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

Phase 3

Completed

• Conditions: Epilepsies, Partial
• Interventions: Drug: gabapentin

• Registration Number: NCT00620555
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-02-11
• Study First Submitted QC: 2008-02-11
• Study First Posted: 2008-02-21
• Study Start: 2008-05
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2011-11
• Results First Submitted: 2011-11-14
• Results First Submitted QC: 2011-11-14
• Results First Posted: 2011-12-20
• Last Update Submitted: 2021-02-01
• Last Update Posted: 2021-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

• Completion of study A9451162 (NCT00603473)

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
gabapentin	gabapentin	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-Related)	up to 53 weeks	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

Name	Time	Method
Response Ratio	Up to 52 weeks	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	Up to 52 weeks	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	Up to 52 weeks	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).

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇯🇵 Yamagata, Japan