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A Phase III Open-Label Extension Study Of Gabapentin As Adjunctive Therapy In Japanese Pediatric Patients With Partial Seizures | Clinical Trials | Clareo Health

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A Phase III Open-Label Extension Study Of Gabapentin As Adjunctive Therapy In Japanese Pediatric Patients With Partial Seizures

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)

NCT00620555•Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

3 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (22)

Pfizer Investigational Site

Obu-shi,Morioka-machi, Aichi-ken, Japan

Pfizer Investigational Site

Jonan-ku, Fukuoka, Japan

Pfizer Investigational Site

Kobe, Hyōgo, Japan

Pfizer Investigational Site

Suma-Ku,Kobe, Hyōgo, Japan

Pfizer Investigational Site

Kanazawa, Ishikawa-ken, Japan

Pfizer Investigational Site

Zentsuuji, Kagawa-ken, Japan

Pfizer Investigational Site

Yokohama, Kanagawa Pref., Japan

Pfizer Investigational Site

Sendai, Miyagi, Japan

Pfizer Investigational Site

Shōwaku, Nagoya, Japan

Pfizer Investigational Site

Niigata, Niigata, Japan

Key Dates

Start Date

May 1, 2008

Primary Completion Date

December 1, 2010

Completion Date

December 1, 2010

Last Updated

February 3, 2021

Enrollment

ACTUAL participants

Conditions

Epilepsies, Partial

Interventions

gabapentin

DRUG

Contribution of Genetics, Non-invasive Methods and Neuropsychology in Focal Cryptogenic Epilepsies

NCT05015868

Epilepsies, PartialEpilepsy Intractable

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COMPLETED

Cerebral Oxygen Saturation and Cytochrome Oxidase REDOX State in Children With Epilepsy: A Pilot Study

NCT03054961

Epilepsies, Partial

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NOT_YET_RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 3, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Phase III Open-Label Extension Study Of Gabapentin As Adjunctive Therapy In Japanese Pediatric Patients With Partial Seizures

Inclusion Criteria

Exclusion Criteria

Contribution of Genetics, Non-invasive Methods and Neuropsychology in Focal Cryptogenic Epilepsies

Cerebral Oxygen Saturation and Cytochrome Oxidase REDOX State in Children With Epilepsy: A Pilot Study

Real-world Study of Efficacy and Safety of Zonisamide in add-on Therapy for Patients With Focal Epilepsy

Microburst Vagus Nerve Stimulator (VNS) Therapy Feasibility Study

Study of the Efficacy of the Treatment of Sleep Apnea Syndrome by CPAP in Pharmacoresistant Epilepsy

Safety, Tolerability, and Pharmacokinetic Study of Pregabalin in Pediatric Patients With Partial Onset Seizures