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

Phase 3

Completed

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

• Registration Number: NCT00603473
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-01-16
• Study First Submitted QC: 2008-01-16
• Study First Posted: 2008-01-29
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Results First Submitted: 2010-12-06
• Status Verified: 2011-01
• Results First Submitted QC: 2011-01-24
• Results First Posted: 2011-02-21
• Last Update Submitted: 2021-02-01
• Last Update Posted: 2021-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
gabapentin	gabapentin	-

Primary Outcome Measures

Name	Time	Method
Response Ratio of Gabapentin in Japanese Pediatric Patients With Partial Seizures	12 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Responder Rate	12 weeks	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)	12 weeks	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.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇯🇵 Yamanashi, Japan