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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01484977




Registration number
NCT01484977
Ethics application status
Date submitted
1/12/2011
Date registered
5/12/2011
Date last updated
18/07/2018

Titles & IDs
Public title
eValuation of the Efficacy and toleRability of Vimpat When Added to lEvetiracetam
Scientific title
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
Secondary ID [1] 0 0
2011-002461-37
Secondary ID [2] 0 0
SP0980
Universal Trial Number (UTN)
Trial acronym
VERVE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Epilepsy 0 0
Condition category
Condition code
Neurological 0 0 0 0
Epilepsy

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - Lacosamide

Experimental: Lacosamide - Lacosamide will be added to levetiracetam while withdrawing the sodium channel blocking antiepileptic drug (AED)


Treatment: Drugs: 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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Retention at the End of the 21-week Treatment Period
Timepoint [1] 0 0
Duration of the Treatment Period (21 Weeks)

Eligibility
Key inclusion criteria
* 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2013
Sample size
Target
Accrual to date
Final
120
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
075 - Chatswood
Recruitment hospital [2] 0 0
079 - Parkville
Recruitment postcode(s) [1] 0 0
- Chatswood
Recruitment postcode(s) [2] 0 0
- Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Kentucky
Country [6] 0 0
United States of America
State/province [6] 0 0
Louisiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Maryland
Country [8] 0 0
United States of America
State/province [8] 0 0
Minnesota
Country [9] 0 0
United States of America
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Missouri
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United States of America
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Montana
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United States of America
State/province [11] 0 0
New Jersey
Country [12] 0 0
United States of America
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North Carolina
Country [13] 0 0
United States of America
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Ohio
Country [14] 0 0
United States of America
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Oklahoma
Country [15] 0 0
United States of America
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Texas
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United States of America
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Utah
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United States of America
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Wisconsin
Country [18] 0 0
Bulgaria
State/province [18] 0 0
Ruse
Country [19] 0 0
Bulgaria
State/province [19] 0 0
Sofia
Country [20] 0 0
Denmark
State/province [20] 0 0
Aarhus
Country [21] 0 0
Denmark
State/province [21] 0 0
Kobenhavn
Country [22] 0 0
France
State/province [22] 0 0
Angers Cedex 1
Country [23] 0 0
France
State/province [23] 0 0
Limoges
Country [24] 0 0
France
State/province [24] 0 0
Paris
Country [25] 0 0
Germany
State/province [25] 0 0
Bielefeld
Country [26] 0 0
Germany
State/province [26] 0 0
Hamburg
Country [27] 0 0
Germany
State/province [27] 0 0
Tübingen
Country [28] 0 0
Romania
State/province [28] 0 0
Bucharest
Country [29] 0 0
Romania
State/province [29] 0 0
Lasi
Country [30] 0 0
Romania
State/province [30] 0 0
Targu Mures
Country [31] 0 0
Spain
State/province [31] 0 0
Manresa
Country [32] 0 0
Spain
State/province [32] 0 0
Oviedo
Country [33] 0 0
Spain
State/province [33] 0 0
Sevilla
Country [34] 0 0
Sweden
State/province [34] 0 0
Göteborg

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
UCB Pharma
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT01484977
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
UCB Clinical Trial Call Center
Address 0 0
877-822-9493
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01484977