Status:

COMPLETED

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

Lead Sponsor:

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

Conditions:

Epilepsies, Partial

Eligibility:

All Genders

3+ years

Phase:

PHASE3

Brief Summary

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

Eligibility Criteria

Inclusion

  • Completion of study A9451162 (NCT00603473)

Exclusion

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

Key Trial Info

Start Date :

May 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2010

Estimated Enrollment :

65 Patients enrolled

Trial Details

Trial ID

NCT00620555

Start Date

May 1 2008

End Date

December 1 2010

Last Update

February 3 2021

Active Locations (22)

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Page 1 of 6 (22 locations)

1

Pfizer Investigational Site

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

2

Pfizer Investigational Site

Jonan-ku, Fukuoka, Japan

3

Pfizer Investigational Site

Kobe, Hyōgo, Japan

4

Pfizer Investigational Site

Suma-Ku,Kobe, Hyōgo, Japan