Assess Safety and Efficacy of Lacosamide in Patients With Partial Seizures
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|ClinicalTrials.gov Identifier: NCT00515619|
Recruitment Status : Completed
First Posted : August 14, 2007
Results First Posted : September 9, 2011
Last Update Posted : August 28, 2017
|Condition or disease||Intervention/treatment||Phase|
|Epilepsy||Drug: Lacosamide||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||376 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||December 2004|
|Actual Primary Completion Date :||August 2010|
|Actual Study Completion Date :||August 2010|
50 mg and 100 mg tablets up to 800 mg/day as twice day (BID) dosing
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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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.
- 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) ]
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) ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00515619
Hide Study Locations
|Australia, New South Wales|
|Randwick, New South Wales, Australia|
|Maroochydore, Queensland, Australia|
|Australia, South Australia|
|Woodville, South Australia, Australia|
|Clayton, Victoria, Australia|
|Parkville, Victoria, Australia|
|West Heidelberg, Victoria, Australia|
|Hradec Kralove, Czechia|
|Marburg, Germany, 35039|
|Moscow, Russian Federation|
|St. Petersburg, Russian Federation|
|Cardiff, United Kingdom|
|Dundee, United Kingdom|
|Glasgow, United Kingdom|
|London, United Kingdom|
|Salford, United Kingdom|
|Swansea, United Kingdom|
|Study Director:||UCB Clinical Trial Call Center||+1 877 822 9493|