The main purpose of this trial is to determine safety and efficacy of Lacosamide under long term therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
376
50 mg and 100 mg tablets up to 800 mg/day as twice day (BID) dosing throughout the trial
Number of Subjects Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) 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.
Time frame: During the Treatment Period (up to 5.5 years)
Number of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event (TEAE) 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.
Time frame: During the Treatment Period (up to 5.5 years)
Number of Subjects Reporting at Least 1 Serious Adverse Event (SAE) 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.
Time frame: During the Treatment Period (up to 5.5 years)
Median Percentage Change From Baseline in 28-day Seizure Frequency During the 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.
Time frame: Baseline, Treatment Period (up to 5.5 years)
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Unnamed facility
Randwick, New South Wales, Australia
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Maroochydore, Queensland, Australia
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Woodville, South Australia, Australia
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Clayton, Victoria, Australia
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Parkville, Victoria, Australia
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West Heidelberg, Victoria, Australia
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Adelaide, Australia
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Zagreb, Croatia
Unnamed facility
Brno, Czechia
Unnamed facility
Hradec Králové, Czechia
...and 44 more locations
Percentage of at Least 50% Responders During the 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
Time frame: Treatment Period (up to 5.5 years)