eValuation of the Efficacy and toleRability of Vimpat When Added to lEvetiracetam
VERVE
Open-label, Single Arm, Study Evaluating Tolerability and Efficacy of Lacosamide When Added to Levetiracetam With Withdrawal of Concomitant Sodium Channel Blocking Antiepileptic Drug in Subjects With Uncontrolled Partial-onset Seizures
2 other identifiers
interventional
120
9 countries
54
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Dec 2011
54 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 1, 2011
CompletedStudy Start
First participant enrolled
December 1, 2011
CompletedFirst Posted
Study publicly available on registry
December 5, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedResults Posted
Study results publicly available
November 26, 2014
CompletedJuly 18, 2018
July 1, 2017
2 years
December 1, 2011
November 20, 2014
June 21, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Retention at the End of the 21-week Treatment Period
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.
Duration of the Treatment Period (21 Weeks)
Study Arms (1)
Lacosamide
EXPERIMENTALLacosamide will be added to levetiracetam while withdrawing the sodium channel blocking antiepileptic drug (AED)
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB Pharmalead
Study Sites (54)
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
Related Publications (1)
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.
PMID: 27714769RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- UCB Clinical Trial Call Center
Study Officials
- STUDY DIRECTOR
UCB Clinical Trial Call Center
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
- Expanded Access
- Yes
Study Record Dates
First Submitted
December 1, 2011
First Posted
December 5, 2011
Study Start
December 1, 2011
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
July 18, 2018
Results First Posted
November 26, 2014
Record last verified: 2017-07