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

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.92 enrolled

Overview

Examine the efficacy, safety and pharmacokinetics 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 YearsMax age: 15 Years

Medical Language ↔ Plain English

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

Locations (26)

Pfizer Investigational Site

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

Outcomes

Primary Outcomes

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.

Time frame: 12 weeks

Secondary Outcomes

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.

Time frame: 12 weeks

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.

Time frame: 12 weeks

Data from ClinicalTrials.gov

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