Trial to Assess Long-term Lacosamide (LCM) Monotherapy Use and Safety of LCM Monotherapy and Adjunctive Therapy for Partial-onset Seizures - Full Text View

Sponsor:	UCB, Inc.
Information provided by:	UCB, Inc.
ClinicalTrials.gov Identifier:	NCT00530855

Purpose

This open-label extension trial will assess the long-term use of lacosamide monotherapy and safety of lacosamide monotherapy and adjunctive therapy in subjects with partial-onset seizures who were previously enrolled in the conversion to monotherapy trial (SP902).

Condition	Intervention	Phase
Epilepsy	Drug: Lacosamide	Phase III

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Multicenter, Open-label Extension Trial to Assess the Long-term Use of Lacosamide Monotherapy and Safety of Lacosamide Monotherapy and Adjunctive Therapy in Subjects With Partial-onset Seizures

Resource links provided by NLM:

Genetics Home Reference related topics: pyridoxal 5'-phosphate-dependent epilepsy pyridoxine-dependent epilepsy

MedlinePlus related topics: Epilepsy Seizures

U.S. FDA Resources

Further study details as provided by UCB, Inc.:

Primary Outcome Measures:

To obtain information about the percentage of subjects who remain on lacosamide monotherapy, and the duration of lacosamide monotherapy treatment. [ Time Frame: 2 years after Visit 1 in SP904 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Obtain information about the long-term safety of lacosamide when used as monotherapy or adjunctive therapy by assessing adverse events [ Time Frame: 2 years after Visit 1 in SP904 ] [ Designated as safety issue: No ]
Subject withdrawal due to adverse events [ Time Frame: 2 years after Visit 1 in SP904 ] [ Designated as safety issue: No ]
Changes in hematology, blood chemistry, urinalysis parameters [ Time Frame: 2 years after Visit 1 in SP904 ] [ Designated as safety issue: No ]
Changes in physical or neurological examination findings [ Time Frame: 2 years after Visit 1 in SP904 ] [ Designated as safety issue: No ]
Changes in vital sign measurements (i.e., 12-lead ECG, blood pressure, pulse, weight). [ Time Frame: 2 years after Visit 1 in SP904 ] [ Designated as safety issue: No ]

Estimated Enrollment:	225
Study Start Date:	January 2008
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Lacosamide: Experimental lacosamide tablets for dosing 100 -800 mg/day	Drug: Lacosamide 50 mg and 100 mg lacosamide tablets taken for 50 -400 mg twice daily dosing for up to 2 years

Eligibility

Ages Eligible for Study:	16 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subject has entered the Maintenance Phase of the double-blind trial, SP902, (ie, has taken at least 1 dose of SP902 Maintenance Phase trial medication) and either completed SP902 or met an exit criterion in SP902; subject is allowed up to 2 concomitant AEDs.

Exclusion Criteria:

Subject meets the withdrawal criteria (excluding exit criteria) for the SP902 trial including, but not limited to, pregnancy, or noncompliance with trial procedures or medication.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00530855

Show 55 Study Locations

Sponsors and Collaborators

UCB, Inc.

Investigators

Study Director:

UCB Clinical Trial Call Center

+1 877 822 9493 (UCB)

More Information

No publications provided

Responsible Party:	UCB ( Study Director )
Study ID Numbers:	SP904
Study First Received:	September 14, 2007
Last Updated:	December 14, 2009
ClinicalTrials.gov Identifier:	NCT00530855 History of Changes
Health Authority:	United States: Food and Drug Administration; Portugal: National Pharmacy and Medicines Institute; Switzerland: Swissmedic; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Spain: Spanish Agency of Medicines; Denmark: Danish Medicines Agency; Austria: Agency for Health and Food Safety; Ireland: Irish Medicines Board; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Netherlands: Medicines Evaluation Board (MEB); Canada: Health Canada; Australia: Department of Health and Ageing Therapeutic Goods Administration; Italy: Ministry of Health; France: Afssaps - French Health Products Safety Agency

Keywords provided by UCB, Inc.:

Epilepsy
partial-onset seizures
lacosamide
monotherapy
Vimpat

Additional relevant MeSH terms:

Epilepsy
Nervous System Diseases
Central Nervous System Diseases
Brain Diseases

ClinicalTrials.gov processed this record on February 08, 2010