drugset / Trial / NCT01463306

A 12-Month Study To Evaluate The Safety And Tolerability Of Pregabalin As Add-On Therapy In Pediatric Subjects 1 Month To 16 Years Of Age With Partial Onset Seizures And Pediatric And Adult Subjects 5 To 65 Years Of Age With Primary Generalized Tonic-Clonic Seizures

NCT01463306

Phase 3 Completed 605 enrolled Viatris Inc.
NaOpen-labelTreatment

Summary

Study A0081106 is a 12-month open-label study to evaluate the long term safety and tolerability of pregabalin as add-on therapy in pediatric subjects 1 month to 16 years of age with partial onset seizures and pediatric and adult subjects 5 to 65 years of age with primary generalized tonic-clonic seizures. Pregabalin will be administered in equally divided daily doses for 1 year, in either capsule or liquid oral formulation.

Timeline

Start
2012-02-21
Primary completion
2019-08-22
Completion
2019-08-22

Drugs

EvaluationDrugModalityDoseRoute
Subject Pregabalin Small molecule 2.5 mg/kg Oral
Subject Pregabalin Small molecule 10 mg/kg Oral
Subject Pregabalin Small molecule 150 mg Oral
Subject Pregabalin Small molecule 600 mg Oral