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Safety, Tolerability, and Pharmacokinetic Study 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: Placebo (Drug); Pregabalin (Drug)

Phase: Phase 1/Phase 2

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 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.

Clinical Details

Official title: A Placebo-Controlled, Escalating Dose, Multiple Dose Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of Pregabalin In Pediatric Patients With Partial Onset Seizures

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety Study

Primary outcome: Frequency and severity of adverse events; physical and neurologic exams;vital signs; ECGs; laboratory tests; seizure frequency throughout the 8 day study period.

Secondary outcome: Pharmacokinetic endpoints (Cmax, Tmax, AUC, Clearance, T 1/2) at Day 8.

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

Exclusion Criteria:

- Primary generalized seizures

- Progressive CNS pathology

Locations and Contacts

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

Pfizer Investigational Site, Jonesboro, Arkansas 72401, United States; Recruiting

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

Pfizer Investigational Site, Costa Mesa, California 92626, United States; Not yet recruiting

Pfizer Investigational Site, Riverside, California 92506, United States; Not yet 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, Orlando, Florida 32819, United States; 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 2009
Last updated: October 27, 2008

Page last updated: November 03, 2008

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