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
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 19 Jan 2022
Price :
$35
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At a glance
- Drugs Pregabalin (Primary)
- Indications Partial epilepsies
- Focus Registrational; Therapeutic Use
- Acronyms PERIWINKLE
- Sponsors Pfizer
Most Recent Events
- 05 Dec 2020 Results of pooled analysis of pregabalin concentration and efficacy data (from 10 studies) assessing population pharmacokinetic and exposure-response analyses, to compare pregabalin exposure and E-R relationships in pediatric and adult patients with FOS, published in the Clinical Pharmacology and Therapeutics
- 05 Dec 2017 Results presented at the 71st Annual Meeting of the American Epilepsy Society
- 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.