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

Purpose

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 3

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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:

MedlinePlus related topics: Epilepsy Seizures

Drug Information available for: Lacosamide

U.S. FDA Resources

Further study details as provided by UCB, Inc.:

Primary Outcome Measures:

Number of Subjects Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) During the Treatment Period (up to 5.5 Years) [ Time Frame: During the Treatment Period (up to 5.5 years) ] [ Designated as safety issue: No ]
Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
Number of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event (TEAE) During the Treatment Period (up to 5.5 Years) [ Time Frame: During the Treatment Period (up to 5.5 years) ] [ Designated as safety issue: No ]
Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
Number of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (up to 5.5 Years) [ Time Frame: During the Treatment Period (up to 5.5 years) ] [ Designated as safety issue: No ]
A serious adverse event is any untoward medical occurrences in a subject administered study treatment, whether or not the event is related to treatment, with at least one of the follow outcomes: death, life-threatening, initial inpatient hospitalization or prolongation of hospitalization, significant or persistent disability/incapacity, congenital anomaly/birth defect, or an important medical event that may jeopardize the subject and require a medical/surgical intervention.

Secondary Outcome Measures:

Median Percentage Change From Baseline in 28-day Seizure Frequency During the Treatment Period (up to 5.5 Years) [ Time Frame: Baseline, Treatment Period (up to 5.5 years) ] [ Designated as safety issue: No ]
Median percentage change is the median value with respect to the percent change from Baseline across the population of subjects. Percentage change is calculated as 100 times the difference of the seizure frequency for the treatment period and the Baseline seizure frequency divided by the baseline seizure frequency.

Negative changes from Baseline indicate an improvement (i.e., a reduction) in 28-day seizure frequency.
Percentage of at Least 50% Responders During the Treatment Period (up to 5.5 Years) [ Time Frame: Treatment Period (up to 5.5 years) ] [ Designated as safety issue: No ]
At least 50 percent response is based on the percentage reduction in 28-day seizure frequency during the Treatment Period of the open-label extension relative to the Baseline Phase of the prior study. This endpoint reflects the percentage of subjects with at least 50% reduction (ie, at least 50% change) in 28-day partial onset seizure frequency

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

Arms	Assigned Interventions
Experimental: Lacosamide 50 mg and 100 mg tablets up to 800 mg/day as twice day (BID) dosing	Drug: Lacosamide 50 mg and 100 mg tablets up to 800 mg/day as twice day (BID) dosing throughout the trial Other Names: SPM 927 LCM

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

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

Sponsors and Collaborators

UCB, Inc.

Investigators

Study Director:

UCB Clinical Trial Call Center

+1 877 822 9493

More Information

Additional Information:

Product Information This link exits the ClinicalTrials.gov site

FDA Safety Alerts and Recalls This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	UCB, Inc.
ClinicalTrials.gov Identifier:	NCT00515619 History of Changes
Other Study ID Numbers:	SP774
Study First Received:	August 13, 2007
Results First Received:	August 5, 2011
Last Updated:	September 8, 2011
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 - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) 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 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
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 19, 2013