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

NCT00603473

Last updated date
Study Location
Pfizer Investigational Site
Obu-shi,Morioka-machi, Aichi, , Japan
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Partial Epilepsies
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
3-15 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Phase III Open-Label Study Of Gabapentin As Adjunctive Therapy In Japanese Pediatric Patients With Partial Seizures
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Epilepsies, Partial
Intervention  ICMJE Drug: gabapentin
Orally administered gabapentin
Study Arms  ICMJE Experimental: gabapentin
Intervention: Drug: gabapentin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 26, 2010)
92
Original Estimated Enrollment  ICMJE
 (submitted: January 16, 2008)
95
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 3 Years to 15 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00603473
Other Study ID Numbers  ICMJE A9451162
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trials Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date January 2011

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