A Study of the Efficacy & Safety of Pregabalin as Add-On Therapy for

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Clinical Trial 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.

See also
Status	Clinical Trial	Phase
Completed	`NCT00275912` - Efficacy, Safety, and Tolerability of Oxcarbazepine Monotherapy in Children With Partial Seizures	Phase 4
Completed	`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	Phase 3
Completed	`NCT00275925` - Safety and Efficacy of Oxcarbazepine Monotherapy in Adults With Partial Seizures	Phase 4

NCT number	NCT01389596
Study type	Interventional
Source	Pfizer
Contact
Status	Completed
Phase	Phase 3
Start date	September 27, 2011
Completion date	August 10, 2016

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms