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A Pharmacogenomic Exploration of Lacosamide Response

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ClinicalTrials.gov Identifier: NCT01399528
Recruitment Status : Unknown
Verified December 2012 by Norman Delanty, Royal College of Surgeons, Ireland.
Recruitment status was:  Recruiting
First Posted : July 21, 2011
Last Update Posted : December 7, 2012
Information provided by (Responsible Party):

Study Description
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

Condition or disease

Study Design

Study Type : Observational
Estimated Enrollment : 660 participants
Observational Model: Cohort
Official Title: A Pharmacogenomic Exploration of Lacosamide Response
Study Start Date : September 2011
Estimated Primary Completion Date : March 2014
Estimated Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Lacosamide
U.S. FDA Resources

Groups and Cohorts

Beaumont Hospital, Dublin, Ireland
St. James' Hospital, Dublin, Ireland
Hôpital Erasme, Brussels, Belgium
Duke Medical Centre, North Carolina, USA
The Institute of Neurology/University College London, UK

Outcome Measures

Primary Outcome Measures :
  1. Seizure frequency [ Time Frame: 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 :
  1. Maintenance dose [ Time Frame: 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.

  2. Adverse drug reactions [ Time Frame: 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.

Biospecimen Retention:   Samples With DNA
Collecting DNA from blood samples

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with epilepsy recruited from five tertiary referral centres.

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01399528

Contact: Gianpiero Cavalleri, PhD +353 1 4022146 gcavalleri@rcsi.ie

United States, North Carolina
Duke Medical Centre Recruiting
Durham, North Carolina, United States
Contact: Saraubh Sinha         
Hospital Erasme Recruiting
Brussels, Belgium
Contact: Chantal Depondt         
Beaumont Hospital Recruiting
Dublin, Ireland, D4
Contact: Gianpiero Cavalleri, PhD    +353 1 4022146    gcavalleri@rcsi.ie   
Principal Investigator: Norman Delanty         
St.James Hospital Recruiting
Dublin, Ireland
Contact: Colin Doherty         
United Kingdom
The Institute of Neurology Recruiting
London, United Kingdom
Contact: Sanjay Sisodiya         
Sponsors and Collaborators
Royal College of Surgeons, Ireland
St. James's Hospital, Ireland
University College, London
Erasme University Hospital
Duke University
Principal Investigator: Norman Delanty, MB FRCPI Beaumont Hospital and Royal College of Surgeons in Ireland
Principal Investigator: Gianpiero L Cavalleri, PhD Royal College of Surgeons in Ireland
More Information

Responsible Party: Norman Delanty, Consultant Neurologist, Royal College of Surgeons, Ireland
ClinicalTrials.gov Identifier: NCT01399528     History of Changes
Other Study ID Numbers: RCSI_LCM
First Posted: July 21, 2011    Key Record Dates
Last Update Posted: December 7, 2012
Last Verified: December 2012

Additional relevant MeSH terms: