Assess Safety and Efficacy of Lacosamide in Patients With Partial Seizures
An International Open-label Extension Trial to Determine Safety and Efficacy of Long-term Oral Lacosamide (SPM 927) in Patients With Partial Seizures
2 other identifiers
interventional
376
13 countries
54
Brief Summary
The main purpose of this trial is to determine safety and efficacy of Lacosamide under long term therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Dec 2004
Longer than P75 for phase_3
54 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2004
CompletedFirst Submitted
Initial submission to the registry
August 13, 2007
CompletedFirst Posted
Study publicly available on registry
August 14, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2010
CompletedResults Posted
Study results publicly available
September 9, 2011
CompletedAugust 28, 2017
July 1, 2017
5.7 years
August 13, 2007
August 5, 2011
July 28, 2017
Conditions
Outcome Measures
Primary Outcomes (3)
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.
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.
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.
During the Treatment Period (up to 5.5 years)
Secondary Outcomes (2)
Median Percentage Change From Baseline in 28-day Seizure Frequency During the Treatment Period (up to 5.5 Years)
Baseline, Treatment Period (up to 5.5 years)
Percentage of at Least 50% Responders During the Treatment Period (up to 5.5 Years)
Treatment Period (up to 5.5 years)
Study Arms (1)
Lacosamide
EXPERIMENTAL50 mg and 100 mg tablets up to 800 mg/day as twice day (BID) dosing
Interventions
50 mg and 100 mg tablets up to 800 mg/day as twice day (BID) dosing throughout the trial
Eligibility Criteria
You may qualify if:
- diagnosis of Epilepsy
- completion of double blind trial
You may not qualify if:
- taking other investigational drug than Lacosamide
- meeting withdrawal criteria from double blind trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB Pharmalead
Study Sites (54)
Unknown Facility
Randwick, New South Wales, Australia
Unknown Facility
Maroochydore, Queensland, Australia
Unknown Facility
Woodville, South Australia, Australia
Unknown Facility
Clayton, Victoria, Australia
Unknown Facility
Parkville, Victoria, Australia
Unknown Facility
West Heidelberg, Victoria, Australia
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Adelaide, Australia
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Zagreb, Croatia
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Brno, Czechia
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Hradec Králové, Czechia
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Olomouc, Czechia
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Ostrava-Trebovice, Czechia
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Pilsen, Czechia
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Prague, Czechia
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Helsinki, Finland
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Kuopio, Finland
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Oulu, Finland
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Tampere, Finland
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Lille, France
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Lyon, France
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Montpellier, France
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Paris, France
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Toulouse, France
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Berlin, Germany
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Erlangen, Germany
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Göttingen, Germany
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Marburg, 35039, Germany
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München, Germany
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Ulm, Germany
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Budapest, Hungary
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Pécs, Hungary
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Szeged, Hungary
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Szombathely, Hungary
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Kaunas, Lithuania
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Vilnius, Lithuania
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Bialystok, Poland
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Gdansk, Poland
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Krakow, Poland
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Warsaw, Poland
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Moscow, Russia
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Saint Petersburg, Russia
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Girona, Spain
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Granada, Spain
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Madrid, Spain
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Zaragoza, Spain
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Gothenburg, Sweden
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Linköping, Sweden
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Stockholm, Sweden
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Cardiff, United Kingdom
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Dundee, United Kingdom
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Glasgow, United Kingdom
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London, United Kingdom
Unknown Facility
Salford, United Kingdom
Unknown Facility
Swansea, United Kingdom
Related Publications (2)
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.
PMID: 24275520RESULTRosenow 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.
PMID: 26133811DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- UCB (Study Director)
- Organization
- UCB Clinical Trial Call Center
Study Officials
- STUDY DIRECTOR
UCB Clinical Trial Call Center
+1 877 822 9493
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 13, 2007
First Posted
August 14, 2007
Study Start
December 1, 2004
Primary Completion
August 1, 2010
Study Completion
August 1, 2010
Last Updated
August 28, 2017
Results First Posted
September 9, 2011
Record last verified: 2017-07