ATLANTA, April 26, 2012 /PRNewswire/ -- UCB today announced interim results from the VITOBA (VImpaT added to One Baseline AED) study, which showed that patients with less refractory partial-onset seizures treated withVimpat (lacosamide) C-V as add-on to monotherapy experienced seizure reduction. These data were presented today at the 64th annual meeting of the American Academy of Neurology (AAN) in New Orleans.

VITOBA is a six-month prospective, non-interventional study of the efficacy, safety and tolerability of lacosamide when added to a single AED in patients with partial-onset seizures. The study has a planned enrollment of 500 adult patients. This interim analysis included efficacy data for 99 patients and safety data for 109 patients.

The patient population in VITOBA reflects epilepsy patients treated in routine clinical practice. The majority of patients (73.4 percent) had received only 1-3 AEDs since diagnosis. The mean lacosamide maintenance dose was 250mg/day and the median was 200mg/day.

Compared to the overall VITOBA study population, patients treated with only one lifetime AED experienced the greatest benefit from add-on therapy with lacosamide:

Treatment emergent adverse events (TEAEs) included fatigue (11.9 percent), dizziness (10.1 percent) and convulsion (5.5 percent).

"While preliminary, this interim analysis is noteworthy because it reflects a real-world treatment setting and suggests the effect of adding Vimpat as an adjunctive therapy after initial monotherapy. These results need to be confirmed by the final analysis when the study concludes," said Matthias Noack-Rink, lead study author and Medical Affairs Director, Epilepsy, UCB Germany.

Vimpat is indicated as an adjunctive therapy for the treatment of partial-onset seizures in adults with epilepsy. The most common adverse reactions reported in pivotal trials and occurring in 10 percent or more of lacosamide-treated patients, and greater than placebo, were dizziness, headache, nausea and diplopia. Additional important safety information for Vimpat is available at the end of the press release.

About EpilepsyEpilepsy is a chronic neurological disorder affecting approximately 50 million people worldwide and 3 million people in the U.S.Anyone can develop epilepsy; it occurs across all ages, races and genders. Uncontrolled seizures and medication side effects pose challenges to independent living, learning and employment, so the goal of epilepsy treatment is seizure freedom with minimal side effects. More than 1 million patients in the U.S. continue to have seizures despite initial therapy, and more than 800,000 patients in the U.S. continue to have seizures despite treatment with two or more therapies.[1],[2]

About VimpatVimpat tablets and injection were launched in the US in May 2009 as an add-on therapy for the treatment of partial-onset seizures in people with epilepsy who are aged 17 years and older. Vimpat injection is a short-term replacement when oral administration is not feasible in these patients. Vimpat oral solution was launched in June 2010. The availability of the oral tablets, oral solution, and IV injection allows for consistent treatment in a hospital setting. The most common adverse reactions occurring in greater than or equal to 10 percent of Vimpat -treated patients, and greater than placebo, were dizziness, headache, nausea and diplopia. Additional important safety information for Vimpat is available at the end of the press release.

In the European Union, Vimpat (film-coated tablets and solution for infusion) is approved as adjunctive therapy for the treatment of partial-onset seizures with or without secondary generalization in patients with epilepsy, aged 16 years and older. Vimpat solution for infusion may be used when oral administration is temporarily not feasible.

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Interim results of VITOBA™ (VImpaT® added to One Baseline AED) Study Presented at the 64th Annual Meeting of the ...