Clinical trial NCT00620555: A Phase III Open-Label Extension Study Of Gabapentin As Adjunctive Therapy In Japanese Pediatric Patients With Partial Seizures
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 (NCT00603473)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Epilepsies, Partial
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-02-21
Enrollment: 65
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Examine the safety and efficacy of gabapentin as adjunctive therapy in Japanese pediatric patients with partial seizures


Eligibility criteria: Inclusion Criteria:

* Completion of study A9451162 (NCT00603473)

Exclusion Criteria:

* Seizures related to drugs or acute medical illness
* History of any serious medical or psychiatric disorder

Primary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-Related)
timeFrame: up to 53 weeks
Secondary outcomes:
measure: Response Ratio
timeFrame: Up to 52 weeks
measure: Responder Rate
timeFrame: Up to 52 weeks
measure: Percent Change in Seizure Frequency
timeFrame: Up to 52 weeks
Other outcomes:
Locations:
city: Obu-shi,Morioka-machi
country: Japan
facility: Pfizer Investigational Site
state: Aichi
city: Jonan-ku
country: Japan
facility: Pfizer Investigational Site
state: Fukuoka
city: Kobe
country: Japan
facility: Pfizer Investigational Site
state: Hyogo
city: Suma-Ku,Kobe
country: Japan
facility: Pfizer Investigational Site
state: Hyogo
city: Kanazawa
country: Japan
facility: Pfizer Investigational Site
state: Ishikawa
city: Zentsuuji
country: Japan
facility: Pfizer Investigational Site
state: Kagawa
city: Yokohama
country: Japan
facility: Pfizer Investigational Site
state: Kanagawa Pref.
city: Sendai-shi
country: Japan
facility: Pfizer Investigational Site
state: Miyagi-ken
city: Showa-Ku
country: Japan
facility: Pfizer Investigational Site
state: Nagoya
city: Niigata-shi
country: Japan
facility: Pfizer Investigational Site
state: Niigata
city: Kurashiki-City
country: Japan
facility: Pfizer Investigational Site
state: Okayama Pref.
city: Okayama-shi
country: Japan
facility: Pfizer Investigational Site
state: Okayama
city: Izumi-shi
country: Japan
facility: Pfizer Investigational Site
state: Osaka
city: Miyakojima-ku
country: Japan
facility: Pfizer Investigational Site
state: Osaka
city: Suita
country: Japan
facility: Pfizer Investigational Site
state: Osaka
city: Shizuoka-shi
country: Japan
facility: Pfizer Investigational Site
state: Shizuoka
city: Kodaira
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Setagaya-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Hiroshima
country: Japan
facility: Pfizer Investigational Site
city: Saitama
country: Japan
facility: Pfizer Investigational Site
city: Yamagata
country: Japan
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: