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eValuation of the Efficacy and toleRability of Vimpat When Added to lEvetiracetam (VERVE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01484977
Recruitment Status : Completed
First Posted : December 5, 2011
Results First Posted : November 26, 2014
Last Update Posted : July 18, 2018
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Tracking Information
First Submitted Date  ICMJE December 1, 2011
First Posted Date  ICMJE December 5, 2011
Results First Submitted Date  ICMJE November 20, 2014
Results First Posted Date  ICMJE November 26, 2014
Last Update Posted Date July 18, 2018
Study Start Date  ICMJE December 2011
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 20, 2014)
Retention at the End of the 21-week Treatment Period [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 2, 2011)
Retention at the end the 21-week Treatment Period. [ Time Frame: 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.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE eValuation of the Efficacy and toleRability of Vimpat When Added to lEvetiracetam
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Epilepsy
Intervention  ICMJE 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.

Other Names:
  • VIMPAT®
  • SPM927
  • Harkoseride
Study Arms  ICMJE Experimental: Lacosamide
Lacosamide will be added to levetiracetam while withdrawing the sodium channel blocking antiepileptic drug (AED)
Intervention: Drug: Lacosamide
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 14, 2014)
120
Original Estimated Enrollment  ICMJE
 (submitted: December 2, 2011)
300
Actual Study Completion Date  ICMJE December 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Bulgaria,   Denmark,   France,   Germany,   Romania,   Spain,   Sweden,   United States
Removed Location Countries Austria,   Canada,   Hungary,   Switzerland,   United Kingdom
 
Administrative Information
NCT Number  ICMJE NCT01484977
Other Study ID Numbers  ICMJE SP0980
2011-002461-37 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party UCB Pharma
Study Sponsor  ICMJE UCB Pharma
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: UCB Clinical Trial Call Center 877-822-9493
PRS Account UCB Pharma
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP