A Pharmacogenomic Exploration of Lacosamide Response

This study is currently recruiting participants.
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

July 20, 2011
December 5, 2012
September 2011
March 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01399528 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
A Pharmacogenomic Exploration of Lacosamide Response
A Pharmacogenomic Exploration of Lacosamide Response

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
Not Provided
Observational
Observational Model: Cohort
Not Provided
Retention:   Samples With DNA
Description:

Collecting DNA from blood samples

Non-Probability Sample

patients with epilepsy recruited from five tertiary referral centres.

Epilepsy
Not Provided
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
660
March 2014
March 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact: Gianpiero Cavalleri, PhD +353 1 4022146 gcavalleri@rcsi.ie
United States,   Belgium,   Ireland,   United Kingdom
 
NCT01399528
RCSI_LCM
No
Norman Delanty, Royal College of Surgeons, Ireland
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
Royal College of Surgeons, Ireland
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP