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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A 52 Weeks, Open-Label, Multicenter Study Evaluating The Efficacy And Safety Of Gabapentin As Adjunctive Therapy In Pediatric Patients Who Have Completed The 12 Weeks Treatment In Study A9451162 (NCT0

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

Detailed Summary:
Sponsor: Pfizer

Current Primary Outcome: Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-Related) [ Time Frame: 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.


Original Primary Outcome: Safety (adverse events, serious adverse events, withdrawals due to adverse events, results of clinical laboratory tests) [ Time Frame: 52 weeks ]

Current Secondary Outcome:

  • Response Ratio [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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).


Original Secondary Outcome: Response Ratio, Responder Rate, Percent change in seizure frequency [ Time Frame: 52 weeks ]

Information By: Pfizer

Dates:
Date Received: February 11, 2008
Date Started: May 2008
Date Completion:
Last Updated: January 24, 2012
Last Verified: November 2011