cerbomed Reports Positive Intermediate Results
from Epilepsy Pilot Study
June 08, 2010 09:13 AM Eastern Daylight Time
ERLANGEN, Germany--(EON: Enhanced Online News)--An evaluation has revealed positive intermediate
results for the first three months of data from the clinical trials for the treatment of therapy resistant
epilepsies with the world’s first device using transcutaneous vagus nerve stimulation (t-VNS®), from
cerbomed gmbh. t-VNS® proves its good safety profile and scores high on user -friendliness, and there are
also preliminary indications of its effectiveness, for the patients in the cMPsE01 pilot study.
The cMPsE01 pilot study is structured as an uncontrolled, single-centre prospective pilot study with a verum group,
carried out under the supervision of Professor Dr. Hermann Stefan, at the epilepsy centre of the University Hospital
of Erlangen. The study includes 10 patients, for an expected therapy period of 9 months.
The primary aim of the clinical trial is to prove the safety and feasibility, as well as the compliance of transcutaneous
vagus nerve stimulation (t-VNS®). The study’s secondary aim is the early determination of whether t-VNS® has
anticonvulsive effectiveness, that is, whether it reduces the frequency and duration of episodes in hard-to-treat
epilepsies. A further goal is to gather information for planning the number of cases, as well as specific inclusion and
exclusion criteria for the planned follow-up study, which will focus on the effectiveness of t-VNS® therapy.
The leader of the clinical trial, Professor Dr. Stefan, explains: "The enormous need for effective alternative forms of
therapy for therapy resistant epilepsies was the stimulus to start clinically testing cerbomed’s promising t-VNS®
technology. We are pleased the intermediate results of the clinical trial have turned out to be so positive, and that
they prove the safety and feasibility of t-VNS®. Also, we have seen the first indicators of the possible effectiveness
of the new therapy, whic