eValuation of the Efficacy and toleRability of Vimpat When Added to lEvetiracetam

Epilepsy Clinical Trial

— VERVE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01484977
• Other study ID #: SP0980
• Secondary ID: 2011-002461-37
• Status: Completed
• Phase: Phase 3
• Start date: December 2011
• Est. completion date: December 2013

Study information

• Verified date: July 2017
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Epilepsy

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Australia	075	Chatswood
Australia	079	Parkville
Bulgaria	036	Ruse
Bulgaria	037	Sofia
Bulgaria	080	Sofia
Bulgaria	081	Sofia
Bulgaria	082	Sofia
Denmark	059	Aarhus
Denmark	087	Kobenhavn
France	042	Angers Cedex 1
France	040	Limoges
France	046	Paris
Germany	065	Bielefeld
Germany	066	Hamburg
Germany	068	Tübingen
Romania	096	Bucharest
Romania	099	Bucharest
Romania	097	Lasi
Romania	038	Targu Mures
Romania	095	Targu Mures
Spain	051	Manresa
Spain	053	Oviedo
Spain	050	Sevilla
Sweden	102	Göteborg
United States	002	Akron	Ohio
United States	025	Bradenton	Florida
United States	020	Camden	New Jersey
United States	027	Canton	Ohio
United States	022	Columbus	Ohio
United States	005	Dayton	Ohio
United States	001	Fresno	California
United States	129	Golden Valley	Minnesota
United States	131	Greensboro	North Carolina
United States	006	Hammond	Louisiana
United States	110	Huntsville	Alabama
United States	123	Louisville	Kentucky
United States	028	Lubbock	Texas
United States	139	Madison	Wisconsin
United States	024	Milwaukee	Wisconsin
United States	088	Missoula	Montana
United States	015	Ocala	Florida
United States	013	Oklahoma City	Oklahoma
United States	008	Orange	California
United States	030	Oxnard	California
United States	049	Panama City	Florida
United States	004	Phoenix	Arizona
United States	114	Port Charlotte	Florida
United States	108	Sacramento	California
United States	017	Salt Lake City	Utah
United States	012	Sarasota	Florida
United States	023	Springfield	Missouri
United States	014	Tampa	Florida
United States	112	Waldorf	Maryland
United States	003	Wellington	Florida

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

Countries where clinical trial is conducted

United States,  Australia,  Bulgaria,  Denmark,  France,  Germany,  Romania,  Spain,  Sweden, 

References & 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.1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)

External Links

•   FDA Safety Alerts and Recalls
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