American Academy of Neurology (AAN) 65th Annual Meeting: Page 2 of 2

May 15, 2013

Rosenfeld and colleagues pooled data from OLE trials NCT00522275, NCT00552305, and NCT00515619, which cumulatively included 1054 adults with partial-onset seizures who completed a lead-in trial of adjunctive lacosamide, and they evaluated the outcomes for the subset of patients who were 65 years and older. This included 33 (3.1%) patients who were at least 65 years of age by the end of the OLE studies.

Of these 33 patients, 21 (63.6%) completed the OLE trials, 18 (85.7%) of who continued on to receive commercial lacosamide treatment. The mean and maximum lacosamide treatment durations were 1563.2 and 2790.0 days, respectively, with a median modal dose of 400-mg daily. All patients had an opportunity to receive at least 3 years (and up to 8 years) of open-label lacosamide treatment, and after 1, 3, and 5 years of this treatment, 90.9%, 75.8%, and 42.4% of elderly patients remained in the trial, respectively.

Patients who discontinued treatment did so primarily because of adverse events (n=4; 12.1%), lack of efficacy (n=3; 9.1%), and consent withdrawal (n=2; 6.1%). The median percent reduction in seizure frequency from baseline was 62.5%, 58.2%, and 66.6% after 1, 3, and 5 years, respectively. Reported adverse effects included dizziness (n=12; 36.4%); falls (n=9; 27.3%); contusion or sinusitis (n=7 each; 21.2%); cognitive disorder, tremor, headache, depression, or cough (n=6 each; 18.2%); and urinary tract infection, nausea, diplopia, blurred vision, convulsion, balance disorder, or extremity pain (n=5 each; 15.2%).

“In this small subset of elderly patients, lacosamide appears to be well tolerated and efficacious. Lacosamide could be of potential benefit to the elderly in general as well as for those patients in long-term care facilities,” noted Rosenfeld. —Christina T. Loguidice

The three OLE studies and this analysis were supported by UCB Pharma.