At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 210 enrolled
Drug / intervention
USL255drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Open-Label Extension Study to Evaluate the Safety of USL255 as Adjunctive Therapy in Patients With Refractory Partial-Onset Seizures Who Had Participated in P09-004, a Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study
In Brief
A Phase 3 clinical trial evaluating USL255 for Epilepsy. Completed, enrolled 210 participants across 68 sites in 15 countries.
Detailed Summary
The purpose of this study is to examine the safety of USL255 as adjunctive therapy in patients with refractory partial onset-seizures.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpilepsy
CountriesArgentina, Australia, Belgium, Canada, Chile, Germany, Greece, India, Israel, New Zealand, Poland, Russia, South Africa, Spain, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedAug 2010
Enrollment StartOct 2010
Primary CompletionMay 2014
TodayJul 2026
First PostedAug 30, 2010
Enrollment StartOct 1, 2010
Primary CompletionMay 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 15.8 years ago
Interventions
USL255drug