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

NCT ID: NCT00603473

Last Updated: 2021-02-03

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2009-12-31

Brief Summary

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

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Detailed Description

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Conditions

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Epilepsies, Partial

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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gabapentin

Group Type EXPERIMENTAL

gabapentin

Intervention Type DRUG

Orally administered gabapentin

Interventions

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gabapentin

Orally administered gabapentin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

3 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

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

Site Status

Pfizer Investigational Site

Jonan-ku, Fukuoka, Japan

Site Status

Pfizer Investigational Site

Sapporo, Hokkaido, Japan

Site Status

Pfizer Investigational Site

Kobe, Hyōgo, Japan

Site Status

Pfizer Investigational Site

Suma-Ku, Kobe, Hyōgo, Japan

Site Status

Pfizer Investigational Site

Kanazawa, Ishikawa-ken, Japan

Site Status

Pfizer Investigational Site

Zentsuuji, Kagawa-ken, Japan

Site Status

Pfizer Investigational Site

Yokohama, Kanagawa Pref., Japan

Site Status

Pfizer Investigational Site

Sendai, Miyagi, Japan

Site Status

Pfizer Investigational Site

Shōwaku, Nagoya, Japan

Site Status

Pfizer Investigational Site

Niigata, Niigata, Japan

Site Status

Pfizer Investigational Site

Kurashiki, Okayama Pref., Japan

Site Status

Pfizer Investigational Site

Okayama, Okayama-ken, Japan

Site Status

Pfizer Investigational Site

Izumi-shi, Osaka, Japan

Site Status

Pfizer Investigational Site

Miyakojima-ku, Osaka, Japan

Site Status

Pfizer Investigational Site

Suita, Osaka, Japan

Site Status

Pfizer Investigational Site

Higashi-Matsuyama, Saitama, Japan

Site Status

Pfizer Investigational Site

Shizuoka, Shizuoka, Japan

Site Status

Pfizer Investigational Site

Kiyose-shi, Tokyo, Japan

Site Status

Pfizer Investigational Site

Kodaira, Tokyo, Japan

Site Status

Pfizer Investigational Site

Setagaya-ku, Tokyo, Japan

Site Status

Pfizer Investigational Site

Shinjuku-ku, Tokyo, Japan

Site Status

Pfizer Investigational Site

Hiroshima, , Japan

Site Status

Pfizer Investigational Site

Saitama, , Japan

Site Status

Pfizer Investigational Site

Yamagata, , Japan

Site Status

Pfizer Investigational Site

Yamanashi, , Japan

Site Status

Countries

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Japan

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A9451162&StudyName=A%20Phase%20III%20Open-Label%20Study%20Of%20Gabapentin%20As%20Adjunctive%20Therapy%20In%20Japanese%20Pediatric%20Patients%20With%20Partial%20Seizures

To obtain contact information for a study center near you, click here.

Other Identifiers

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A9451162

Identifier Type: -

Identifier Source: org_study_id

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