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Partial-onset seizures and pooled analysis (Study background for "Seizure Reduction" and "Concomitant AEDs" site pages)

The effectiveness of Vimpat as adjunctive therapy was established in three 12-week, randomized, multicenter, placebo-controlled, double-blind clinical trials. The pooled analysis of the 3 clinical trials included 1294 adult patients with POS who were not adequately controlled with 1 to 3 concomitant antiepileptic drugs and with or without additional VNS. The primary efficacy variable was change in seizure frequency per 28 days from baseline to maintenance phase. During the 8-week baseline period, patients were required to have a baseline seizure frequency of ≥4 POS per 28 days, with no seizure-free period exceeding 21 days. Following the 8-week baseline period, dosages were titrated to a randomized dose and treatment was maintained for 12 weeks. Trial E1 (Ben-Menachem, N=415) compared dosages of Vimpat at 200 mg/day (100 mg bid), 400 mg/day (200 mg bid), and 600 mg/day* (300 mg bid) with placebo. Trial E2 (Chung, N=402) compared dosages of Vimpat at 400 mg/day (200 mg bid) and 600 mg/day* (300 mg bid) with placebo, and Trial E3 (Halasz, N=477) compared dosages of Vimpat at 200 mg/day (100 mg bid) and 400 mg/day (200 mg bid) with placebo. Patients in all 3 trials initiated active treatment of Vimpat at 100 mg/day (50 mg bid) and the dosage was force titrated in weekly increments of 100 mg/day (50 mg bid) to the randomized target dose over the 6 weeks for Trials E1 and E2, and 4 weeks for Trial E3.

Intent to treat (ITT) includes subjects that received trial medication and had at least 1 post-baseline efficacy assessment. Per Protocol Set (PPS) includes subjects that had at least 1 post-baseline efficacy assessment, had efficacy data collected during the maintenance phase, and did not have a major protocol violation during the trial.

Median percent reduction of seizure frequency—ITT population (Study background for "Seizure Reduction" site page)

In the Chung trial, the median percent reduction of seizure frequency from baseline was 21% with current therapy + placebo (n=104) vs 37% with current therapy + Vimpat 400 mg/day (200 mg bid, n=201), and 38% with current therapy + Vimpat 600 mg/day* (300 mg bid, n=97)
In the Halasz trial, the median percent reduction of seizure frequency from baseline was 21% with current therapy + placebo (n=159) vs 35% with current therapy + Vimpat 200 mg/day (100 mg bid, n=160), and 36% with current therapy + Vimpat 400 mg/day (200 mg bid, n=158)

Long-term efficacy trial (Study background for "Long-term Results" site page)

The Rosenfeld study, a multicenter, open-label extension trial, evaluated the efficacy and safety of long-term exposure to adjunctive Vimpat at doses up to 800 mg/day* (400 mg bid) in 370 adult POS patients previously enrolled in 1 of the primary double-blind trials and 2 open-label trials. Patients from the double-blind trials were transitioned at a starting dose of 200 mg/day (100 mg bid) and starting doses for patients from the open-label trials were based on the dose received from the previous open-label trial. This trial started August 30, 2001, and is ongoing.

* Not an approved dose.

Indication

Vimpat^® (lacosamide) tablets and oral solution are indicated as adjunctive therapy in the treatment of partial-onset seizures in patients with epilepsy who are 17 years and older. Vimpat injection is indicated as short-term replacement when oral administration is not feasible in these patients.

Important Safety Information

Warnings and Precautions

AEDs increase the risk of suicidal behavior and ideation. Patients taking Vimpat should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Patients should be advised that Vimpat may cause dizziness, ataxia, and syncope. Caution is advised for patients with known cardiac conduction problems, who are taking drugs known to induce PR interval prolongation, or with severe cardiac disease. In patients with seizure disorders, Vimpat should be gradually withdrawn to minimize the potential of increased seizure frequency. Multiorgan hypersensitivity reactions have been reported with antiepileptic drugs. If this reaction is suspected, treatment with Vimpat should be discontinued.

Vimpat oral solution contains aspartame, a source of phenylalanine. A 200-mg dose of Vimpat oral solution (equivalent to 20 mL) contains 0.32 mg of phenylalanine.

Common Adverse Reactions

The most common adverse reactions occurring in ≥10 percent of Vimpat-treated patients, and greater than placebo, were dizziness, headache, nausea, and diplopia.

Dosage adjustments are recommended for patients with mild or moderate hepatic impairment or severe renal impairment. Use in severe hepatic impairment patients is not recommended.

Please see Vimpat Prescribing Information.