Lacosamide IV and EEG/EKG (LIVE) Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Lawson Health Research Institute
Sponsor:
Collaborator:
UCB Pharma GmbH
Information provided by (Responsible Party):
Rick McLachlan, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01724918
First received: October 31, 2012
Last updated: April 7, 2014
Last verified: July 2013
  Purpose

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 (Subject, 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 Lawson Health Research Institute:

Primary Outcome Measures:
  • Change in the number of interictal spikes [ Time Frame: One hour before and after drug ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in frequency and quantity of background EEG rhythms [ Time Frame: One hour before and after drug ] [ Designated as safety issue: No ]
  • Change in EKG (QT, PR interval and heart rhythm) [ Time Frame: One hour before and after drug ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • Adverse events [ Time Frame: Up to 4 hours after start of infusion ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 90
Study Start Date: May 2013
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01724918

Contacts
Contact: Richard McLachlan, MD, FRCPC 519-663-3293 rsmcl@uwo.ca
Contact: Suzan Brown, BA 519-685-8500 ext 32870 suzan.brown@lhsc.on.ca

Locations
Canada, Alberta
Foothills Medical Center Recruiting
Calgary, Alberta, Canada, T2N 2T9
Principal Investigator: Neelan Pillay, MB, ChB         
Canada, Ontario
London Health Sciences Centre Recruiting
London, Ontario, Canada, N6A 5A5
Principal Investigator: Richard S McLachlan, MD, FRCPC         
Canada, Saskatchewan
Royal University Hospital Recruiting
Saskatoon, Saskatchewan, Canada, S7N 0W8
Principal Investigator: Jose F Tellez-Zenteno, MD         
Sponsors and Collaborators
Lawson Health Research Institute
UCB Pharma GmbH
Investigators
Principal Investigator: Richard McLachlan, MD, FRCPC London Health Sciences Centre, University Campus
  More Information

No publications provided

Responsible Party: Rick McLachlan, Principal Investigator, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01724918     History of Changes
Other Study ID Numbers: LIVE 001
Study First Received: October 31, 2012
Last Updated: April 7, 2014
Health Authority: Canada: Health Canada

Keywords provided by Lawson Health Research Institute:
IV lacosamide
focal epilepsy
EEG
EKG

Additional relevant MeSH terms:
Epilepsy
Epilepsies, Partial
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Lacosamide
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014