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

This study has been terminated.
(Time limitation for recruitment exceeded. 72 of 90 estimated sample recruited.)
UCB Pharma GmbH
Information provided by (Responsible Party):
Rick McLachlan, Lawson Health Research Institute Identifier:
First received: October 31, 2012
Last updated: September 23, 2016
Last verified: September 2016
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.

Condition Intervention Phase
Focal Epilepsy
Drug: Lacosamide
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Lacosamide IV and EEG/EKG (LIVE) Study

Resource links provided by NLM:

Further study details as provided by Rick McLachlan, Lawson Health Research Institute:

Primary Outcome Measures:
  • Change in the number of interictal spikes [ Time Frame: One hour before and after drug ]

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

Other Outcome Measures:
  • Adverse events [ Time Frame: Up to 4 hours after start of infusion ]

Enrollment: 72
Study Start Date: May 2013
Study Completion Date: August 2016
Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
100 mg IV
100 mg IV lacosamide infused over 30 minutes
Drug: Lacosamide
Other Name: Vimpat
200 mg IV
200 mg IV lacosamide infused over 30 minutes
Drug: Lacosamide
Other Name: Vimpat
400 mg IV
400 mg IV lacosamide infused over 30 minutes
Drug: Lacosamide
Other Name: Vimpat

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.

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01724918

Canada, Alberta
Foothills Medical Center
Calgary, Alberta, Canada, T2N 2T9
Canada, Ontario
London Health Sciences Centre
London, Ontario, Canada, N6A 5A5
Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8
Canada, Saskatchewan
Royal University Hospital
Saskatoon, Saskatchewan, Canada, S7N 0W8
Sponsors and Collaborators
Lawson Health Research Institute
UCB Pharma GmbH
Principal Investigator: Richard McLachlan, MD, FRCPC London Health Sciences Centre, University Campus
  More Information

Responsible Party: Rick McLachlan, Principal Investigator, Lawson Health Research Institute Identifier: NCT01724918     History of Changes
Other Study ID Numbers: LIVE 001
Study First Received: October 31, 2012
Last Updated: September 23, 2016

Keywords provided by Rick McLachlan, Lawson Health Research Institute:
IV lacosamide
focal epilepsy

Additional relevant MeSH terms:
Epilepsies, Partial
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Anticonvulsants processed this record on May 25, 2017