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

• ClinicalTrials.gov Identifier: NCT00603473
• Recruitment Status: Completed
• First Posted: January 29, 2008
• Results First Posted: February 21, 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: January 16, 2008
• First Posted Date: January 29, 2008
• Results First Submitted Date: December 6, 2010
• Results First Posted Date: February 21, 2011
• Last Update Posted Date: February 3, 2021
• Study Start Date: January 2008
• Actual Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 24, 2011)

Response Ratio of Gabapentin in Japanese Pediatric Patients With Partial Seizures [ Time Frame: 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.

• Original Primary Outcome Measures (submitted: January 16, 2008): To confirm Response Ratio of Gabapentin in Japanese pediatric patients with partial seizures [ Time Frame: 12 weeks ]

Current Secondary Outcome Measures (submitted: January 24, 2011)

• Responder Rate [ Time Frame: 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) [ Time Frame: 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.

Original Secondary Outcome Measures (submitted: January 16, 2008)

• Responder Rate, Percent change in seizure frequency, Pharmacokinetics [ Time Frame: 12 weeks ]
• Safety [ Time Frame: 12 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 Study Of Gabapentin As Adjunctive Therapy In Japanese Pediatric Patients With Partial Seizures
• Official Title: An Open-Label, Multicenter Study Evaluating, The Efficacy, Safety And Pharmacokinetics Of Gabapentin As Adjunctive Therapy In Pediatric Patients With Partial Seizures When Other Antiepileptics Do Not Provide Satisfactory Effects
• Brief Summary: Examine the efficacy, safety and pharmacokinetics 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 26, 2010): 92
• Original Estimated Enrollment (submitted: January 16, 2008): 95
• Actual Study Completion Date: December 2009
• Actual Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 3 Years to 15 Years (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Japan

Administrative Information

• NCT Number: NCT00603473
• Other Study ID Numbers: A9451162
• 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: January 2011