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

Epilepsy, Partial Seizures Clinical Trial

Official title:
A 12-MONTH OPEN-LABEL STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF PREGABALIN AS ADJUNCTIVE 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

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Epilepsies, Partial
Epilepsy
Epilepsy, Partial Seizures
Epilepsy, Primary Generalized Tonic-Clonic Seizures
Seizures

Clinical Trial Details

NCT number	NCT01463306
Study type	Interventional
Source	Pfizer
Contact
Status	Completed
Phase	Phase 3
Start date	February 21, 2012
Completion date	August 22, 2019

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT01389596` - 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	`NCT00275912` - Efficacy, Safety, and Tolerability of Oxcarbazepine Monotherapy in Children With Partial Seizures	Phase 4
Completed	`NCT00275925` - Safety and Efficacy of Oxcarbazepine Monotherapy in Adults With Partial Seizures	Phase 4