VNS RESULTS:

• VNS Study E04: Summary
  • Conducted 1991-95
  • Design: Open Label Study, Non-Randomized, Sequential, Single Blind, 1 Month Baseline
  • Patients: >2 Yrs. Old, All Seizure Types, 1 or more sz/month
    • Patient Participation: 133 Enrolled, 124 Implanted, 123 Treated, 123 Completed, 114 Continuing >1 year
  • Results:
    • 21.4% Median Seizure Reduction after 3 months
    • No Serious Adverse Effects
    • Adverse Effect Profile Similar to Prior Experience
    • Efficacy in other Seizure Types Suggested
  • VNS Study E04: Patients by Seizure Types (N=124)

• VNS Study E04: Common Adverse Events
  • Baseline = 1 Month and Treatment Period = 3 months
    

• VNS Study E04: Overall Efficacy (N=116)
  • -21.8% Median Change in Seizure Frequency (p<0.01)
  • 34/116 (29%) > 50% Reduction in Overall Seizure Frequency
  • Improvement in Overall Well-Being
    • Visual Analogue Scale (+11 to +17; p<0.01) by Investigator, Patient,and Companion
• VNS E04 Study: Conclusions
  • Favorable safety profile
  • No major Cardiac or GI Effects
  • Similar to E03
  • Response rate similar to previous Randomized Controlled Trial (E03)
  • Suggests favorable response in other seizure types and syndromes