A Pharmacogenomic Exploration of Lacosamide Response

• Conditions: Epilepsy

• Registration Number: NCT01399528
• Lead Sponsor: Royal College of Surgeons, Ireland

Brief Summary

This is an observational study exploring the genetics of lacosamide response. The study will last 3 years and has been divided in to three stages; 1) recruitment, 2) observational phase, 3) genotyping and analysis. Patients initiating lacosamide are recruited and their baseline seizure frequency is assessed retrospectively. Patients are then monitored for 18 months with an assessment (via interview and where possible seizure diaries) of seizure frequency and other treatment related phenotypes every 3 months. The recruitment period will span months 1-12, the observational period will span months 1-30 and analysis of data will be conducted between months 30-36 (see Figure 2 below). Target sample size is 610.

Primary objective: To determine the clinical relevance of genetic variation in predicting lacosamide responsive and non-responsive patients.

Secondary objectives: To determine the clinical relevance of genetic variation in predicting:

* Optimal dose of lacosamide

* Adverse drug reactions to lacosamide

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-07-20
• Study First Submitted QC: 2011-07-20
• Study First Posted: 2011-07-21
• Study Start: 2011-09
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-05
• Last Update Posted: 2012-12-07
• Primary Completion: 2014-03
• Study Completion: 2014-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 660

Inclusion Criteria

• Diagnosed with partial onset seizures (simple and/or complex) with or without secondary generalization (based on 1981 ILAE seizure classification scheme)
• Over 18 and under 65 years of age at date of recruitment in to the study
• Currently undergoing pharmacological treatment for refractory partial epilepsy ('refractory' here refers to patients who continue to have seizures despite treatment (current) with two or more appropriate anti-epileptic drugs at appropriate doses)
• Deemed suitable for treatment with lacosamide (following drug guidelines)

Exclusion Criteria

• Patients experiencing seizure type other than partial onset seizures (with/without secondary generalisation)
• Patients with a history of chronic alcohol or drug abuse within previous 3 years.
• Non refractory epilepsy patients
• Patients suffering any other clinically significant disease e.g. cancers, progressive neurological disorder, heart failure, respiratory failure etc
• Patients who are pregnant or who are intending on getting pregnant within the period of the trial.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Seizure frequency	Recorded daily by participant. Passed on to study researchers every 3 months for an 18 month period	We will record seizure type and frequency. Seizure types will follow definitions as provided by the International League Against Epilepsy. Seizure frequency will be as recorded by the participant in a seizure diary.

Secondary Outcome Measures

Name	Time	Method
Maintenance dose	Recorded every three months for an 18 month period	Maintenance dose will be defined as the tolerated daily dose required by the patient for seizure control.
Adverse drug reactions	Recorded as reaction arise during the 18 month study period	We will record any adverse reactions recorded by the study participant, including for example (but not limited to): dizziness, ataxia, vomiting, diplopia, nausea, vertigo, and vision blurred.

Trial Locations

Locations (5)

Duke Medical Centre; 🇺🇸 Durham, North Carolina, United States

Hospital Erasme; 🇧🇪 Brussels, Belgium

The Institute of Neurology; 🇬🇧 London, United Kingdom

Beaumont Hospital; 🇮🇪 Dublin, Ireland

St.James Hospital; 🇮🇪 Dublin, Ireland