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

Phase 3

Completed

• Conditions: Partial Epilepsies; Partial Onset Seizures
• Interventions: Drug: lacosamide

• Registration Number: NCT00655486
• Lead Sponsor: UCB BIOSCIENCES, Inc.

Brief Summary

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

Detailed Description

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 Timeline

• Study First Submitted: 2008-03-26
• Study Start: 2008-04
• Study First Submitted QC: 2008-04-04
• Study First Posted: 2008-04-10
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Results First Submitted: 2011-06-15
• Results First Submitted QC: 2011-06-15
• Results First Posted: 2011-07-15
• Status Verified: 2017-07
• Last Update Submitted: 2018-06-20
• Last Update Posted: 2018-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 97

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lacosamide	lacosamide	Lacosamide 100 to 800 mg/day, flexible dosing, administered twice daily throughout the duration of the study (up to 2 years)

Primary Outcome Measures

Name	Time	Method
Number of Subjects With at Least One Adverse Event During This Open-label Extension Study (Maximum Study Duration 2 Years)	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).
Number of Subjects Who Withdrew From the Study Due to an Adverse Event (Maximum Study Duration 2 Years)	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).