PMID- 17888078
OWN - NLM
STAT- MEDLINE
DCOM- 20080611
LR  - 20181201
IS  - 0013-9580 (Print)
IS  - 0013-9580 (Linking)
VI  - 49
IP  - 3
DP  - 2008 Mar
TI  - Intravenous lacosamide as replacement for oral lacosamide in patients with 
      partial-onset seizures.
PG  - 418-24
AB  - PURPOSE: 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.
FAU - Biton, Victor
AU  - Biton V
AD  - Arkansas Epilepsy Program, Little Rock, Arkansas 77025, USA. 
      vbiton@clinicaltrialsinc.com
FAU - Rosenfeld, William E
AU  - Rosenfeld WE
FAU - Whitesides, John
AU  - Whitesides J
FAU - Fountain, Nathan B
AU  - Fountain NB
FAU - Vaiciene, Nerija
AU  - Vaiciene N
FAU - Rudd, G David
AU  - Rudd GD
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20070919
PL  - United States
TA  - Epilepsia
JT  - Epilepsia
JID - 2983306R
RN  - 0 (Acetamides)
RN  - 0 (Anticonvulsants)
RN  - 0 (Placebos)
RN  - 563KS2PQY5 (Lacosamide)
SB  - IM
MH  - Acetamides/*administration & dosage/adverse effects/pharmacokinetics
MH  - Administration, Oral
MH  - Adult
MH  - Anticonvulsants/administration & dosage/adverse effects/pharmacokinetics
MH  - Back Pain/chemically induced
MH  - Dizziness/chemically induced
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Epilepsies, Partial/*drug therapy/metabolism
MH  - Female
MH  - Headache/chemically induced
MH  - Humans
MH  - Infusion Pumps
MH  - Infusions, Intravenous
MH  - Lacosamide
MH  - Male
MH  - Middle Aged
MH  - Placebos
MH  - Time Factors
MH  - Treatment Outcome
EDAT- 2007/09/25 09:00
MHDA- 2008/06/12 09:00
CRDT- 2007/09/25 09:00
PHST- 2007/09/25 09:00 [pubmed]
PHST- 2008/06/12 09:00 [medline]
PHST- 2007/09/25 09:00 [entrez]
AID - EPI1317 [pii]
AID - 10.1111/j.1528-1167.2007.01317.x [doi]
PST - ppublish
SO  - Epilepsia. 2008 Mar;49(3):418-24. doi: 10.1111/j.1528-1167.2007.01317.x. Epub 
      2007 Sep 19.