Atlanta, GA January 27, 2009 press release The new antiepileptic drug Vimpat (lacosamide) demonstrated significantly fewer seizures in adult partial-onset epilepsy patients whose seizures were inadequately controlled despite taking up to three other AEDs, according to a Phase III clinical study published online in Epilepsia.
In the study, seizure reduction was measured by:
Secondary Endpoints -- Seizure freedom:
Vimpat was recently approved by the U.S. Food and Drug Administration (FDA) for use as an add-on therapy for the treatment of partial-onset seizures in adult patients with epilepsy. Earlier this year, the European Commission approved Vimpat for the adjunctive treatment of partial-onset seizures with or without secondary generalization in adult patients with epilepsy.
"These results are particularly encouraging given the number of people with epilepsy who, despite current therapies, still face the challenge of living with uncontrolled seizures," said lead study author Professor Pter Halsz, MD, PhD, National Institute of Psychiatry and Neurology, Neurology Department, Budapest. "Vimpat showed significant efficacy versus placebo in a challenging clinical trial patient population."
In the study, 87 percent of patients were taking at least two AEDs and 37 percent were taking three AEDs. Although they were already taking multiple AEDs, patients enrolled in the trial were still experiencing 9.9 - 11.5 seizures per 28 days at baseline.
Patients who Added Vimpat to Their Treatment Plan Experienced Fewer Seizures
In the double-blind, placebo-controlled Phase III study, patients began experiencing a reduction in seizures during the titration period and maintained or improved seizure control throughout the study. Vimpat significantly reduced seizure frequency per 28 days from baseline versus placebo (20.5 percent for placebo, 35.3 percent for Vimpat 200 mg/day [P=0.02], and 36.4 percent for Vimpat 400 mg/day [P=0.03]).
In addition, a higher rate of patients experienced a 50 percent or greater reduction in seizure frequency. Significantly more patients responded to Vimpat 400 mg/day than placebo (40.5 percent had seizures reduced by at least half versus 25.8 percent, respectively [P=0.01]), and numerically more patients responded to Vimpat 200 mg/day than placebo (35.0 percent had seizures reduced by at least half versus 25.8 percent, respectively [P=0.07]).
Vimpat patients who completed the maintenance phase of the study also experienced more complete seizure freedom than those in the placebo group. Among patients taking Vimpat 200 mg/day and 400 mg/day, 3.6 percent and 2.4 percent, respectively, were seizure-free throughout the maintenance phase, compared to 2.1 percent of patients in the placebo group.
In the study, the most commonly reported treatment-emergent adverse events were dizziness (4.9 percent for placebo, 10.4 percent for Vimpat 200 mg/day and 15.7 percent for Vimpat 400 mg/day), headache (7.4 percent, 11.0 percent and 8.2 percent, respectively) and diplopia (1.2 percent, 8.0 percent and 10.1 percent, respectively). Most adverse events were mild to moderate in intensity. These data are consistent with results from other clinical trials of Vimpat.
About the Study
Researchers in Europe and Australia enrolled 485 patients, aged 16 to 70 years, who had uncontrolled partial-onset seizures, with or without secondary generalizations, for at least two years despite prior therapy with at least two AEDs. The objective of this trial was to evaluate the efficacy and safety of lacosamide doses of 200 mg/day and 400 mg/day. In the study, Vimpat was evaluated in combination with a broad range of both first and second generation AEDs. The five concomitant AEDs taken most frequently by patients in the study were carbamazepine, valproate, lamotrigine, topiramate, and levetiracetam. The mean number of years since diagnosis of epilepsy was 22.3 ( 12.56 years).
During the first eight weeks of the trial, researchers measured baseline seizure frequency rates. Patients were then randomized to receive Vimpat 200 mg/day, Vimpat 400 mg/day or placebo (along with prior AEDs), followed by a four-week forced titration period. Patients were started on either placebo or Vimpat 100 mg/day. Patients in the Vimpat groups were then given increasing doses, in increments of 100 mg/day each week, until reaching the maintenance doses of either 200 mg/day or 400 mg/day. The Vimpat 200 mg/day group received placebo for first 2 weeks to allow all patients to reach the target maintenance dose simultaneously. Patients remained on their final dosing schedule throughout the subsequent 12-week maintenance phase. The efficacy assessment was conducted on an intent-to-treat (ITT) basis that included all randomized patients who had received at least one dose of trial medication and had at least one post-baseline efficacy assessment.
Patients completing the maintenance period were eligible to enter an open-label lacosamide extension trial.
|Contact: Laura Finley|
Cooney Waters Group, Inc.