eValuation of the Efficacy and toleRability of Vimpat When Added to lEvetiracetam
- Registration Number
- NCT01484977
- Lead Sponsor
- UCB Pharma
- Brief Summary
The main purpose of this study is to evaluate the effectiveness of the study drug lacosamide (200-600 mg/day) when added to a stable dose of levetiracetam (1000-3000 mg/day) with withdrawal of the concomitant sodium channel blocking-antiepileptic drug (AEDs) in subjects not well controlled on their current regimen.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- Subject is male or female, at least 18 years of age
- 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
- Previous use of lacosamide
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Lacosamide Lacosamide Lacosamide will be added to levetiracetam while withdrawing the sodium channel blocking antiepileptic drug (AED)
- Primary Outcome Measures
Name Time Method Retention at the End of the 21-week Treatment Period Duration of the Treatment Period (21 Weeks) Retention is a summary measure that integrates both the patient's and clinician's assessment of efficacy and tolerability in epilepsy clinical studies to provide a measure of effectiveness.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (54)
001
🇺🇸Fresno, California, United States
036
🇧🇬Ruse, Bulgaria
046
🇫🇷Paris, France
024
🇺🇸Milwaukee, Wisconsin, United States
081
🇧🇬Sofia, Bulgaria
139
🇺🇸Madison, Wisconsin, United States
002
🇺🇸Akron, Ohio, United States
080
🇧🇬Sofia, Bulgaria
040
🇫🇷Limoges, France
075
🇦🇺Chatswood, Australia
051
🇪🇸Manresa, Spain
028
🇺🇸Lubbock, Texas, United States
050
🇪🇸Sevilla, Spain
102
🇸🇪Göteborg, Sweden
053
🇪🇸Oviedo, Spain
004
🇺🇸Phoenix, Arizona, United States
017
🇺🇸Salt Lake City, Utah, United States
087
🇩🇰Kobenhavn, Denmark
110
🇺🇸Huntsville, Alabama, 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
123
🇺🇸Louisville, Kentucky, United States
003
🇺🇸Wellington, Florida, United States
023
🇺🇸Springfield, Missouri, United States
112
🇺🇸Waldorf, Maryland, United States
129
🇺🇸Golden Valley, Minnesota, United States
088
🇺🇸Missoula, Montana, United States
020
🇺🇸Camden, New Jersey, United States
131
🇺🇸Greensboro, North Carolina, United States
027
🇺🇸Canton, Ohio, United States
022
🇺🇸Columbus, Ohio, United States
005
🇺🇸Dayton, Ohio, United States
079
🇦🇺Parkville, Australia
059
🇩🇰Aarhus, Denmark
042
🇫🇷Angers Cedex 1, France
066
🇩🇪Hamburg, Germany
068
🇩🇪Tübingen, Germany
096
🇷🇴Bucharest, Romania
099
🇷🇴Bucharest, Romania
013
🇺🇸Oklahoma City, Oklahoma, United States
082
🇧🇬Sofia, Bulgaria
006
🇺🇸Hammond, Louisiana, United States
037
🇧🇬Sofia, Bulgaria
097
🇷🇴Lasi, Romania
095
🇷🇴Targu Mures, Romania
038
🇷🇴Targu Mures, Romania
065
🇩🇪Bielefeld, Germany