CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 605 enrolled
Drug / intervention
Pregabalindrug
Likely dose
Pregabalin 2.5 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01463306
NCT01463306Phase 3Completed
CompareCT.gov

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

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.·interventional·Posted Nov 1, 2011·Updated Jan 20, 2021

In Brief

A Phase 3 clinical trial evaluating Pregabalin for Epilepsy, Partial Seizures and Epilepsy, Primary Generalized Tonic-Clonic Seizures. Completed, enrolled 605 participants across 151 sites in 31 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpilepsy, Partial Seizures, Epilepsy, Primary Generalized Tonic-Clonic Seizures
CountriesBelarus, Belgium, Bosnia and Herzegovina, Bulgaria, China, Czechia, France, Germany, Greece, Hungary, India, Israel, Italy, Lebanon, Malaysia, Montenegro, Philippines, Poland, Romania, Russia, Serbia, Singapore, Slovakia, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), Ukraine, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedNov 1, 2011
Enrollment StartFeb 21, 2012
Primary CompletionAug 22, 2019
TodayJul 2, 2026
Enrollment to primary: 7.5 yearsPosted 14.7 years ago

Interventions

Pregabalindrug

Pregabalin administered as either capsule or liquid oral formulations. Subjects \<4 years of age at Visit 1 will receive study medication 3 times daily (TID) in equally divided doses. Subjects who are ≥4 years of age at Visit 1 will receive study medication twice daily (BID) in equally divided doses. Children less than 17 years of age will receive from 2.5 mg/kg/day to 10.0 mg/kg/day (maximum 600 mg/day. Adults 17 and older will receive from 150 mg/day to 600 mg/day.