Lamotrigine Extended-Release In Elderly Patients With Epilepsy

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Epilepsy

Treatments: Drug: Lamotrigine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00516139

LEP105972

Details and patient eligibility

About

This study is being conducted to determine the safety and tolerability of lamotrigine (LTG) in elderly patients with epilepsy. This study will be carried out using an extended-release formulation of lamotrigine (LTG-XR) that will allow once-a-day dosing.

Enrollment: 122 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Confident diagnosis of epilepsy
• Currently treated with one or two antiepileptic medications
• Able to complete a seizure diary

Exclusion criteria

• History of hypersensitivity to lamotrigine
• Progressive diseases that would interfere with the study objectives

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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122 participants in 1 patient group

Lamotrigine

Experimental group

Description:

Open-label lamotrigine

Treatment:

Drug: Lamotrigine