Navigation Links
Study: Adding Vimpat significantly reduces partial-onset seizures in adults with epilepsy
Date:1/27/2009

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:

Primary Endpoints

  • The change in seizure frequency per 28 days from baseline to the maintenance period.
  • The 50 percent responder rate, defined as the proportion of patients experiencing a 50 percent or greater reduction in partial seizure frequency per 28 days from the baseline to the maintenance period.

Secondary Endpoints -- Seizure freedom:

  • The number and proportion of patients achieving seizure-free status throughout the maintenance period for patients completing the maintenance period.
  • The proportion of seizure-free days during the maintenance period for patients entering the maintenance period.

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
LFinley@CooneyWaters.com
212-886-2258
Cooney Waters Group, Inc.
Source:Eurekalert

Related medicine news :

1. New study: Short coverage lapses limit childrens access to health care services
2. New Study: Higher DHA Levels Improve Neurodevelopmental Outcomes in Premature Girls
3. UNC study: Access to state childrens health insurance programs vital to disabled children
4. UNC study: Postmenopausal womens loss of sexual desire affects health, quality of life
5. Penn study: Breast cancer survivors call for more survivorship care from primary care physicians
6. Study: Growth in research comes at a steep price
7. First-of-Its Kind Study: Medicare for All (Single-Payer) Reform Would Be Major Stimulus for Economy With 2.6 Million New Jobs, $317 Billion in Business Revenue, $100 Billion in Wages
8. Study: Most young violent offenders in two NYC neighborhoods have seen someone killed
9. Penn study: Chances of surviving cardiac arrest depend on where patients are treated
10. Study: Fluoridation Benefits Doubtful
11. Study: How Can States Treat a Sick Economy? Call the Doctors
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/26/2016)... ... 27, 2016 , ... Quality metrics are proliferating in cancer care, and are ... the eye of the beholder, according to experts who offered insights and commentary in ... Managed Care. For the full issue, click here . , For the American ...
(Date:6/26/2016)... ... June 26, 2016 , ... Many women are confused ... endometriosis. These women need a treatment plan to not only alleviate symptoms and ... help for preservation of fertility and ultimately achieving a pregnancy. The specialists at ...
(Date:6/25/2016)... (PRWEB) , ... June 25, 2016 , ... First ... United States, named Dr. Sesan Ogunleye, as the Medical Director of its new Mesquite-Samuell ... facility Medical Director of our new Mesquite location,” said Dr. James M. Muzzarelli, Executive ...
(Date:6/24/2016)... Angeles, CA (PRWEB) , ... June 24, 2016 , ... ... surgery procedures that most people are unfamiliar with. The article goes on to state ... procedures, but also many of these less common operations such as calf and cheek ...
(Date:6/24/2016)... ... , ... Global law firm Greenberg Traurig, P.A. announced that 20 Florida attorneys ... peers for this recognition are considered among the top 2 percent of lawyers practicing ... members of this year’s Legal Elite Hall of Fame: Miami Shareholders Mark D. ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... 2016  Consumers have taken a more active ... more emphasis on patient outcomes. ... the pharmaceutical industry have evolved beyond just providing ... are focusing on becoming more patient-oriented across their ... services that improve health. ...
(Date:6/24/2016)... June 24, 2016 Research ... "Structural Electronics 2015-2025: Applications, Technologies, Forecasts" ... In-Mold Electronics, Smart Skin, Structural Health ... Structural electronics involves electronic and/or electrical ... structures, replacing dumb structures such as vehicle bodies ...
(Date:6/24/2016)... According to a new market ... Needles, Safety Pen Needles), Needle Length (4mm, 5mm, 6mm, ... of Purchase (Retail, Non-Retail) - Trends & Global Forecasts ... market for the forecast period of 2016 to 2021. ... by 2021 from USD 1.65 Billion in 2016, growing ...
Breaking Medicine Technology: