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Lacosamide IV and EEG/EKG (LIVE) Study (LIVE)

Primary Purpose

Focal Epilepsy

Status
Terminated
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Lacosamide
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Focal Epilepsy focused on measuring IV lacosamide, focal epilepsy, EEG, EKG

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Subject is informed and given ample time and opportunity to think about her/his participation and has given her/his written informed consent.
  2. Adult patients 18-65 years
  3. Diagnosis of focal epilepsy
  4. Continuous EEG and video monitoring
  5. Continuous EKG
  6. Active EEG showing frequent spikes, electrographic or clinical seizures

Exclusion Criteria:

  1. Subject has no IV access.
  2. Subject is hemodynamically unstable.
  3. Previous use of Lacosamide
  4. Primary generalized epilepsy
  5. Non-epileptic seizures
  6. No significant cardiac, renal or hepatic disease
  7. No cardiac arrhythmias including heart block
  8. Subject is a pregnant or lactating woman.

Sites / Locations

  • Foothills Medical Center
  • London Health Sciences Centre
  • Toronto Western Hospital
  • Royal University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

100 mg IV

200 mg IV

400 mg IV

Arm Description

100 mg IV lacosamide infused over 30 minutes

200 mg IV lacosamide infused over 30 minutes

400 mg IV lacosamide infused over 30 minutes

Outcomes

Primary Outcome Measures

Change in the number of interictal spikes

Secondary Outcome Measures

Change in frequency and quantity of background EEG rhythms
Change in EKG (QT, PR interval and heart rhythm)

Full Information

First Posted
October 31, 2012
Last Updated
September 23, 2016
Sponsor
Lawson Health Research Institute
Collaborators
UCB Pharma GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT01724918
Brief Title
Lacosamide IV and EEG/EKG (LIVE) Study
Acronym
LIVE
Official Title
Lacosamide IV and EEG/EKG (LIVE) Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Terminated
Why Stopped
Time limitation for recruitment exceeded. 72 of 90 estimated sample recruited.
Study Start Date
May 2013 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lawson Health Research Institute
Collaborators
UCB Pharma GmbH

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the effect of different intravenous doses (IV) of a new anti-epileptic drug (AED) called lacosamide on continuous EEG (electroencephalogram) rhythms (or brain rhythms) in subjects with focal seizures and the tolerability of those doses by patients. In addition, this study will assess the effect of IV lacosamide on EKG (electrocardiogram), a test which checks for problems with the electrical activity of the heart.
Detailed Description
The impact of antiepileptic drugs on the EEG can vary from marked to none. A small number of AEDs also affect the EKG. Lacosamide is a new AED that selectively enhances slow inactivation of voltage-gated sodium channels, resulting in stabilization of hyperexcitable neuronal membranes and inhibition of repetitive neuronal firing. Information is lacking about the effect of lacosamide on brain and heart rhythms.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Focal Epilepsy
Keywords
IV lacosamide, focal epilepsy, EEG, EKG

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
100 mg IV
Arm Type
Other
Arm Description
100 mg IV lacosamide infused over 30 minutes
Arm Title
200 mg IV
Arm Type
Other
Arm Description
200 mg IV lacosamide infused over 30 minutes
Arm Title
400 mg IV
Arm Type
Other
Arm Description
400 mg IV lacosamide infused over 30 minutes
Intervention Type
Drug
Intervention Name(s)
Lacosamide
Other Intervention Name(s)
Vimpat
Primary Outcome Measure Information:
Title
Change in the number of interictal spikes
Time Frame
One hour before and after drug
Secondary Outcome Measure Information:
Title
Change in frequency and quantity of background EEG rhythms
Time Frame
One hour before and after drug
Title
Change in EKG (QT, PR interval and heart rhythm)
Time Frame
One hour before and after drug
Other Pre-specified Outcome Measures:
Title
Adverse events
Time Frame
Up to 4 hours after start of infusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject is informed and given ample time and opportunity to think about her/his participation and has given her/his written informed consent. Adult patients 18-65 years Diagnosis of focal epilepsy Continuous EEG and video monitoring Continuous EKG Active EEG showing frequent spikes, electrographic or clinical seizures Exclusion Criteria: Subject has no IV access. Subject is hemodynamically unstable. Previous use of Lacosamide Primary generalized epilepsy Non-epileptic seizures No significant cardiac, renal or hepatic disease No cardiac arrhythmias including heart block Subject is a pregnant or lactating woman.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard McLachlan, MD, FRCPC
Organizational Affiliation
London Health Sciences Centre, University Campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Foothills Medical Center
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2T9
Country
Canada
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
Toronto Western Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
Facility Name
Royal University Hospital
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 0W8
Country
Canada

12. IPD Sharing Statement

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Lacosamide IV and EEG/EKG (LIVE) Study

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