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

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Obu-shi,Morioka-machi, Aichi, Japan
Contact
1-800-718-1021
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

NCT00603473
Pfizer
Completed
A Phase III Open-Label Study Of Gabapentin As Adjunctive Therapy In Japanese Pediatric Patients With Partial Seizures

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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
Intervention Model: Single Group Assignment
Masking: None (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
Sexes Eligible for Study: All
3 Years to 15 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT00603473
A9451162
No
Not Provided
Not Provided
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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]



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