Lacosamide as adjunctive therapy for partial‐onset seizures: A randomized controlled trial

Summary Purpose:  To evaluate the efficacy and safety of lacosamide (400 and 600 mg/day) as adjunctive treatment in patients with uncontrolled partial‐onset seizures taking one to three concomitant antiepileptic drugs (AEDs). Methods:  This multicenter, double‐blind, placebo‐controlled trial randomi...

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Bibliographic Details
Published in:Epilepsia (Copenhagen) 2010-06, Vol.51 (6), p.958-967
Main Authors: Chung, Steve, Sperling, Michael R., Biton, Victor, Krauss, Gregory, Hebert, David, Rudd, G. David, Doty, Pamela
Format: Article
Language:English
Subjects:
Acetamides - administration & dosage
Acetamides - adverse effects
Acetamides - pharmacokinetics
Adolescent
Adult
Aged
Anticonvulsants. Antiepileptics. Antiparkinson agents
Antiepileptic drugs
Biological and medical sciences
Dizziness - chemically induced
Double-Blind Method
Drug Therapy, Combination
Epilepsies, Partial - drug therapy
Epilepsies, Partial - metabolism
Epilepsies, Partial - physiopathology
Epilepsy
Female
Headache. Facial pains. Syncopes. Epilepsia. Intracranial hypertension. Brain oedema. Cerebral palsy
Humans
Lacosamide
Male
Medical sciences
Middle Aged
Nervous system (semeiology, syndromes)
Neurology
Neuropharmacology
Partial‐onset seizures
Pharmacology. Drug treatments
Randomized controlled trial
Seizures - drug therapy
Seizures - metabolism
Seizures - physiopathology
Young Adult
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Summary:Summary Purpose:  To evaluate the efficacy and safety of lacosamide (400 and 600 mg/day) as adjunctive treatment in patients with uncontrolled partial‐onset seizures taking one to three concomitant antiepileptic drugs (AEDs). Methods:  This multicenter, double‐blind, placebo‐controlled trial randomized patients 1:2:1 to placebo, lacosamide 400 mg, or lacosamide 600 mg/day. After an 8‐week baseline period, patients began treatment with placebo or lacosamide 100 mg/day, were force‐titrated weekly (100 mg/day increments) to the target dose, and entered a 12‐week maintenance period. Results:  A total of 405 patients were randomized and received trial medication. Most (82.1%) were taking two to three concomitant AEDs. Median percent reductions in seizure frequency per 28 days from baseline to maintenance (intention‐to‐treat, ITT) were 37.3% for lacosamide 400 mg/day (p = 0.008) and 37.8% for lacosamide 600 mg/day (p = 0.006) compared to 20.8% for placebo, with responder rates of 38.3% and 41.2%, respectively, compared to placebo (18.3%, p 
ISSN:0013-9580
1528-1167
DOI:10.1111/j.1528-1167.2009.02496.x