A Pharmacogenomic Exploration of Lacosamide Response

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Royal College of Surgeons, Ireland
Sponsor:
Collaborators:
St. James's Hospital, Ireland
University College, London
Erasme University Hospital
Duke University
Information provided by (Responsible Party):
Norman Delanty, Royal College of Surgeons, Ireland
ClinicalTrials.gov Identifier:
NCT01399528
First received: July 20, 2011
Last updated: December 5, 2012
Last verified: December 2012
  Purpose

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
Epilepsy

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: A Pharmacogenomic Exploration of Lacosamide Response

Resource links provided by NLM:


Further study details as provided by Royal College of Surgeons, Ireland:

Primary Outcome Measures:
  • Seizure frequency [ Time Frame: Recorded daily by participant. Passed on to study researchers every 3 months for an 18 month period ] [ Designated as safety issue: No ]
    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:
  • Maintenance dose [ Time Frame: Recorded every three months for an 18 month period ] [ Designated as safety issue: No ]
    Maintenance dose will be defined as the tolerated daily dose required by the patient for seizure control.

  • Adverse drug reactions [ Time Frame: Recorded as reaction arise during the 18 month study period ] [ Designated as safety issue: Yes ]
    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


Estimated Enrollment: 660
Study Start Date: September 2011
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Groups/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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients with epilepsy recruited from five tertiary referral centres.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01399528

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

Locations
United States, North Carolina
Duke Medical Centre Recruiting
Durham, North Carolina, United States
Contact: Saraubh Sinha         
Belgium
Hospital Erasme Recruiting
Brussels, Belgium
Contact: Chantal Depondt         
Ireland
St.James Hospital Recruiting
Dublin, Ireland
Contact: Colin Doherty         
Beaumont Hospital Recruiting
Dublin, Ireland, D4
Contact: Gianpiero Cavalleri, PhD    +353 1 4022146    gcavalleri@rcsi.ie   
Principal Investigator: Norman Delanty         
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
Investigators
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

No publications provided

Responsible Party: Norman Delanty, Consultant Neurologist, Royal College of Surgeons, Ireland
ClinicalTrials.gov Identifier: NCT01399528     History of Changes
Other Study ID Numbers: RCSI_LCM
Study First Received: July 20, 2011
Last Updated: December 5, 2012
Health Authority: Ireland: Medical Ethics Research Committee

ClinicalTrials.gov processed this record on September 30, 2014