eValuation of the Efficacy and toleRability of Vimpat When Added to lEvetiracetam
NCT ID: NCT01484977
Last Updated: 2018-07-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
120 participants
INTERVENTIONAL
2011-12-31
2013-12-31
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
Lacosamide will be added to levetiracetam while withdrawing the sodium channel blocking antiepileptic drug (AED)
Lacosamide
50 mg and 100 mg lacosamide tablets will be combined and taken in two equal doses per day to provide the required total daily dosage of 100 - 600 mg/day. Subjects were titrated to a minimum of 200 mg/ day during the Treatment Period.
Maximum duration of study drug administration is approximately 23 weeks.
Interventions
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Lacosamide
50 mg and 100 mg lacosamide tablets will be combined and taken in two equal doses per day to provide the required total daily dosage of 100 - 600 mg/day. Subjects were titrated to a minimum of 200 mg/ day during the Treatment Period.
Maximum duration of study drug administration is approximately 23 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject has a diagnosis of epilepsy with partial-onset seizures according to the International Classification of Epileptic Seizures (1981)
* Subject is taking levetiracetam (LEV) in combination with 1 sodium channel blocking antiepileptic drug (defined as carbamazepine, lamotrigine, oxcarbazepine, phenytoin, or eslicarbazepine) as adjunctive treatment for epilepsy
* The minimum required seizure frequency during the 8-week Retrospective Seizure Baseline is on average ≥ 2 partial-onset seizures per 28 days with at least 1 seizure per 4 week period within the 8-week Retrospective Seizure Baseline. Additionally, subjects must experience at least 1 seizure during the 4-week Prospective Seizure Baseline
* Subject has been maintained on a stable dose of LEV and a sodium channel blocking antiepileptic drug (SCB-AED) for at least 4 weeks prior to the Screening Visit (Visit 1) and during the 4-week Prospective Seizure Baseline
* The minimum required seizure frequency during the 8-week Retrospective Seizure Baseline is on average ≥ 2 partial-onset seizures per 28 days (based on investigator assessment of subject report) with at least 1 seizure per 4 week period within the 8-week Retrospective Seizure Baseline
* Subject has been maintained on a stable dose of levetiracetam (LEV) and a sodium channel blocking antiepileptic drug (SCB-AED) for at least 4 weeks prior to the Screening Visit (Visit 1) and during the 4-week Prospective Seizure Baseline, with or without additional concurrent stable vagal nerve stimulation (VNS). The VNS must have been in place for at least 6 months prior to the Screening Visit (Visit 1) with constant settings for at least 4-weeks prior to the Screening Visit (Visit 1) and throughout the duration of the study
Exclusion Criteria
* History of alcohol or drug abuse
* History of seizure disorder characterized primarily by isolated auras
* History of primary generalized seizures
* History of status epilepticus within the 12-months
* History of clustering seizures
* Nonepileptic events, including pseudoseizures that could be confused with seizures
* History of any medical or psychiatric condition that, in the opinion of the investigator, could jeopardize the subject's health or would compromise the subject's ability to participate in this study
* Lifetime history of suicide attempt, or suicidal ideation in the past 6 months
* Hypersensitivity to any component of lacosamide (LCM)
* History of acute or sub-acute progressive central nervous system disease
* History of severe anaphylactic reaction or serious blood dyscrasias
* Impaired renal function (ie, Creatinine Clearance (CLcr) is lower than 30 mL/min) at Visit 1
* History of sick sinus syndrome without a pacemaker, or atrioventricular (AV) block, or subject has any other clinically significant electrocardiogram (ECG) abnormalities
* History sodium channelopathy, such as Brugada syndrome
* History of myocardial infarction in the last 3 months
18 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
877-822-9493
Locations
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110
Huntsville, Alabama, United States
004
Phoenix, Arizona, United States
001
Fresno, California, United States
008
Orange, California, United States
030
Oxnard, California, United States
108
Sacramento, California, United States
025
Bradenton, Florida, United States
015
Ocala, Florida, United States
049
Panama City, Florida, United States
114
Port Charlotte, Florida, United States
012
Sarasota, Florida, United States
014
Tampa, Florida, United States
003
Wellington, Florida, United States
123
Louisville, Kentucky, United States
006
Hammond, Louisiana, United States
112
Waldorf, Maryland, United States
129
Golden Valley, Minnesota, United States
023
Springfield, Missouri, United States
088
Missoula, Montana, United States
020
Camden, New Jersey, United States
131
Greensboro, North Carolina, United States
002
Akron, Ohio, United States
027
Canton, Ohio, United States
022
Columbus, Ohio, United States
005
Dayton, Ohio, United States
013
Oklahoma City, Oklahoma, United States
028
Lubbock, Texas, United States
017
Salt Lake City, Utah, United States
139
Madison, Wisconsin, United States
024
Milwaukee, Wisconsin, United States
075
Chatswood, , Australia
079
Parkville, , Australia
036
Rousse, , Bulgaria
037
Sofia, , Bulgaria
080
Sofia, , Bulgaria
081
Sofia, , Bulgaria
082
Sofia, , Bulgaria
059
Aarhus, , Denmark
087
Copenhagen, , Denmark
042
Angers, , France
040
Limoges, , France
046
Paris, , France
065
Bielefeld, , Germany
066
Hamburg, , Germany
068
Tübingen, , Germany
096
Bucharest, , Romania
099
Bucharest, , Romania
097
Lasi, , Romania
038
Târgu Mureş, , Romania
095
Târgu Mureş, , Romania
051
Manresa, , Spain
053
Oviedo, , Spain
050
Seville, , Spain
102
Gothenburg, , Sweden
Countries
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References
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Baulac M, Byrnes W, Williams P, Borghs S, Webster E, De Backer M, Dedeken P. Lacosamide and sodium channel-blocking antiepileptic drug cross-titration against levetiracetam background therapy. Acta Neurol Scand. 2017 Apr;135(4):434-441. doi: 10.1111/ane.12691. Epub 2016 Oct 6.
Related Links
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FDA Safety Alerts and Recalls
Other Identifiers
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2011-002461-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
SP0980
Identifier Type: -
Identifier Source: org_study_id
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