A Pharmacogenomic Exploration of Lacosamide Response

Epilepsy Clinical Trial

Official title:

A Pharmacogenomic Exploration of Lacosamide Response

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01399528
• Other study ID #: RCSI_LCM
• Status: Recruiting
• Phase: N/A
• First received: July 20, 2011
• Last updated: December 5, 2012
• Start date: September 2011
• Est. completion date: March 2014

Study information

• Verified date: December 2012
• Source: Royal College of Surgeons, Ireland
• Contact: Gianpiero Cavalleri, PhD
• Phone: +353 1 4022146
• Email: gcavalleri[@]rcsi.ie
• Is FDA regulated: No
• Health authority: Ireland: Medical Ethics Research Committee
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 660
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Epilepsy

Locations

Country	Name	City	State
Belgium	Hospital Erasme	Brussels
Ireland	Beaumont Hospital	Dublin
Ireland	St.James Hospital	Dublin
United Kingdom	The Institute of Neurology	London
United States	Duke Medical Centre	Durham	North Carolina

Sponsors (5)

Lead Sponsor	Collaborator
Royal College of Surgeons, Ireland	Duke University, Erasme University Hospital, St. James's Hospital, Ireland, University College, London

Countries where clinical trial is conducted

United States,  Belgium,  Ireland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Seizure frequency	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.	Recorded daily by participant. Passed on to study researchers every 3 months for an 18 month period	No
Secondary	Maintenance dose	Maintenance dose will be defined as the tolerated daily dose required by the patient for seizure control.	Recorded every three months for an 18 month period	No
Secondary	Adverse drug reactions	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.	Recorded as reaction arise during the 18 month study period	Yes