Assess Safety and Efficacy of Lacosamide in Patients With Partial Seizures

UCB

Status and phase: Completed; Phase 3

Conditions: Epilepsy

Treatments: Drug: Lacosamide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00515619

SP0774

2004-000152-16 (EudraCT Number)

Details and patient eligibility

About

The main purpose of this trial is to determine safety and efficacy of Lacosamide under long term therapy.

Enrollment: 376 patients

Sex: All

Ages: 16 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• diagnosis of Epilepsy
• completion of double blind trial

Exclusion criteria

• taking other investigational drug than Lacosamide
• meeting withdrawal criteria from double blind trial

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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376 participants in 1 patient group

Lacosamide

Experimental group

Description:

50 mg and 100 mg tablets up to 800 mg/day as twice day (BID) dosing

Treatment:

Drug: Lacosamide