Study to Assess the Long-term Safety of Oral Lacosamide in Subjects With Partial-onset Seizures

UCB BIOSCIENCES, Inc.97 enrolled

Overview

The purpose of this study is to allow eligible subjects from the parent study, SP925 \[NCT00655551\] to continue lacosamide and to obtain additional long-term safety data

A multicenter, open-label extension study to assess the long-term safety and tolerability of lacosamide as adjunctive therapy in subjects with partial-onset seizures who were previously enrolled in the SP925 study \[NCT00655551\] (intravenous lacosamide loading dose followed by approximately 1 week of oral lacosamide maintenance).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Partial Epilepsies Partial Onset Seizures

Interventions

lacosamideDRUG

Subjects' dose of lacosamide may be increased or decreased as needed to maintain a subject's effective and tolerable dose during the study. Tablets are 50 mg or 100 mg each; Dose is 100 mg/day up to 800 mg/day administered twice daily throughout the study (up to 2 years).

Eligibility

Sex: ALLMin age: 16 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Eligible subjects who participated in SP925 \[NCT00655551\] for treatment of partial-onset seizures Exclusion Criteria: * Receiving any study drug or experimental device other than lacosamide * Meets withdrawal criteria for parent study SP925 \[NCT00655551\] * Experiencing ongoing serious adverse event

Locations (7)

Unnamed facility

Phoenix, Arizona, United States

Unnamed facility

Baltimore, Maryland, United States

Unnamed facility

Chesterfield, Missouri, United States

Unnamed facility

Columbus, Ohio, United States

Outcomes

Primary Outcomes

Number of Subjects With at Least One Adverse Event During This Open-label Extension Study (Maximum Study Duration 2 Years)

An Adverse Event (AE) is any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any period of a clinical trial including Pre-treatment, Run-In, Wash-Out, or Follow-Up Periods. An AE is defined as being independent of assumption of any causality (eg, to study or concomitant medication, primary or concomitant disease, or study design).

Time frame: 2 years

Number of Subjects Who Withdrew From the Study Due to an Adverse Event (Maximum Study Duration 2 Years)

Time frame: 2 years

Data from ClinicalTrials.gov

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