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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00603473
First received: January 16, 2008
Last updated: January 24, 2011
Last verified: January 2011

January 16, 2008
January 24, 2011
January 2008
December 2009   (final data collection date for primary outcome measure)
Response Ratio of Gabapentin in Japanese Pediatric Patients With Partial Seizures [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
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.
To confirm Response Ratio of Gabapentin in Japanese pediatric patients with partial seizures [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00603473 on ClinicalTrials.gov Archive Site
  • Responder Rate [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
  • Responder Rate, Percent change in seizure frequency, Pharmacokinetics [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
A Phase III Open-Label Study Of Gabapentin As Adjunctive Therapy In Japanese Pediatric Patients With Partial Seizures
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

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

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Epilepsies, Partial
Drug: gabapentin
Orally administered gabapentin
Experimental: gabapentin
Intervention: Drug: gabapentin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
92
December 2009
December 2009   (final data collection date for primary outcome measure)

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
Both
3 Years to 15 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00603473
A9451162
No
Director, Clinical Trials Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP