NCT00437281

Safety, Tolerability, and Pharmacokinetic Study of Pregabalin in Pediatric Patients With Partial Onset Seizures

A Placebo-Controlled, Escalating Dose, Multiple Dose Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of Pregabalin In Pediatric Patients With Partial Onset Seizures

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
• Sex: All
• Age: 1 Month – 16 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of multiple doses of pregabalin in pediatric patients with partial onset seizures that are incompletely controlled on their current medications.

Conditions

• Epilepsies, Partial

Interventions

Type	Name	Description
DRUG	Placebo	Placebo
DRUG	Pregabalin	Orally-administered pregabalin

Timeline

• Start date: 2007-04-01
• Primary completion: 2012-11-01
• Completion: 2012-11-01
• First posted: 2007-02-19
• Last updated: 2021-02-11
• Results posted: 2014-03-17

Locations

18 sites across 3 countries: United States, Mexico, South Korea