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Vimpat (Lacosamide) - Summary

 
 



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.


See all Vimpat indications & dosage >>

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...

more studies >>

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.

more trials >>

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 >>


Page last updated: 2015-08-10

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