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

September 23, 2016 updated by: Rick McLachlan, Lawson Health Research Institute
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Phase 2

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

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
        • Foothills Medical Center
    • Ontario
      • London, Ontario, Canada, N6A 5A5
        • London Health Sciences Centre
      • Toronto, Ontario, Canada, M5T 2S8
        • Toronto Western Hospital
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 0W8
        • Royal University Hospital

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 to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 100 mg IV
100 mg IV lacosamide infused over 30 minutes
Drug: Lacosamide
Other Names:
  • Vimpat
Other: 200 mg IV
200 mg IV lacosamide infused over 30 minutes
Drug: Lacosamide
Other Names:
  • Vimpat
Other: 400 mg IV
400 mg IV lacosamide infused over 30 minutes
Drug: Lacosamide
Other Names:
  • Vimpat

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in the number of interictal spikes
Time Frame: One hour before and after drug
One hour before and after drug

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in frequency and quantity of background EEG rhythms
Time Frame: One hour before and after drug
One hour before and after drug
Change in EKG (QT, PR interval and heart rhythm)
Time Frame: One hour before and after drug
One hour before and after drug

Other Outcome Measures

Outcome Measure
Time Frame
Adverse events
Time Frame: Up to 4 hours after start of infusion
Up to 4 hours after start of infusion

Collaborators and Investigators

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

Sponsor

Lawson Health Research Institute

Collaborators

UCB Pharma GmbH

Investigators

  • Principal Investigator: Richard McLachlan, MD, FRCPC, London Health Sciences Centre, University Campus

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

May 1, 2013

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

October 31, 2012

First Submitted That Met QC Criteria

November 7, 2012

First Posted (Estimate)

November 12, 2012

Study Record Updates

Last Update Posted (Estimate)

September 26, 2016

Last Update Submitted That Met QC Criteria

September 23, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LIVE 001

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.

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