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

Viatris

Status and phase: Completed; Phase 3

Conditions: Epilepsies, Partial

Treatments: Drug: gabapentin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00620555

A9451165

Details and patient eligibility

About

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

Enrollment: 65 patients

Sex: All

Ages: 3+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Completion of study A9451162 (NCT00603473)

Exclusion criteria

• Seizures related to drugs or acute medical illness
• History of any serious medical or psychiatric disorder

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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65 participants in 1 patient group

gabapentin

Experimental group

Treatment:

Drug: gabapentin