Back to resultsAssess Safety and Efficacy of Lacosamide in Patients With Partial Seizures
Primary Purpose
Epilepsy
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Lacosamide
Sponsored by
About this trial
This is an interventional treatment trial for Epilepsy
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Lacosamide
Arm Description
50 mg and 100 mg tablets up to 800 mg/day as twice day (BID) dosing
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
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.
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00515619
Brief Title
Assess Safety and Efficacy of Lacosamide in Patients With Partial Seizures
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 Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Pharma
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The main purpose of this trial is to determine safety and efficacy of Lacosamide under long term therapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
376 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lacosamide
Arm Type
Experimental
Arm Description
50 mg and 100 mg tablets up to 800 mg/day as twice day (BID) dosing
Intervention Type
Drug
Intervention Name(s)
Lacosamide
Other Intervention Name(s)
SPM 927, LCM
Intervention Description
50 mg and 100 mg tablets up to 800 mg/day as twice day (BID) dosing throughout the trial
Primary Outcome Measure Information:
Title
Number of Subjects Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) During the Treatment Period (up to 5.5 Years)
Description
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)
Title
Number of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event (TEAE) During the Treatment Period (up to 5.5 Years)
Description
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)
Title
Number of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (up to 5.5 Years)
Description
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)
Secondary Outcome Measure Information:
Title
Median Percentage Change From Baseline in 28-day Seizure Frequency During the Treatment Period (up to 5.5 Years)
Description
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)
Title
Percentage of at Least 50% Responders During the Treatment Period (up to 5.5 Years)
Description
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Clinical Trial Call Center
Organizational Affiliation
+1 877 822 9493
Official's Role
Study Director
Facility Information:
City
Randwick
State/Province
New South Wales
Country
Australia
City
Maroochydore
State/Province
Queensland
Country
Australia
City
Woodville
State/Province
South Australia
Country
Australia
City
Clayton
State/Province
Victoria
Country
Australia
City
Parkville
State/Province
Victoria
Country
Australia
City
West Heidelberg
State/Province
Victoria
Country
Australia
City
Adelaide
Country
Australia
City
Zagreb
Country
Croatia
City
Brno
Country
Czechia
City
Hradec Kralove
Country
Czechia
City
Olomouc
Country
Czechia
City
Ostrava-Trebovice
Country
Czechia
City
Plzen
Country
Czechia
City
Prague
Country
Czechia
City
Helsinki
Country
Finland
City
Kuopio
Country
Finland
City
Oulu
Country
Finland
City
Tampere
Country
Finland
City
Lille
Country
France
City
Lyon
Country
France
City
Montpellier
Country
France
City
Paris
Country
France
City
Toulouse
Country
France
City
Berlin
Country
Germany
City
Erlangen
Country
Germany
City
Göttingen
Country
Germany
City
Marburg
ZIP/Postal Code
35039
Country
Germany
City
München
Country
Germany
City
Ulm
Country
Germany
City
Budapest
Country
Hungary
City
Pécs
Country
Hungary
City
Szeged
Country
Hungary
City
Szombathely
Country
Hungary
City
Kaunas
Country
Lithuania
City
Vilnius
Country
Lithuania
City
Bialystok
Country
Poland
City
Gdansk
Country
Poland
City
Krakow
Country
Poland
City
Warsaw
Country
Poland
City
Moscow
Country
Russian Federation
City
St. Petersburg
Country
Russian Federation
City
Girona
Country
Spain
City
Granada
Country
Spain
City
Madrid
Country
Spain
City
Zaragoza
Country
Spain
City
Gothenburg
Country
Sweden
City
Linköping
Country
Sweden
City
Stockholm
Country
Sweden
City
Cardiff
Country
United Kingdom
City
Dundee
Country
United Kingdom
City
Glasgow
Country
United Kingdom
City
London
Country
United Kingdom
City
Salford
Country
United Kingdom
City
Swansea
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
24275520
Citation
Borghs S, de la Loge C, Brabant Y, Cramer J. Sensitivity testing of the Seizure Severity Questionnaire (SSQ). Epilepsy Behav. 2014 Feb;31:281-5. doi: 10.1016/j.yebeh.2013.10.010. Epub 2013 Nov 22.
Results Reference
result
PubMed Identifier
26133811
Citation
Rosenow F, Kelemen A, Ben-Menachem E, McShea C, Isojarvi J, Doty P; SP774 study investigators. Long-term adjunctive lacosamide treatment in patients with partial-onset seizures. Acta Neurol Scand. 2016 Feb;133(2):136-144. doi: 10.1111/ane.12451. Epub 2015 Jul 2.
Results Reference
derived
Links:
URL
http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls
Learn more about this trial
Assess Safety and Efficacy of Lacosamide in Patients With Partial Seizures
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