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

This study has been completed.

Sponsor:

Information provided by:

Pfizer

ClinicalTrials.gov Identifier:

NCT00603473

First received: January 16, 2008

Last updated: January 24, 2011

Last verified: January 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

January 16, 2008

Last Updated Date

January 24, 2011

Start Date ^ICMJE

January 2008

Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Response Ratio of Gabapentin in Japanese Pediatric Patients With Partial Seizures [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

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.

Original Primary Outcome Measures ^ICMJE

To confirm Response Ratio of Gabapentin in Japanese pediatric patients with partial seizures [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT00603473 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Responder Rate [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
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) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
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.

Original Secondary Outcome Measures ^ICMJE

Responder Rate, Percent change in seizure frequency, Pharmacokinetics [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Safety [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

Examine the efficacy, safety and pharmacokinetics 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: 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 2009

Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

3 Years to 15 Years

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

NCT00603473

Other Study ID Numbers ^ICMJE

A9451162

Has Data Monitoring Committee

Responsible Party

Director, Clinical Trials Disclosure Group, Pfizer, Inc.

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

January 2011

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

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