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A Pharmacogenomic Exploration of Lacosamide Response

NCT01399528 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 660

Last updated 2012-12-07

No results posted yet for this study

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

Sponsors & Collaborators

  • St. James's Hospital, Ireland

    collaborator OTHER

  • University College, London

    collaborator OTHER

  • Erasme University Hospital

    collaborator OTHER

  • Duke University

    collaborator OTHER

  • Royal College of Surgeons, Ireland

    lead OTHER

Principal Investigators

  • Norman Delanty, MB FRCPI · Beaumont Hospital and Royal College of Surgeons in Ireland

  • Gianpiero L Cavalleri, PhD · Royal College of Surgeons in Ireland

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2014-03-31
Completion
2014-03-31

Countries

  • United States
  • Belgium
  • Ireland
  • United Kingdom

Study Locations

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01399528 on ClinicalTrials.gov