A Phase III Open-Label Extension Study Of Gabapentin As Adjunctive Therapy In Japanese Pediatric Patients With Partial Seizures
Examine the safety and efficacy of gabapentin as adjunctive therapy in Japanese pediatric patients with partial...
Brief Summary
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)”
Examine the safety and efficacy of gabapentin as adjunctive therapy in Japanese pediatric patients with partial seizures
- Study Type: Interventional
- Study Design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
- Study Primary Completion Date: December 2010
Intervention(s) in this Clinical Trial
- Drug: gabapentin
- Orally administered gabapentin
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: gabapentin
Outcome Measures for this Clinical Trial
Primary Measures
- Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-Related)
- Time Frame: up to 53 weeks
Safety Issue?: Yes
- Time Frame: up to 53 weeks
Secondary Measures
- Response Ratio
- Time Frame: Up to 52 weeks
Safety Issue?: No
- Time Frame: Up to 52 weeks
- Responder Rate
- Time Frame: Up to 52 weeks
Safety Issue?: No
- Time Frame: Up to 52 weeks
- Percent Change in Seizure Frequency
- Time Frame: Up to 52 weeks
Safety Issue?: No
- Time Frame: Up to 52 weeks
Criteria for Participation in this Clinical Trial
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
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
Clinical Trial Investigator Information
Lead Investigator: Pfizer Industry
Overall Clinical Trial Officials and Contacts
Pfizer CT.gov Call Center Study Director Pfizer
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
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
To obtain contact information for a study center near you, click here.
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00620555
