Assess Safety and Efficacy of Lacosamide in Patients With Partial Seizures - Full Text View

Sponsor:	UCB, Inc.
Information provided by:	UCB, Inc.
ClinicalTrials.gov Identifier:	NCT00515619

Purpose

Lacosamide (LCM) is an investigational drug that is being studied as a treatment in male and female patients with partial seizures in the indication Epilepsy.

The main purpose of this trial is to determine safety and efficacy of Lacosamide under long term therapy.

Condition	Intervention	Phase
Epilepsy	Drug: Lacosamide	Phase III

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	An International Open-label Extension Trial to Determine Safety and Efficacy of Long-term Oral Lacosamide (SPM 927) in Patients With Partial 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:

Safety of long-term exposure to lacosamide evaluated with the monitoring of adverse events (AEs), ECGs, vital signs, and clinical laboratory data. [ Time Frame: At periodic clinic visits throughout the trial ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Efficacy and maintenance of efficacy with long-term exposure to lacosamide is evaluated based on reduction in seizure frequency, 50 percent reduction in seizures, number and percentage of seizure-free days, and achievement of seizure-free status. [ Time Frame: At periodic clinic visits throughout the trial ] [ Designated as safety issue: No ]

Enrollment:	376
Study Start Date:	December 2004
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Lacosamide: Experimental Up to 800mg/day lacosamide (flexible dosing)	Drug: Lacosamide 50 mg tablets or 100 mg tablets; up to 800mg/day given as BID dosing throughout the trial

Eligibility

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

Criteria

Inclusion Criteria:

diagnosis of Epilepsy
completion of double blind trial

Exclusion Criteria:

taking other investigational drug than Lacosamide
meeting withdrawal criteria from double blind trial

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00515619

Show 57 Study Locations

Sponsors and Collaborators

UCB, Inc.

Investigators

Study Director:

UCB Clinical Trial Call Center

+1 877 822 9493

More Information

No publications provided

Responsible Party:	UCB ( Study Director )
Study ID Numbers:	SP774
Study First Received:	August 13, 2007
Last Updated:	November 17, 2009
ClinicalTrials.gov Identifier:	NCT00515619 History of Changes
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration; Croatia: Ministry of Health and Social Care; Czech Republic: State Institute for Drug Control; Finland: Finnish Medicines Agency; France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Hungary: National Institute of Pharmacy; Lithuania: State Medicine Control Agency - Ministry of Health; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Russia: Ministry of Health and Social Development of the Russian Federation; Spain: Spanish Agency of Medicines; Sweden: Medical Products Agency; United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:

Epilepsy
Nervous System Diseases
Central Nervous System Diseases
Brain Diseases

ClinicalTrials.gov processed this record on November 20, 2009