VIMPAT SUMMARY
The chemical name of lacosamide, the single (R)-enantiomer, is (R)-2-acetamido-N-benzyl-3-methoxypropionamide (IUPAC). Lacosamide is a functionalized amino acid. VIMPAT injection is a clear, colorless, sterile solution containing 10 mg lacosamide per mL for intravenous infusion. One 20-mL vial contains 200 mg of lacosamide drug substance.
Partial-Onset Seizures
VIMPAT (lacosamide) tablets and oral solution are indicated as adjunctive therapy in the treatment of partial-onset seizures in patients with epilepsy aged 17 years and older.
VIMPAT (lacosamide) injection for intravenous use is indicated as adjunctive therapy in the treatment of partial-onset seizures in patients with epilepsy aged 17 years and older when oral administration is temporarily not feasible.
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NEWS HIGHLIGHTS
Published Studies Related to Vimpat (Lacosamide)
Effect of lacosamide on the steady-state pharmacokinetics of digoxin: results
from a phase I, multiple-dose, double-blind, randomised, placebo-controlled,
crossover trial. [2014]
with lacosamide or placebo... CONCLUSION: Co-administration of steady-state digoxin (0.25 mg/day) with
Lacosamide: a review of its use as adjunctive therapy in the management of
partial-onset seizures. [2013]
Lacosamide (Vimpat(®)) is a functionalized amino acid available orally (as a
syrup or tablet) and as an intravenous infusion. It is believed to exert its
antiepileptic effect by selectively enhancing the slow inactivation of
voltage-gated sodium channels... Thus, oral and intravenous lacosamide as an adjunctive therapy to other
AEDs provides a useful option in the treatment of patients with partial-onset
seizures.
Development of lacosamide for the treatment of partial-onset seizures. [2013]
Lacosamide is an antiepileptic drug (AED) available in multiple formulations that
was first approved in 2008 as adjunctive therapy for partial-onset seizures (POS)
in adults. Unlike traditional sodium channel blockers affecting fast
inactivation, lacosamide selectively enhances sodium channel slow inactivation...
The adverse event profile of lacosamide: a systematic review and meta-analysis of
randomized controlled trials. [2013]
PURPOSE: Defining the tolerability and safety profile of recently marketed
antiepileptic drugs, such as lacosamide (LCM), is a prerequisite for their
optimal utilization in clinical practice. We aimed to identify any adverse event
(AE) associated with LCM treatment by conducting a systematic review and
meta-analysis of all available randomized controlled trials (RCTs).
Lacosamide and epilepsy. [2011.12]
We will review all available studies on the use of lacosamide in the treatment of partial-onset seizures. The available evidence includes two open-label studies and three randomized controlled trials evaluating the safety and efficacy of oral lacosamide...
Clinical Trials Related to Vimpat (Lacosamide)
Three-way-cross-over Study to Evaluate Safety and Pharmacokinetics of Lacosamide in Healthy Japanese and Chinese Males [Completed]
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of
lacosamide following single oral administration of lacosamide 100 mg, 200 mg and 400 mg in
healthy male Chinese and Japanese subjects.
Belgian Drug-utilization Study to Evaluate the Use of VIMPAT� as Adjunctive Treatment of Partial Onset Seizures in Subjects Aged 16 and Older [Completed]
Observational study at the request of the Belgian Institut National d'Assurance
Maladie-Invalidité / Rijksinstituut voor Ziekte-en Invaliditeits Verzekering INAMI/RIZIV:
- type of patient treated with VIMPAT®
- VIMPAT® dose
- Effect of VIMPAT® on evolution of seizure control
- Persistence rate at 6 months in terms of treatment duration
- Discontinuation rate
- Description of any changes in other epilepsy therapies
- Safety and tolerability
Post-Authorization Safety Study to Assess the Safety of Vimpat as add-on Therapy in Patients With Partial-onset Seizures [Completed]
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.
Bioavailability/Bioequivalence Study Between Lacosamide Tablet and Solution for Infusion in Healthy Japanese Subjects [Completed]
This study will be conducted to compare the pharmacokinetics of Lacosamide (LCM) following a
single 30-minute or 60-minute iv infusion of LCM 200 mg with those following a single oral
dose of LCM 200 mg in healthy Japanese subjects.
To Evaluate the Pharmacokinetics and Safety/Tolerability of Lacosamide in 3 Dosages in Healthy Male Korean Subjects [Completed]
Primary objective of this trial was to investigate the pharmacokinetics of single dose and
repeated dose applications of lacosamide in healthy male Korean subjects.
Reports of Suspected Vimpat (Lacosamide) Side Effects
Convulsion (139),
Grand MAL Convulsion (37),
Dizziness (28),
Fatigue (26),
Status Epilepticus (23),
Headache (22),
Death (22),
Fall (21),
Gait Disturbance (21),
Pregnancy (20), more >>
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