A Phase III Open-Label Study Of Gabapentin As Adjunctive Therapy In Japanese Pediatric Patients With Partial Seizures

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

Examine the efficacy, safety and pharmacokinetics of gabapentin as adjunctive therapy in Japanese pediatric patients with partial seizures

Official title: An Open-Label, Multicenter Study Evaluating, The Efficacy, Safety And Pharmacokinetics Of Gabapentin As Adjunctive Therapy In Pediatric Patients With Partial Seizures When Other Antiepileptics Do Not Provide Satisfactory Effects

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

Primary outcome: To confirm Response Ratio of Gabapentin in Japanese pediatric patients with partial seizures

Secondary outcome:

Responder Rate, Percent change in seizure frequency, Pharmacokinetics

Safety

Minimum age: 3 Years. Maximum age: 15 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Japanese male or females, ages 3-15 years old at acquisition of informed consent, 15

years old or less at the baseline visit

- Seizures are classified as simple partial, complex partial or partial becoming

secondarily generalized (defined according to the International League Against Epilepsy)

- Have not been able to achieve adequate seizure control with antiepileptic drugs

Exclusion Criteria:

- Seizures related to drugs or acute medical illness

- History of any serious medical or psychiatric disorder

- Diagnosis or history of a structural CNS lesion or an encephalopathy shown to be

progressive

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

Pfizer Investigational Site, yamanashi, Japan; Recruiting

Pfizer Investigational Site, Hiroshima, Japan; Completed

Pfizer Investigational Site, Saitama, Japan; Recruiting

Pfizer Investigational Site, Yamagata, Japan; Active, not recruiting

Pfizer Investigational Site, Obu-shi,Morioka-machi, Aichi, Japan; Active, not recruiting

Pfizer Investigational Site, Jonan-ku, Fukuoka, Japan; Completed

Pfizer Investigational Site, Sapporo, Hokkaido, Japan; Recruiting

Pfizer Investigational Site, Sapporo, Hokkaido, Japan; Not yet recruiting

Pfizer Investigational Site, Kobe, Hyogo, Japan; Recruiting

Pfizer Investigational Site, Suma-Ku, Kobe, Hyogo, Japan; Recruiting

Pfizer Investigational Site, Kanazawa, Ishikawa, Japan; Active, not recruiting

Pfizer Investigational Site, zentsuuji, Kagawa, Japan; Recruiting

Pfizer Investigational Site, Yokohama, Kanagawa Pref., Japan; Recruiting

Pfizer Investigational Site, Sendai-shi, Miyagi-ken, Japan; Active, not recruiting

Pfizer Investigational Site, Showa-Ku, Nagoya, Japan; Completed

Pfizer Investigational Site, Niigata-shi, Niigata, Japan; Completed

Pfizer Investigational Site, Okayama-shi, Okayama, Japan; Recruiting

Pfizer Investigational Site, Kurashiki-City, Okayama Pref., Japan; Recruiting

Pfizer Investigational Site, Suita, Osaka, Japan; Completed

Pfizer Investigational Site, Izumi-shi, Osaka, Japan; Completed

Pfizer Investigational Site, miyakojima-ku, Osaka, Japan; Recruiting

Pfizer Investigational Site, Higashimatsuyama, Saitama, Japan; Recruiting

Pfizer Investigational Site, Shizuoka-shi, Shizuoka, Japan; Recruiting

Pfizer Investigational Site, Shinjuku-ku, Tokyo, Japan; Recruiting

Pfizer Investigational Site, Kodaira, Tokyo, Japan; Active, not recruiting

Pfizer Investigational Site, Kiyose-shi, Tokyo, Japan; Completed

Pfizer Investigational Site, Setagaya-ku, Tokyo, Japan; Completed

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

Starting date: January 2008
Ending date: January 2010
Last updated: October 8, 2009