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Interim results of VITOBA™ (VImpaT® added to One Baseline AED) Study Presented at the 64th Annual Meeting of the American Academy of Neurology
Date:4/26/2012

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 with Vimpat® (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:

  • 86.7 percent showed a 50 percent or greater reduction in seizure frequency (vs. 77.8 percent of the overall study population)
  • 80 percent showed a more than 75 percent or greater reduction in seizure frequency (vs. 64.6 percent of the overall study population)
  • 66.7 percent of those with a history of one lifetime AED experienced seizure freedom (vs. 43.4 percent of the overall study population)

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-worl
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SOURCE UCB
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