NEWS HIGHLIGHTS
Published Studies Related to Vimpat (Lacosamide)
Lacosamide in painful diabetic neuropathy: an 18-week double-blind placebo-controlled trial. [2009.08]
The efficacy and tolerability of oral lacosamide (200, 400, and 600 mg/day) was evaluated in patients with painful diabetic neuropathy in a double-blind, randomized, placebo-controlled trial. The primary target dose to be confirmed was lacosamide 400 mg/day... Lacosamide treatment at a dose of 400 mg/day reduced diabetic neuropathic pain with a favorable safety and tolerability profile that may be suitable for patients with diabetes.
Efficacy and safety of lacosamide in diabetic neuropathic pain: an 18-week double-blind placebo-controlled trial of fixed-dose regimens. [2009.06]
OBJECTIVES: The aims of this multicenter, randomized, placebo-controlled, double-blind trial were to confirm the efficacy of lacosamide at a daily dose of 400 mg/d and to explore the efficacy, safety, and tolerability of lacosamide 200 mg/d and 600 mg/d in the treatment of painful diabetic neuropathy...
Adjunctive lacosamide for partial-onset seizures: Efficacy and safety results from a randomized controlled trial. [2009.03]
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...
Intravenous lacosamide as replacement for oral lacosamide in patients with partial-onset seizures. [2008.03]
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... 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.
Efficacy and safety of oral lacosamide as adjunctive therapy in adults with partial-onset seizures. [2007.07]
PURPOSE: To evaluate the efficacy and safety of lacosamide when added to 1 or 2 antiepileptic drugs (AEDs) in adults with uncontrolled partial-onset seizures, and assess plasma concentrations of concomitant AEDs to determine any potential for drug interactions... CONCLUSIONS: In this trial, adjunctive lacosamide significantly reduced seizure frequency in patients with uncontrolled partial-onset seizures. Along with favorable pharmacokinetic and tolerability profiles, these results support further development of lacosamide as an AED.
Clinical Trials Related to Vimpat (Lacosamide)
The Safety of Intravenous Lacosamide [Not yet recruiting]
Lacosamide tablets and intravenous formulations were both approved in the United States in
the fall of 2008. Lacosamide is indicated for use as adjunctive therapy in the treatment of
partial onset seizure disorder in patients' age seventeen years and older. A parenteral
dosage form of Lacosamide is desirable for patients who are temporarily unable to take
medication orally. The objective of this study is to evaluate the safety of IV Lacosamide in
children with epilepsy, ages 4 to 20 years, who are either unable to take oral medication,
or whom parenteral administration of IV Lacosamide is desirable.
Trial To Study The Safety And Pharmacokinetics Of Lacosamide In Children With Partial Seizures [Recruiting]
The purpose of this trial is to evaluate the safety and pharmacokinetics of Lacosamide (LCM)
syrup in children ages 2-17 with uncontrolled partial seizures when added to 1 or 2 other
seizure medications.
Trial to Demonstrate the Efficacy and Safety of Conversion to Lacosamide Monotherapy for Partial-onset Seizures [Recruiting]
The objective of this historical-controlled trial is to demonstrate the efficacy and safety
of conversion to lacosamide monotherapy in subjects with partial-onset seizures who are
withdrawn from 1 to 2 marketed antiepileptic drugs.
Post-Authorization Safety Study to Assess the Safety of Vimpat as add-on Therapy in Patients With Partial Onset Seizures [Recruiting]
SP942 is a non-interventional post-authorization safety study (PASS) to evaluate the
long-term safety and tolerability of Vimpat® (lacosamide, LCM) as add-on treatment in
patients with epilepsy 16 years and older with partial-onset seizures who are uncontrolled
on current therapy. Using reported adverse events, the incidence of certain cardiovascular
and psychiatric events will be evaluated.
Trial to Assess Lacosamide as the First add-on Anti-epileptic Drug Treatment in Patients With Partial-onset Seizures [Recruiting]
To evaluate the efficacy and safety of oral lacosamide as first add on treatment in subjects
with uncontrolled partial-onset seizures after prior treatment with a monotherapy
anti-epileptic drug (AED) regimen compared to subjects who have received treatment with at
least 2 anti-epileptic drugs (AEDs).
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