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

Phase 3CompletedNCT00620555

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.65 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Epilepsies, Partial

Interventions

gabapentinDRUG

Orally administered gabapentin

Eligibility

Sex: ALLMin age: 3 Years

Medical Language ↔ Plain English

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

Locations (22)

Pfizer Investigational Site

Obu-shi,Morioka-machi, Aichi-ken, Japan

Pfizer Investigational Site

Jonan-ku, Fukuoka, Japan

Outcomes

Primary Outcomes

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.

Time frame: up to 53 weeks

Secondary Outcomes

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).

Time frame: Up to 52 weeks

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).

Time frame: Up to 52 weeks

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).

Data from ClinicalTrials.gov

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