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

Information source: Pfizer
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Epilepsies, Partial

Intervention: Pregabalin (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021

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.

Clinical Details

Official title: A 12-Month Open-Label Extension Study Evaluating The Safety And Tolerability Of Flexible Doses Of Pregabalin In Pediatric Patients With Partial Onset Seizures

Study design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study

Primary outcome: Frequency and severity of adverse events, which will be evaluated at every visit throughout the 12 month study period.

Secondary outcome: Physical and neurologic exams, vital signs, growth parameters, ECGs, laboratory tests, and seizure frequency, all of which will be evaluated throughout the 12 month study period.

Eligibility

Minimum age: 1 Month. Maximum age: 16 Years. Gender(s): Both.

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

Locations and Contacts

Pfizer CT.gov Call Center, Phone: 1-800-718-1021

Pfizer Investigational Site, Little Rock, Arkansas 72205, United States; Recruiting

Pfizer Investigational Site, Gulf Breeze, Florida 32561, United States; Recruiting

Pfizer Investigational Site, Tampa, Florida 33603, United States; Recruiting

Pfizer Investigational Site, Tampa, Florida 33609, United States; Recruiting

Pfizer Investigational Site, Miami, Florida 33155, United States; Not yet recruiting

Pfizer Investigational Site, Chicago, Illinois 60614, United States; Not yet recruiting

Pfizer Investigational Site, Buffalo, New York 14222, United States; Recruiting

Pfizer Investigational Site, San Antonio, Texas 78258, United States; Recruiting

Pfizer Investigational Site, Richmond, Virginia 23219, United States; Not yet recruiting

Pfizer Investigational Site, Richmond, Virginia 23298, United States; Not yet recruiting

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: March 2007
Ending date: July 2010
Last updated: October 27, 2008

Page last updated: November 03, 2008

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