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

Phase 1/2 Completed 65 enrolled Viatris Inc.

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start: 2007-04
Primary completion: 2012-11
Completion: 2012-11

Publications

Mann D, Liu J, Chew ML, Bockbrader H, Alvey CW, Zegarac E, Pellock J, Pitman VW. Safety, tolerability, and pharmacokinetics of pregabalin in children with refractory partial seizures: a phase 1, randomized controlled study. Epilepsia. 2014 Dec;55(12):1934-43. doi: 10.1111/epi.12830. Epub 2014 Nov 6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pregabalin	Small molecule	2.5 mg/kg	Oral
Subject	Pregabalin	Small molecule	5 mg/kg	Oral
Subject	Pregabalin	Small molecule	10 mg/kg	Oral
Subject	Pregabalin	Small molecule	15 mg/kg	Oral

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

Summary

Timeline

Publications

Drugs

Indications