A Phase III Open-Label Extension Study Of Gabapentin As Adjunctive Therapy In Japanese Pediatric Patients With Partial 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: gabapentin (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
Examine the safety and efficacy of gabapentin as adjunctive therapy in Japanese pediatric
patients with partial seizures
Clinical Details
Official title: A 52 Weeks, Open-Label, Multicenter Study Evaluating The Efficacy And Safety Of Gabapentin As Adjunctive Therapy In Pediatric Patients Who Have Completed The 12 Weeks Treatment In Study A9451162
Study design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Safety (adverse events, serious adverse events, withdrawals due to adverse events, results of clinical laboratory tests)
Secondary outcome: Response Ratio, Responder Rate, Percent change in seizure frequency
Eligibility
Minimum age: 3 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Completion of study A9451162
Exclusion Criteria:
- Seizures related to drugs or acute medical illness
- History of any serious medical or psychiatric disorder
Locations and Contacts
Pfizer CT.gov Call Center, Phone: 1-800-718-1021
Pfizer Investigational Site, Kobe, Hyogo, Japan; Recruiting
Pfizer Investigational Site, Showa-Ku, Nagoya, Japan; Recruiting
Pfizer Investigational Site, Niigata-shi, Niigata, Japan; Recruiting
Pfizer Investigational Site, Okayama-shi, Okayama, Japan; Recruiting
Pfizer Investigational Site, Suita, Osaka, Japan; Recruiting
Pfizer Investigational Site, Izumi-shi, Osaka, Japan; Recruiting
Pfizer Investigational Site, Shizuoka-shi, Shizuoka, Japan; Recruiting
Pfizer Investigational Site, Shinjuku-ku, Tokyo, Japan; Not yet recruiting
Pfizer Investigational Site, Kodaira, Tokyo, Japan; Recruiting
Pfizer Investigational Site, Kiyose-shi, Tokyo, Japan; Not yet recruiting
Pfizer Investigational Site, Setagaya-ku, Tokyo, Japan; Recruiting
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: May 2008
Ending date: August 2010
Last updated: October 28, 2008
|
