Clinical trial NCT00603473: A Phase III Open-Label Study 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Epilepsies, Partial
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-01-29
Enrollment: 92
Sex: ALL
Minimum age (years): 3
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Response Ratio of Gabapentin in Japanese Pediatric Patients With Partial Seizures
timeFrame: 12 weeks
Secondary outcomes:
measure: Responder Rate
timeFrame: 12 weeks
measure: Percent Change in Seizure Frequency (PCH)
timeFrame: 12 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: Sapporo
country: Japan
facility: Pfizer Investigational Site
state: Hokkaido
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: Higashimatsuyama
country: Japan
facility: Pfizer Investigational Site
state: Saitama
city: Shizuoka-shi
country: Japan
facility: Pfizer Investigational Site
state: Shizuoka
city: Kiyose-shi
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
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
city: Yamanashi
country: Japan
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: