Clinical trial NCT00515619: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Epilepsy
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2007-08-14
Enrollment: 376
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Number of Subjects Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) During the Treatment Period (up to 5.5 Years)
timeFrame: During the Treatment Period (up to 5.5 years)
measure: Number of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event (TEAE) During the Treatment Period (up to 5.5 Years)
timeFrame: During the Treatment Period (up to 5.5 years)
measure: Number of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (up to 5.5 Years)
timeFrame: During the Treatment Period (up to 5.5 years)
Secondary outcomes:
measure: Median Percentage Change From Baseline in 28-day Seizure Frequency During the Treatment Period (up to 5.5 Years)
timeFrame: Baseline, Treatment Period (up to 5.5 years)
measure: Percentage of at Least 50% Responders During the Treatment Period (up to 5.5 Years)
timeFrame: Treatment Period (up to 5.5 years)
Other outcomes:
Locations:
city: Randwick
country: Australia
state: New South Wales
city: Maroochydore
country: Australia
state: Queensland
city: Woodville
country: Australia
state: South Australia
city: Clayton
country: Australia
state: Victoria
city: Parkville
country: Australia
state: Victoria
city: West Heidelberg
country: Australia
state: Victoria
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
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
Study officials:
affiliation: +1 877 822 9493
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
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.
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.