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

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