PMID- 19183227
OWN - NLM
STAT- MEDLINE
DCOM- 20090413
LR  - 20181201
IS  - 1528-1167 (Electronic)
IS  - 0013-9580 (Linking)
VI  - 50
IP  - 3
DP  - 2009 Mar
TI  - Adjunctive lacosamide for partial-onset seizures: Efficacy and safety results 
      from a randomized controlled trial.
PG  - 443-53
LID - 10.1111/j.1528-1167.2008.01951.x [doi]
AB  - PURPOSE: To evaluate the efficacy and safety of lacosamide (200 and 400 mg/day) 
      when added to one to three concomitant antiepileptic drugs (AEDs) in patients 
      with uncontrolled partial-onset seizures. METHODS: This multicenter, 
      double-blind, placebo-controlled trial randomized patients (age 16-70 years) with 
      partial-onset seizures with or without secondary generalization to placebo, 
      lacosamide 200, or lacosamide 400 mg/day. The trial consisted of an 8-week 
      baseline, a 4-week titration, and a 12-week maintenance period. RESULTS: Four 
      hundred eighty-five patients were randomized and received trial medication. Among 
      these, 87% were taking two or more concomitant AEDs. Median percent reduction in 
      seizure frequency per 28 days from baseline to maintenance period 
      (intent-to-treat, ITT) was 20.5% for placebo, 35.3% for lacosamide 200 mg/day (p 
      = 0.02), and 36.4% for 400 mg/day (p = 0.03). In the per protocol population, the 
      reductions were 35.3% for lacosamide 200 mg/day (p = 0.04) and 44.9% for 400 
      mg/day (p = 0.01) compared to placebo (25.4%). The 50% responder rate for 
      lacosamide 400 mg/day (40.5%) was significant (p = 0.01) over placebo (25.8%), 
      but was not for 200 mg/day (35.0%). In the per protocol population, the 50% 
      responder rate for lacosamide 400 mg/day (46.3%) was significant (p < 0.01) 
      compared with the placebo responder rate (27.5%). Dose-related adverse events 
      (AEs) included dizziness, nausea, and vomiting. Clinically relevant changes in 
      the mean plasma concentrations of commonly used AEDs were not observed. 
      DISCUSSION: Results of this trial demonstrated the efficacy and tolerability of 
      adjunctive lacosamide 200 and 400 mg/day and support that lacosamide may be an 
      advantageous option for the treatment of partial-onset seizures in patients with 
      epilepsy.
FAU - Halasz, Peter
AU  - Halasz P
AD  - National Institute of Psychiatry and Neurology, Budapest, Hungary. 
      halasz35@gmail.com
FAU - Kalviainen, Reetta
AU  - Kalviainen R
FAU - Mazurkiewicz-Beldzinska, Maria
AU  - Mazurkiewicz-Beldzinska M
FAU - Rosenow, Felix
AU  - Rosenow F
FAU - Doty, Pamela
AU  - Doty P
FAU - Hebert, David
AU  - Hebert D
FAU - Sullivan, Timothy
AU  - Sullivan T
CN  - SP755 Study Group
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20090117
PL  - United States
TA  - Epilepsia
JT  - Epilepsia
JID - 2983306R
RN  - 0 (Acetamides)
RN  - 0 (Anticonvulsants)
RN  - 563KS2PQY5 (Lacosamide)
SB  - IM
CIN - Epilepsy Curr. 2009 Sep-Oct;9(5):133-4. PMID: 19826503
MH  - Acetamides/adverse effects/pharmacokinetics/*therapeutic use
MH  - Adolescent
MH  - Adult
MH  - Adverse Drug Reaction Reporting Systems
MH  - Anticonvulsants/adverse effects/pharmacokinetics/*therapeutic use
MH  - Biological Availability
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Drug Therapy, Combination
MH  - Epilepsies, Partial/blood/*drug therapy
MH  - Female
MH  - Humans
MH  - Lacosamide
MH  - Male
MH  - Metabolic Clearance Rate/physiology
MH  - Middle Aged
MH  - Young Adult
EDAT- 2009/02/03 09:00
MHDA- 2009/04/14 09:00
CRDT- 2009/02/03 09:00
PHST- 2009/02/03 09:00 [entrez]
PHST- 2009/02/03 09:00 [pubmed]
PHST- 2009/04/14 09:00 [medline]
AID - EPI1951 [pii]
AID - 10.1111/j.1528-1167.2008.01951.x [doi]
PST - ppublish
SO  - Epilepsia. 2009 Mar;50(3):443-53. doi: 10.1111/j.1528-1167.2008.01951.x. Epub 
      2009 Jan 17.