A Study of the Efficacy and Safety of Pregabalin as Add-On Therapy for Partial Onset Seizures in Children Ages 4-16 Years

Phase 3 Completed 295 enrolled Viatris Inc.

RandomizedParallel-groupTriple-blindTreatment

Summary

Study A0081041 is a double blind, placebo controlled, randomized, parallel group, multicenter study to evaluate the safety and efficacy of two dose levels of pregabalin administered in equally divided daily doses, in either capsule or oral liquid formulation, as adjunctive therapy in pediatric subjects 4 to 16 years of age with partial onset seizures.

Timeline

Start: 2011-09-27
Primary completion: 2016-08-10
Completion: 2016-08-10

Outcome

Met primary endpoint

paper A statistically significant reduction in loge(28-day seizure rate) was demonstrated with pregabalin 10 mg/kg/d (a 19.9% improvement over placebo; P = .0185). PMID 30688135 ↗

registry analysis (unspecified test); Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day vs Placebo; p = 0.0185; LS Mean Difference -0.22 (95% CI -0.41 to -0.04); ANCOVA NCT01389596 ↗

Publications

Antinew J, Pitrosky B, Knapp L, Almas M, Pitman V, Liu J, Craiu D, Modequillo M, Nordli D, Farkas V, Farkas MK. Pregabalin as Adjunctive Treatment for Focal Onset Seizures in Pediatric Patients: A Randomized Controlled Trial. J Child Neurol. 2019 Apr;34(5):248-255. doi: 10.1177/0883073818821035. Epub 2019 Jan 27.

Drugs

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