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

Primary Purpose

Epilepsies, Partial

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
gabapentin
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsies, Partial

Eligibility Criteria

3 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

gabapentin

Arm Description

Outcomes

Primary Outcome Measures

Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-Related)
Any untoward medical occurrence in a participant who received study drug was considered an adverse event (AE), without regard to possibility of causal relationship. Treatment-emergent adverse events: those which occurred or worsened after baseline. Severe AEs: those which interferes significantly with participant's usual function. An AE resulting in any of the following outcomes, was considered to be a serious adverse event: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect.

Secondary Outcome Measures

Response Ratio
The Response Ratio calculated by the following equation : Response Ratio = (T minus B) divided by (T plus B), where T is seizure frequency per 28 days (i.e., the number of seizures per 28 days) calculated from the total number of seizures for the 52-week treatment period, and B is seizure frequency per 28 days (i.e., the number of seizures per 28 days) calculated from the total number of seizures for the 6-week baseline period of the previous study A9451162 (NCT00603473).
Responder Rate
Responder Rate was defined as the percentage of subjects with a 50 percent or greater reduction in the seizure frequency per 28 days for the 52-week treatment period in comparison with the frequency per 28 days for the 6-week baseline period of the previous study A9451162 (NCT00603473).
Percent Change in Seizure Frequency
Percent change in seizure frequency (PCH) was calculated as follows: PCH = 100*(T minus B) divided by B, where T is seizure frequency per 28 days (i.e., the number of seizures per 28 days) calculated from the total number of seizures for the 52-week treatment period, and B is seizure frequency per 28 days (i.e., the number of seizures per 28 days) calculated from the total number of seizures for the 6-week baseline period of the previous study A9451162 (NCT00603473).

Full Information

First Posted
February 11, 2008
Last Updated
February 1, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00620555
Brief Title
A Phase III Open-Label Extension Study Of Gabapentin As Adjunctive Therapy In Japanese Pediatric Patients With Partial Seizures
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)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsies, Partial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
gabapentin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
gabapentin
Intervention Description
Orally administered gabapentin
Primary Outcome Measure Information:
Title
Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-Related)
Description
Any untoward medical occurrence in a participant who received study drug was considered an adverse event (AE), without regard to possibility of causal relationship. Treatment-emergent adverse events: those which occurred or worsened after baseline. Severe AEs: those which interferes significantly with participant's usual function. An AE resulting in any of the following outcomes, was considered to be a serious adverse event: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect.
Time Frame
up to 53 weeks
Secondary Outcome Measure Information:
Title
Response Ratio
Description
The Response Ratio calculated by the following equation : Response Ratio = (T minus B) divided by (T plus B), where T is seizure frequency per 28 days (i.e., the number of seizures per 28 days) calculated from the total number of seizures for the 52-week treatment period, and B is seizure frequency per 28 days (i.e., the number of seizures per 28 days) calculated from the total number of seizures for the 6-week baseline period of the previous study A9451162 (NCT00603473).
Time Frame
Up to 52 weeks
Title
Responder Rate
Description
Responder Rate was defined as the percentage of subjects with a 50 percent or greater reduction in the seizure frequency per 28 days for the 52-week treatment period in comparison with the frequency per 28 days for the 6-week baseline period of the previous study A9451162 (NCT00603473).
Time Frame
Up to 52 weeks
Title
Percent Change in Seizure Frequency
Description
Percent change in seizure frequency (PCH) was calculated as follows: PCH = 100*(T minus B) divided by B, where T is seizure frequency per 28 days (i.e., the number of seizures per 28 days) calculated from the total number of seizures for the 52-week treatment period, and B is seizure frequency per 28 days (i.e., the number of seizures per 28 days) calculated from the total number of seizures for the 6-week baseline period of the previous study A9451162 (NCT00603473).
Time Frame
Up to 52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Obu-shi,Morioka-machi
State/Province
Aichi
Country
Japan
Facility Name
Pfizer Investigational Site
City
Jonan-ku
State/Province
Fukuoka
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kobe
State/Province
Hyogo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Suma-Ku,Kobe
State/Province
Hyogo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kanazawa
State/Province
Ishikawa
Country
Japan
Facility Name
Pfizer Investigational Site
City
Zentsuuji
State/Province
Kagawa
Country
Japan
Facility Name
Pfizer Investigational Site
City
Yokohama
State/Province
Kanagawa Pref.
Country
Japan
Facility Name
Pfizer Investigational Site
City
Sendai-shi
State/Province
Miyagi-ken
Country
Japan
Facility Name
Pfizer Investigational Site
City
Showa-Ku
State/Province
Nagoya
Country
Japan
Facility Name
Pfizer Investigational Site
City
Niigata-shi
State/Province
Niigata
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kurashiki-City
State/Province
Okayama Pref.
Country
Japan
Facility Name
Pfizer Investigational Site
City
Okayama-shi
State/Province
Okayama
Country
Japan
Facility Name
Pfizer Investigational Site
City
Izumi-shi
State/Province
Osaka
Country
Japan
Facility Name
Pfizer Investigational Site
City
Miyakojima-ku
State/Province
Osaka
Country
Japan
Facility Name
Pfizer Investigational Site
City
Suita
State/Province
Osaka
Country
Japan
Facility Name
Pfizer Investigational Site
City
Shizuoka-shi
State/Province
Shizuoka
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kodaira
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Setagaya-ku
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Shinjuku-ku
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Hiroshima
Country
Japan
Facility Name
Pfizer Investigational Site
City
Saitama
Country
Japan
Facility Name
Pfizer Investigational Site
City
Yamagata
Country
Japan

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A9451165&StudyName=A%20Phase%20III%20Open-Label%20Extension%20Study%20Of%20Gabapentin%20As%20Adjunctive%20Therapy%20In%20Japanese%20Pediatric%20Patients%20With%20Partial%20Seizures
Description
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A Phase III Open-Label Extension Study Of Gabapentin As Adjunctive Therapy In Japanese Pediatric Patients With Partial Seizures

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