Assess Safety and Efficacy of Lacosamide in Patients With Partial Seizures

Phase 3

Completed

• Conditions: Epilepsy
• Interventions: Drug: Lacosamide

• Registration Number: NCT00515619
• Lead Sponsor: UCB Pharma

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2004-12
• Study First Submitted: 2007-08-13
• Study First Submitted QC: 2007-08-13
• Study First Posted: 2007-08-14
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Results First Submitted: 2011-08-05
• Results First Submitted QC: 2011-08-05
• Results First Posted: 2011-09-09
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-28
• Last Update Posted: 2017-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 376

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lacosamide	Lacosamide	50 mg and 100 mg tablets up to 800 mg/day as twice day (BID) dosing

Primary Outcome Measures

Name	Time	Method
Number of Subjects Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) During the Treatment Period (up to 5.5 Years)	During the Treatment Period (up to 5.5 years)	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)	During the Treatment Period (up to 5.5 years)	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)	During the Treatment Period (up to 5.5 years)	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

Name	Time	Method
Median Percentage Change From Baseline in 28-day Seizure Frequency During the Treatment Period (up to 5.5 Years)	Baseline, Treatment Period (up to 5.5 years)	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)	Treatment Period (up to 5.5 years)	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