Status:
COMPLETED
Open-Label Extension Study Of Safety And Tolerability 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:
PHASE3
Brief 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.
Eligibility Criteria
Inclusion
- Partial onset seizures, incompletely controlled on 1-3 medications
- At least 1 seizure per 28 days, on average
- Completion of study A0081074
Exclusion
- Primary generalized seizures
- Progressive CNS pathology
- Failure to tolerate pregabalin in study A0081074
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT00448916
Start Date
May 1 2007
End Date
October 1 2013
Last Update
January 25 2021
Active Locations (18)
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1
University of South Alabama
Mobile, Alabama, United States, 36604
2
University of South Alabama Department of Neurology
Mobile, Alabama, United States, 36693
3
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
4
The Children's Clinica of Jonesboro, P.A
Jonesboro, Arkansas, United States, 72401