NCT01399528

A Pharmacogenomic Exploration of Lacosamide Response

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 660 (estimated)
• Sponsor: Royal College of Surgeons, Ireland · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Conditions

• Epilepsy

Timeline

• Start date: 2011-09-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2011-07-21
• Last updated: 2012-12-07

Locations

5 sites across 4 countries: United States, Belgium, Ireland, United Kingdom