Lacosamide IV and EEG/EKG (LIVE) Study

Focal Epilepsy Clinical Trial

— LIVE  

Official title:

Lacosamide IV and EEG/EKG (LIVE) Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01724918
• Other study ID #: LIVE 001
• Status: Terminated
• Phase: Phase 2
• First received: October 31, 2012
• Last updated: September 23, 2016
• Start date: May 2013
• Est. completion date: August 2016

Study information

• Verified date: September 2016
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 72
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epilepsies, Partial
• Epilepsy
• Focal Epilepsy

Intervention

Drug:
• Lacosamide

Locations

Country	Name	City	State
Canada	Foothills Medical Center	Calgary	Alberta
Canada	London Health Sciences Centre	London	Ontario
Canada	Royal University Hospital	Saskatoon	Saskatchewan
Canada	Toronto Western Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Lawson Health Research Institute	UCB Pharma GmbH

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse events		Up to 4 hours after start of infusion	Yes
Primary	Change in the number of interictal spikes		One hour before and after drug	No
Secondary	Change in frequency and quantity of background EEG rhythms		One hour before and after drug	No
Secondary	Change in EKG (QT, PR interval and heart rhythm)		One hour before and after drug	Yes