Open-Label Extension Study Of Safety And Tolerability Of Pregabalin In Pediatric Patients With Partial-Onset Seizures

• Status: Completed
• Trial end date: 2013-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The study will evaluate the long-term safety and tolerability of pregabalin in pediatric patients, age 1 month through 16 years, with partial onset seizures.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer; Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Treatments: Pregabalin

Criteria

Inclusion Criteria:

• Partial onset seizures, incompletely controlled on 1-3 medications

• At least 1 seizure per 28 days, on average

• Completion of study A0081074

Exclusion Criteria:

• Primary generalized seizures

• Progressive CNS pathology

• Failure to tolerate pregabalin in study A0081074