Status:
COMPLETED
Safety, Tolerability, and Pharmacokinetic Study of Pregabalin in Pediatric Patients With Partial Onset Seizures
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Epilepsies, Partial
Eligibility:
All Genders
1-16 years
Phase:
PHASE1
PHASE2
Brief Summary
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 controlle...
Eligibility Criteria
Inclusion
- Partial onset seizures, incompletely controlled on 1-3 medications
- At least 1 seizure per 28 days, on average
Exclusion
- Primary generalized seizures
- Progressive CNS pathology
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT00437281
Start Date
April 1 2007
End Date
November 1 2012
Last Update
February 11 2021
Active Locations (18)
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1
Pfizer Investigational Site
Mobile, Alabama, United States, 36604
2
Pfizer Investigational Site
Mobile, Alabama, United States, 36693
3
Pfizer Investigational Site
Phoenix, Arizona, United States, 85016
4
Pfizer Investigational Site
Jonesboro, Arkansas, United States, 72401