Clinical trial NCT01399528: A Pharmacogenomic Exploration of Lacosamide Response
Official title: A Pharmacogenomic Exploration of Lacosamide Response
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Epilepsy
Lead sponsor: Royal College of Surgeons, Ireland
Sponsor class: OTHER
Collaborators: name: St. James's Hospital, Ireland
name: University College, London
name: Erasme University Hospital
name: Duke University
First posted: 2011-07-21
Enrollment: 660
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with epilepsy recruited from five tertiary referral centres.

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


Eligibility 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.

Primary outcomes:
measure: Seizure frequency
timeFrame: Recorded daily by participant. Passed on to study researchers every 3 months for an 18 month period
Secondary outcomes:
measure: Maintenance dose
timeFrame: Recorded every three months for an 18 month period
measure: Adverse drug reactions
timeFrame: Recorded as reaction arise during the 18 month study period
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Medical Centre
state: North Carolina
city: Brussels
country: Belgium
facility: Hospital Erasme
city: Dublin
country: Ireland
facility: Beaumont Hospital
city: Dublin
country: Ireland
facility: St.James Hospital
city: London
country: United Kingdom
facility: The Institute of Neurology
Study officials:
affiliation: Beaumont Hospital and Royal College of Surgeons in Ireland
name: Norman Delanty, MB FRCPI
role: PRINCIPAL_INVESTIGATOR
affiliation: Royal College of Surgeons in Ireland
name: Gianpiero L Cavalleri, PhD
role: PRINCIPAL_INVESTIGATOR
References: