A Phase III Open-Label 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

NCT00603473

A9451162

Details and patient eligibility

About

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

Enrollment: 92 patients

Sex: All

Ages: 3 to 15 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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92 participants in 1 patient group

gabapentin

Experimental group

Treatment:

Drug: gabapentin