Safety, Tolerability, and Pharmacokinetic Study of Pregabalin in Pediatric Patients With Partial Onset Seizures

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Epilepsies, Partial

In brief

The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of multiple doses of pregabalin in pediatric patients with partial onset seizures that are incompletely controlled on their current medications.

Key facts

Study ID

NCT00437281

Run by

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

People needed

65

Starts

2007-04-01

Expected to finish

2012-11-01

Last updated by the study team

2021-02-11

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

You may not qualify if…

• Primary generalized seizures
• Progressive CNS pathology

Where it is running

• Pfizer Investigational Site — Mobile, Alabama, United States
• Pfizer Investigational Site — Mobile, Alabama, United States
• Pfizer Investigational Site — Phoenix, Arizona, United States
• Pfizer Investigational Site — Jonesboro, Arkansas, United States
• Pfizer Investigational Site — Little Rock, Arkansas, United States
• Pfizer Investigational Site — San Francisco, California, United States
• Pfizer Investigational Site — Gulf Breeze, Florida, United States
• Pfizer Investigational Site — Pensacola, Florida, United States
• Pfizer Investigational Site — Tampa, Florida, United States
• Pfizer Investigational Site — Tampa, Florida, United States
• Pfizer Investigational Site — Springfield, Missouri, United States
• Pfizer Investigational Site — Buffalo, New York, United States
• Pfizer Investigational Site — Durham, North Carolina, United States
• Pfizer Investigational Site — Houston, Texas, United States
• Pfizer Investigational Site — San Antonio, Texas, United States
• Pfizer Investigational Site — Guadalajara, Jalisco, Mexico
• Pfizer Investigational Site — Mexico City, Mexico City, Mexico
• Pfizer Investigational Site — Seoul, South Korea

Full record on ClinicalTrials.gov

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