Abstracts

Rationale: Lacosamide (LCM) is a new anti-seizure drug with a novel mode of action (slow sodium channel blockade), approved in the US, Europe and other countries but not yet in Canada, as adjunct therapy for focal-onset seizures. Canadian Health authorities allow the use of drugs yet to be approved or not marketed in Canada through a Special Access Program (SAP). This requires a physician s submission to Health Canada and the company responsible for the manufacturing of the drug on a per-patient basis, allowing for accurate monitoring of drug distribution, reporting of side effects and efficacy. Drug companies provide the drug free of cost pending approval. Clinical trials often do not reflect real-world practices. Assessing the performance of LCM as utilized by a group of epileptologists of different backgrounds and dealing with diverse patient populations provides a unique opportunity to evaluate this drug outside the rarefied structure of a clinical trial. Methods: The drug manufacturer (UCB Canada) was approached to provide the names of practitioners requesting LCM through the SAP. All patients registered in SAP were compiled and their epileptologists contacted to provide details of age, gender, length of therapy, seizure types, response to treatment, side effects (SEs) and type of imaging changes. Results: Of 57 patients in the SAP, 47 have received LCM for a minimum of 1 month and a maximum of 8. There are 28 females. Age range is 10-63 (median 27.5). Two were on 1 additional AED, 16 on 2, 14 on 3 and 17 on 4 or more. Eight patients have had a surgical procedure and 13 have a VNS device. Forty-two percent had normal MRI. Seizure frequency ranged between 1 - 600 seizures/month (mean: 43). Eight patients had partial complex as the only seizure type. The average dose of LCM is 300 mg/day (50-600). Eight patients experienced no improvement. Only 2 discontinued treatment due to SEs (one with panic attacks and the other due to nausea, headache and dizziness) and 2 due to inefficacy. Four are up-titrating. Thirteen patients experienced a >50% improvement (2 seizure-free). The remainder had some improvement or are still up-titrating. SEs were reported by 50%, generally transient, mostly dizziness, sedation, nausea and headache. Conclusions: In this highly refractory group of patients of varying ages and etiologies, LCM provided worthwhile improvement in 25% (2 patients seizure-free). SEs were common but usually transient and well tolerated. Some patients derived benefit in doses as low as 50 mg/day. The observational study is ongoing to collect a larger cohort and follow up over longer period. Aggregate data will be added to this report.