phase, Intent-to-Treat population
Time frame: At the end of 16 weeks (4 wks Titration + 12 wks Maintenance)
Seizure Free Rate, ITT, (M)
Percent of patients seizure-free during Maintenance, Intent-to-Treat population
Time frame: At the end of 12 weeks (Maintenance Period)
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Huntsville, Alabama, United States
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Northport, Alabama, United States
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Phoenix, Arizona, United States
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Tucson, Arizona, United States
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Little Rock, Arkansas, United States
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Riverside, California, United States
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West Los Angeles, California, United States
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Aurora, Colorado, United States
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Jacksonville, Florida, United States
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Miami, Florida, United States
...and 61 more locations