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

• ClinicalTrials.gov Identifier: NCT00620555
• Recruitment Status: Completed
• First Posted: February 21, 2008
• Results First Posted: December 20, 2011
• Last Update Posted: February 3, 2021
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Information provided by (Responsible Party): Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )

Tracking Information

• First Submitted Date: February 11, 2008
• First Posted Date: February 21, 2008
• Results First Submitted Date: November 14, 2011
• Results First Posted Date: December 20, 2011
• Last Update Posted Date: February 3, 2021
• Study Start Date: May 2008
• Actual Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 24, 2012)

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 Measures (submitted: February 11, 2008): Safety (adverse events, serious adverse events, withdrawals due to adverse events, results of clinical laboratory tests) [ Time Frame: 52 weeks ]

Current Secondary Outcome Measures (submitted: January 24, 2012)

• 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 Measures (submitted: February 11, 2008): Response Ratio, Responder Rate, Percent change in seizure frequency [ Time Frame: 52 weeks ]
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Phase III Open-Label Extension Study Of Gabapentin As Adjunctive Therapy In Japanese Pediatric Patients With Partial Seizures
• 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 (NCT00603473)
• Brief Summary: Examine the safety and efficacy of gabapentin as adjunctive therapy in Japanese pediatric patients with partial seizures
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Epilepsies, Partial

Intervention

Drug: gabapentin

Orally administered gabapentin

Study Arms

Experimental: gabapentin

Intervention: Drug: gabapentin

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 12, 2011): 65
• Original Estimated Enrollment (submitted: February 11, 2008): 80
• Actual Study Completion Date: December 2010
• Actual Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 3 Years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Japan

Administrative Information

• NCT Number: NCT00620555
• Other Study ID Numbers: A9451165
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )
• Original Responsible Party: Director, Clinical Trials Disclosure Group, Pfizer, Inc.
• Current Study Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Original Study Sponsor: Pfizer
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: November 2011