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

• ClinicalTrials.gov Identifier: NCT00655486
• Recruitment Status: Completed
• First Posted: April 10, 2008
• Results First Posted: July 15, 2011
• Last Update Posted: July 17, 2018
• Sponsor: UCB BIOSCIENCES, Inc.
• Information provided by (Responsible Party): UCB Pharma ( UCB BIOSCIENCES, Inc. )

Study Description

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

Condition or disease	Intervention/treatment	Phase
Partial Epilepsies; Partial Onset Seizures	Drug: lacosamide	Phase 3

Expanded Access : An investigational treatment associated with this study is no longer available outside the clinical trial.   More info ...

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 97 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official 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
• Study Start Date: April 2008
• Actual Primary Completion Date: June 2010
• Actual Study Completion Date: June 2010

Arms and Interventions

Arm	Intervention/treatment
Experimental: Lacosamide; Lacosamide 100 to 800 mg/day, flexible dosing, administered twice daily throughout the duration of the study (up to 2 years)	Drug: lacosamide; 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 Name: Vimpat

Outcome Measures

Primary Outcome Measures :

1. 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).
2. 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).

Eligibility Criteria

• Ages Eligible for Study: 16 Years to 60 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Arizona

Phoenix, Arizona, United States

United States, Maryland

Baltimore, Maryland, United States

United States, Missouri

Chesterfield, Missouri, United States

United States, Ohio

Columbus, Ohio, United States

United States, Pennsylvania

Philadelphia, Pennsylvania, United States

United States, Texas

Dallas, Texas, United States

United States, Virginia

Charlottesville, Virginia, United States

Sponsors and Collaborators

UCB BIOSCIENCES, Inc.

Investigators

• Study Director: UCB Clinical Trial Call Center; +1 877 822 9493 (UCB)

More Information

Additional Information:

FDA Safety Alerts and Recalls 

• Responsible Party: UCB BIOSCIENCES, Inc.
• ClinicalTrials.gov Identifier: NCT00655486
• Other Study ID Numbers: SP0926; 2014-004384-21 ( EudraCT Number )
• First Posted: April 10, 2008
• Results First Posted: July 15, 2011
• Last Update Posted: July 17, 2018
• Last Verified: July 2017

Keywords provided by UCB Pharma ( UCB BIOSCIENCES, Inc. ):

Epilepsy; seizures; antiepileptic; Lacosamide; Vimpat; safety; adjunctive

Additional relevant MeSH terms:

Epilepsy; Seizures; Epilepsies, Partial; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Lacosamide; Anticonvulsants; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action