Intravenous lacosamide as replacement for oral lacosamide in patients with partial-onset seizures.
OBJECTIVE
This multicenter, double-blind, double-dummy, randomized, inpatient trial evaluated the safety, tolerability, and pharmacokinetics of intravenous lacosamide as replacement for oral lacosamide in patients with partial-onset seizures.


METHODS
Patients were enrolled from an ongoing open-label extension trial of oral lacosamide and randomized (2:1) to either intravenous lacosamide and oral placebo or intravenous placebo and oral lacosamide. During the 2-day inpatient treatment period, patients received twice-daily doses of lacosamide equivalent to their current daily dose of oral lacosamide. The first 30 patients enrolled received infusions with 60-min durations and the next 30 received infusions with 30-min durations.


RESULTS
Of 60 patients randomized, 59 completed the trial. Treatment-emergent adverse events (AEs) were reported by 16 patients and included dizziness, headache, back pain, somnolence, and injection site pain. The tolerability profile of intravenous lacosamide was consistent with that of oral lacosamide. All AEs were considered mild or moderate in intensity, and no serious AEs or AEs leading to withdrawal were reported.


CONCLUSIONS
Intravenous lacosamide, administered as 60- or 30-min twice-daily infusions, showed a similar safety and tolerability profile to oral lacosamide when used as replacement therapy. Results from this trial support further investigation of intravenous lacosamide at shorter infusion durations.
Biton
Victor
V
Arkansas Epilepsy Program, Little Rock, Arkansas 77025, USA. vbiton@clinicaltrialsinc.com
Rosenfeld
William E
WE
Whitesides
John
J
Fountain
Nathan B
NB
Vaiciene
Nerija
N
Rudd
G David
GD
D000081:Acetamides / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D000284:Administration, Oral; D000328:Adult; D000927:Anticonvulsants / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics; D001416:Back Pain / Q000139:chemically induced; D004244:Dizziness / Q000139:chemically induced; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004828:Epilepsies, Partial / Q000188:drug therapy* / Q000378:metabolism; D005260:Female; D006261:Headache / Q000139:chemically induced; D006801:Humans; D007260:Infusion Pumps; D007262:Infusions, Intravenous; D000078334:Lacosamide; D008297:Male; D008875:Middle Aged; D010919:Placebos; D013997:Time Factors; D016896:Treatment Outcome
D000081:Acetamides; D000927:Anticonvulsants; D010919:Placebos; D000078334:Lacosamide