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

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 605 (actual)
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
• Sex: All
• Age: 1 Month – 66 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	Pregabalin	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.

Timeline

• Start date: 2012-02-21
• Primary completion: 2019-08-22
• Completion: 2019-08-22
• First posted: 2011-11-01
• Last updated: 2021-01-20
• Results posted: 2020-02-21

Locations

151 sites across 31 countries: United States, Belarus, 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

Regulatory

• FDA-regulated drug study