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

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer; Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Treatments: Gabapentin; gamma-Aminobutyric Acid

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