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

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

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Key information

Conditions

Partial Epilepsies Brain Diseases Central Nervous System Diseases Epilepsies, Partial Epilepsy Nervous System Diseases Neurologic Manifestations Partial Onset Seizures Pathological Conditions, Signs and Symptoms Seizures Signs and Symptoms

Age range

16 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Phoenix, Arizona, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lacosamide

Drug

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).

Other names: Vimpat

Primary outcomes

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

Time frame: 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)

Time frame: 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).

Sponsors and collaborators

Lead sponsor

UCB BIOSCIENCES, Inc.

Industry

Registry information

Official study title

A Multicenter, Open-label Extension Trial to Assess the Long-term Safety and Tolerability of Lacosamide as Adjunctive Therapy in Subjects With Partial-onset Seizures

Important dates

Study start: 2008
Primary completion: 2010
Study completion: 2010
First posted: Apr 10, 2008
Registry last updated: Jul 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed