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

Completed · Phase 3

Conditions studied: Epilepsies, Partial

In brief

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.

Key facts

Study ID

NCT00448916

Run by

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

People needed

54

Starts

2007-05-01

Expected to finish

2013-10-01

Last updated by the study team

2021-01-25

Who can join

Age: 0 and older, up to 16. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Partial onset seizures, incompletely controlled on 1-3 medications
• At least 1 seizure per 28 days, on average
• Completion of study A0081074

You may not qualify if…

• Primary generalized seizures
• Progressive CNS pathology
• Failure to tolerate pregabalin in study A0081074

Where it is running

• University of South Alabama — Mobile, Alabama, United States
• University of South Alabama Department of Neurology — Mobile, Alabama, United States
• Phoenix Children's Hospital — Phoenix, Arizona, United States
• The Children's Clinica of Jonesboro, P.A — Jonesboro, Arkansas, United States
• Clinical Study Centers, L. L. C. — Little Rock, Arkansas, United States
• UCSF Neurology Clinic — San Francisco, California, United States
• Child Neurology Center of Northwest Florida — Gulf Breeze, Florida, United States
• The Office of Sergio J Jacinto, MD — Tampa, Florida, United States
• Pediatric Epilepsy & Neurology Specialists — Tampa, Florida, United States
• St. John's Clinic — Springfield, Missouri, United States
• St. John's Hospital — Springfield, Missouri, United States
• Women and Children's Hospital of Buffalo — Buffalo, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Baylor College of Medicine - Texas Children's Hospital — Houston, Texas, United States
• Texas Children's Hospital — Houston, Texas, United States
• Road Runner Research, Ltd. — San Antonio, Texas, United States
• Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde — Guadalajara, Jalisco, Mexico
• Yonsei University College of Medicine Severance Hospital / Department of Pediatric Neurology — Seoul, South Korea

Full record on ClinicalTrials.gov

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