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”

Examine the safety and efficacy 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, Safety/Efficacy Study

Study Primary Completion Date: August 2010

Intervention(s) in this Clinical Trial

• Drug: gabapentin
  • Orally administered gabapentin

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: gabapentin

Primary Measures

• Safety (adverse events, serious adverse events, withdrawals due to adverse events, results of clinical laboratory tests)
  • Time Frame: 52 weeks
    Safety Issue?: Yes

Secondary Measures

• Response Ratio, Responder Rate, Percent change in seizure frequency
  • Time Frame: 52 weeks
    Safety Issue?: No

Inclusion Criteria:

• Completion of study A9451162

Exclusion Criteria:

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 3 Years

Maximum Age for this Clinical Trial: N/A

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/NCT00620555

Study ID Number: A9451165

ClinicalTrials.gov Identifier: NCT00620555

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

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