Back to resultsA Phase III Open-Label 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
About this trial
This is an interventional treatment trial for Epilepsies, Partial
Eligibility Criteria
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
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
- 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
Response Ratio of Gabapentin in Japanese Pediatric Patients With Partial Seizures
The Response Ratio calculated by the following equation was assessed as the primary endpoint: R Ratio = (T-B) / (T+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 12-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.
Secondary Outcome Measures
Responder Rate
Responder Rate was defined as the percentage of subjects with a 50% or greater reduction in the seizure frequency per 28 days for the 12-week treatment period in comparison with the frequency per 28 days for the 6-week baseline period.
Percent Change in Seizure Frequency (PCH)
PCH calculated by the following equation was assessed as secondary endpoint: PCH = 100 (T-B) / 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 12-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.
Full Information
NCT ID
NCT00603473
First Posted
January 16, 2008
Last Updated
February 1, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00603473
Brief Title
A Phase III Open-Label Study Of Gabapentin As Adjunctive Therapy In Japanese Pediatric Patients With Partial Seizures
Official Title
An Open-Label, Multicenter Study Evaluating, The Efficacy, Safety And Pharmacokinetics Of Gabapentin As Adjunctive Therapy In Pediatric Patients With Partial Seizures When Other Antiepileptics Do Not Provide Satisfactory Effects
Study Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (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 efficacy, safety and pharmacokinetics 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
92 (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
Response Ratio of Gabapentin in Japanese Pediatric Patients With Partial Seizures
Description
The Response Ratio calculated by the following equation was assessed as the primary endpoint: R Ratio = (T-B) / (T+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 12-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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Responder Rate
Description
Responder Rate was defined as the percentage of subjects with a 50% or greater reduction in the seizure frequency per 28 days for the 12-week treatment period in comparison with the frequency per 28 days for the 6-week baseline period.
Time Frame
12 weeks
Title
Percent Change in Seizure Frequency (PCH)
Description
PCH calculated by the following equation was assessed as secondary endpoint: PCH = 100 (T-B) / 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 12-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.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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
Sapporo
State/Province
Hokkaido
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
Higashimatsuyama
State/Province
Saitama
Country
Japan
Facility Name
Pfizer Investigational Site
City
Shizuoka-shi
State/Province
Shizuoka
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kiyose-shi
State/Province
Tokyo
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
Facility Name
Pfizer Investigational Site
City
Yamanashi
Country
Japan
12. IPD Sharing Statement
Links:
URL
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
Description
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A Phase III Open-Label Study Of Gabapentin As Adjunctive Therapy In Japanese Pediatric Patients With Partial Seizures
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