Clinical trial NCT01484977: eValuation of the Efficacy and toleRability of Vimpat When Added to lEvetiracetam
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Epilepsy
Keywords: Lacosamide
Epilepsy
Levetiracetam
Sodium Channel Blockers
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2011-12-05
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

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

Primary outcomes:
measure: Retention at the End of the 21-week Treatment Period
timeFrame: Duration of the Treatment Period (21 Weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: 110
state: Alabama
city: Phoenix
country: United States
facility: 004
state: Arizona
city: Fresno
country: United States
facility: 001
state: California
city: Orange
country: United States
facility: 008
state: California
city: Oxnard
country: United States
facility: 030
state: California
city: Sacramento
country: United States
facility: 108
state: California
city: Bradenton
country: United States
facility: 025
state: Florida
city: Ocala
country: United States
facility: 015
state: Florida
city: Panama City
country: United States
facility: 049
state: Florida
city: Port Charlotte
country: United States
facility: 114
state: Florida
city: Sarasota
country: United States
facility: 012
state: Florida
city: Tampa
country: United States
facility: 014
state: Florida
city: Wellington
country: United States
facility: 003
state: Florida
city: Louisville
country: United States
facility: 123
state: Kentucky
city: Hammond
country: United States
facility: 006
state: Louisiana
city: Waldorf
country: United States
facility: 112
state: Maryland
city: Golden Valley
country: United States
facility: 129
state: Minnesota
city: Springfield
country: United States
facility: 023
state: Missouri
city: Missoula
country: United States
facility: 088
state: Montana
city: Camden
country: United States
facility: 020
state: New Jersey
city: Greensboro
country: United States
facility: 131
state: North Carolina
city: Akron
country: United States
facility: 002
state: Ohio
city: Canton
country: United States
facility: 027
state: Ohio
city: Columbus
country: United States
facility: 022
state: Ohio
city: Dayton
country: United States
facility: 005
state: Ohio
city: Oklahoma City
country: United States
facility: 013
state: Oklahoma
city: Lubbock
country: United States
facility: 028
state: Texas
city: Salt Lake City
country: United States
facility: 017
state: Utah
city: Madison
country: United States
facility: 139
state: Wisconsin
city: Milwaukee
country: United States
facility: 024
state: Wisconsin
city: Chatswood
country: Australia
facility: 075
city: Parkville
country: Australia
facility: 079
city: Ruse
country: Bulgaria
facility: 036
city: Sofia
country: Bulgaria
facility: 037
city: Sofia
country: Bulgaria
facility: 080
city: Sofia
country: Bulgaria
facility: 081
city: Sofia
country: Bulgaria
facility: 082
city: Aarhus
country: Denmark
facility: 059
city: Kobenhavn
country: Denmark
facility: 087
city: Angers Cedex 1
country: France
facility: 042
city: Limoges
country: France
facility: 040
city: Paris
country: France
facility: 046
city: Bielefeld
country: Germany
facility: 065
city: Hamburg
country: Germany
facility: 066
city: Tübingen
country: Germany
facility: 068
city: Bucharest
country: Romania
facility: 096
city: Bucharest
country: Romania
facility: 099
city: Lasi
country: Romania
facility: 097
city: Targu Mures
country: Romania
facility: 038
city: Targu Mures
country: Romania
facility: 095
city: Manresa
country: Spain
facility: 051
city: Oviedo
country: Spain
facility: 053
city: Sevilla
country: Spain
facility: 050
city: Göteborg
country: Sweden
facility: 102
Study officials:
affiliation: 877-822-9493
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
citation: 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.