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
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