Trial to Assess the Long-Term Safety of Oral Lacosamide in Patients With Partial-Onset Seizures - Full Text View

Sponsored by:	UCB
Information provided by:	UCB
ClinicalTrials.gov Identifier:	NCT00655486

Purpose

The purpose of this trial is to allow eligible subjects from the parent trial to continue lacosamide and to obtain additional long-term safety data.

Condition	Intervention	Phase
Partial Epilepsies	Drug: lacosamide	Phase III

Genetics Home Reference related topics: autosomal dominant partial epilepsy with auditory features pyridoxal 5'-phosphate-dependent epilepsy pyridoxine-dependent epilepsy

MedlinePlus related topics: Epilepsy Seizures

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety Study
Official Title:	A Multicenter, Open-Label Extension Trial to Assess the Long-Term Safety and Tolerabiity of Lacosamide as Adjunctive Therapy in Subjects With Partial-Onset Seizures

Further study details as provided by UCB:

Primary Outcome Measures:

Adverse events reported spontaneously by the subject or observed by the investigator; withdrawals due to adverse events. [ Time Frame: During periodic clinical visits over approximately 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Changes in hematology, chemistry, urinalysis, ECGs, vital signs and body weight [ Time Frame: During periodic clinical visits over approximately 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	100
Study Start Date:	April 2008
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Subjects dose of lacosamide may be increased, or decreased, as needed to maintain a subject's effective and tolerable dose during the study.	Drug: lacosamide 50mg or 100mg tablets; 100mg/day up to 800mg/day given as BID dosing throughout the trial.

Detailed Description:

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 who were previously enrolled in the SP925 trial (intravenous lacosamide loading dose followed by approximately 1 week of oral lacosamide maintenance).

Eligibility

Ages Eligible for Study:	16 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Eligible subjects who participated in SP925 for treatment of partial-onset seizures

Exclusion Criteria:

Receiving any study drug or experimental device other than lacosamide. Meets withdrawal criteria for parent trial or experiencing ongoing serious adverse event.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00655486

Locations

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

Investigators

Study Director:

UCB Clinical Trial Call Center

+1 877 822 9493 (UCB)

More Information

Responsible Party:	UCB ( Study Director )
Study ID Numbers:	SP926
Study First Received:	March 26, 2008
Last Updated:	October 23, 2008
ClinicalTrials.gov Identifier:	NCT00655486
Health Authority:	United States: Food and Drug Administration

Keywords provided by UCB:

Adjunctive treatment in epilepsy
add-on treatment for epilepsy
partial seizures
AEDs

antiepileptic drugs
seizures
Vimpat

Study placed in the following topic categories:

Epilepsies, Partial
Epilepsy
Seizures
Central Nervous System Diseases
Brain Diseases

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009