ABSTRACT
The first patient was treated with VNS in
1988 as part of a pilot, single-blind trial of
patients with refractory partial seizures who
were not candidates for epilepsy surgery.6 The
first pivotal trial of VNS was the E03 study, a
multicenter, double-blind, randomized,
parallel, active-control trial of VNS in 114
patients with predominantly partial
seizures.7-10 The second pivotal clinical study
was the E05 study, a multicenter, double-
blind, randomized, parallel, active-control trial
of VNS in 199 patients with complex partial
seizures.11 In 1991, a compassionate-use trial
enrolled 124 patients with all types of
The study designs, as well as the efficacy
results, of the E03 and the E05 trials will be
discussed in detail. Efficacy for other seizure
types and in childhood epilepsies will then be
presented.
