A Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study of the Efficacy and Safety of Pregabalin As Adjunctive Therapy in Children 4 -16 Years of Age With Partial Onset Seizures

Trial Profile

A Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study of the Efficacy and Safety of Pregabalin As Adjunctive Therapy in Children 4 -16 Years of Age With Partial Onset Seizures

Completed
Phase of Trial: Phase III

Latest Information Update: 26 Apr 2017

At a glance

  • Drugs Pregabalin (Primary)
  • Indications Partial epilepsies
  • Focus Registrational; Therapeutic Use
  • Acronyms PERIWINKLE
  • Sponsors Pfizer
  • Most Recent Events

    • 01 Dec 2016 Primary endpoint has not been met. (Log transformed (loge) 28 day seizure rate for all partial onset seizures collected during the 12 week double-blind treatment phase, reported as percent reduction in seizures relative to placebo. [ Time Frame: 12 weeks ] For Dose 2.5 mg/kg/day), as reported in a Pfizer media release.
    • 01 Dec 2016 Primary endpoint has been met. (Log transformed (loge) 28 day seizure rate for all partial onset seizures collected during the 12 week double-blind treatment phase, reported as percent reduction in seizures relative to placebo. [ Time Frame: 12 weeks ] For Dose 10 mg/kg/day), as reported in a Pfizer media release.
    • 01 Dec 2016 Status changed from active, no longer recruiting to completed, according to a Pfizer media release.
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