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.

Trial Profile

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.

Completed
Phase of Trial: Phase III

Latest Information Update: 28 Apr 2017

At a glance

  • Drugs Topiramate (Primary)
  • Indications Partial epilepsies
  • Focus Adverse reactions
  • Acronyms PREVAIL OLE
  • Sponsors Upsher-Smith
  • Most Recent Events

    • 28 Apr 2017 Results assessing efficacy and safety of USL255 and other second-generation antiepileptic drugs using patient data from PREVAIL, PREVAIL OLE and one more study (Guberman et al, 2002), presented at the 69th Annual Meeting of the American Academy of Neurology
    • 21 Apr 2016 Results of pooled analysis from three phase I and two phase III studies assessing the differentiating features of Topiramate (extented release capsules and immediate release) presented at the 68th Annual Meeting of the American Academy of Neurology
    • 21 Apr 2016 Post-hoc efficacy analysis of this PREVAIL OLE trial were presented at the 68th Annual Meeting of the American Academy of Neurology.
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