Assess Safety and Efficacy of Lacosamide in Patients With Partial Seizures
NCT ID: NCT00515619
Last Updated: 2017-08-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
376 participants
INTERVENTIONAL
2004-12-31
2010-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Lacosamide
50 mg and 100 mg tablets up to 800 mg/day as twice day (BID) dosing
Lacosamide
50 mg and 100 mg tablets up to 800 mg/day as twice day (BID) dosing throughout the trial
Interventions
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Lacosamide
50 mg and 100 mg tablets up to 800 mg/day as twice day (BID) dosing throughout the trial
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* completion of double blind trial
Exclusion Criteria
* meeting withdrawal criteria from double blind trial
16 Years
70 Years
ALL
No
Sponsors
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UCB Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Clinical Trial Call Center
Role: STUDY_DIRECTOR
+1 877 822 9493
Locations
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Randwick, New South Wales, Australia
Maroochydore, Queensland, Australia
Woodville, South Australia, Australia
Clayton, Victoria, Australia
Parkville, Victoria, Australia
West Heidelberg, Victoria, Australia
Adelaide, , Australia
Zagreb, , Croatia
Brno, , Czechia
Hradec Králové, , Czechia
Olomouc, , Czechia
Ostrava-Trebovice, , Czechia
Pilsen, , Czechia
Prague, , Czechia
Helsinki, , Finland
Kuopio, , Finland
Oulu, , Finland
Tampere, , Finland
Lille, , France
Lyon, , France
Montpellier, , France
Paris, , France
Toulouse, , France
Berlin, , Germany
Erlangen, , Germany
Göttingen, , Germany
Marburg, , Germany
München, , Germany
Ulm, , Germany
Budapest, , Hungary
Pécs, , Hungary
Szeged, , Hungary
Szombathely, , Hungary
Kaunas, , Lithuania
Vilnius, , Lithuania
Bialystok, , Poland
Gdansk, , Poland
Krakow, , Poland
Warsaw, , Poland
Moscow, , Russia
Saint Petersburg, , Russia
Girona, , Spain
Granada, , Spain
Madrid, , Spain
Zaragoza, , Spain
Gothenburg, , Sweden
Linköping, , Sweden
Stockholm, , Sweden
Cardiff, , United Kingdom
Dundee, , United Kingdom
Glasgow, , United Kingdom
London, , United Kingdom
Salford, , United Kingdom
Swansea, , United Kingdom
Countries
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References
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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.
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.
Related Links
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FDA Safety Alerts and Recalls
Other Identifiers
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2004-000152-16
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
SP0774
Identifier Type: -
Identifier Source: org_study_id
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