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”

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

Study Type: Interventional

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

Study Primary Completion Date: August 2009

Intervention(s) in this Clinical Trial

• Drug: gabapentin
  • Orally administered gabapentin

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: gabapentin

Primary Measures

• To confirm Response Ratio of Gabapentin in Japanese pediatric patients with partial seizures
  • Time Frame: 12 weeks
    Safety Issue?: No

Secondary Measures

• Responder Rate, Percent change in seizure frequency, Pharmacokinetics
  • Time Frame: 12 weeks
    Safety Issue?: No
• Safety
  • Time Frame: 12 weeks
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 3 Years

Maximum Age for this Clinical Trial: 15 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Overall Contact: Pfizer CT.gov Call Center 1-800-718-1021 

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00603473

Study ID Number: A9451162

ClinicalTrials.gov Identifier: NCT00603473

Health Authority: Japan: Ministry of Health, Labor and Welfare

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