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

June 21, 2018 updated by: UCB Pharma

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 3

Expanded Access

No longer available outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Lacosamide
Lacosamide will be added to levetiracetam while withdrawing the sodium channel blocking antiepileptic drug (AED)
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:
  • Harkoseride
  • VIMPAT®
  • SPM927

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Duration of the Treatment Period (21 Weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UCB Pharma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (ACTUAL)

December 1, 2013

Study Completion (ACTUAL)

December 1, 2013

Study Registration Dates

First Submitted

December 1, 2011

First Submitted That Met QC Criteria

December 2, 2011

First Posted (ESTIMATE)

December 5, 2011

Study Record Updates

Last Update Posted (ACTUAL)

July 18, 2018

Last Update Submitted That Met QC Criteria

June 21, 2018

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SP0980
  • 2011-002461-37 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Epilepsy

Clinical Trials on Lacosamide

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Suriname

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe