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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Pfizer

ClinicalTrials.gov Identifier:

NCT00620555

First received: February 11, 2008

Last updated: January 24, 2012

Last verified: November 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

February 11, 2008

Last Updated Date

January 24, 2012

Start Date ^ICMJE

May 2008

Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-Related) [ Time Frame: up to 53 weeks ] [ Designated as safety issue: Yes ]

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.

Original Primary Outcome Measures ^ICMJE

Safety (adverse events, serious adverse events, withdrawals due to adverse events, results of clinical laboratory tests) [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

Change History

Complete list of historical versions of study NCT00620555 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Response Ratio [ Time Frame: Up to 52 weeks ] [ Designated as safety issue: No ]
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 [ Time Frame: Up to 52 weeks ] [ Designated as safety issue: No ]
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 [ Time Frame: Up to 52 weeks ] [ Designated as safety issue: No ]
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).

Original Secondary Outcome Measures ^ICMJE

Response Ratio, Responder Rate, Percent change in seizure frequency [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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)

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Epilepsies, Partial

Intervention ^ICMJE

Drug: gabapentin

Orally administered gabapentin

Study Arm (s)

Experimental: gabapentin

Intervention: Drug: gabapentin

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2010

Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

3 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Japan

Administrative Information

NCT Number ^ICMJE

NCT00620555

Other Study ID Numbers ^ICMJE

A9451165

Has Data Monitoring Committee

Responsible Party

Pfizer

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

November 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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