A Pharmacogenomic Exploration of Lacosamide Response
This study is currently recruiting participants.
Verified December 2012 by Royal College of Surgeons, Ireland
Sponsor:
Royal College of Surgeons, Ireland
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
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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:
Genetics Home Reference related topics:
pyridoxal 5'-phosphate-dependent epilepsy
Drug Information available for:
Lacosamide
U.S. FDA Resources
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
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 |
Additional relevant MeSH terms:
|
Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases |
ClinicalTrials.gov processed this record on May 21, 2013