A Pharmacogenomic Exploration of Lacosamide Response

Status Recruiting

Clinical Trial 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

Clinical Trial Description

n/a

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

Epilepsy

Clinical Trial Details

NCT number	NCT01399528
Study type	Observational
Source	Royal College of Surgeons, Ireland
Contact	Gianpiero Cavalleri, PhD
Phone	+353 1 4022146
Email	gcavalleri@rcsi.ie
Status	Recruiting
Phase	N/A
Start date	September 2011
Completion date	March 2014

View Details

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