Autonomic Technologies has reported positive preliminary findings from a multi-center Pathway CH-1 study which investigated the safety and efficacy of the company’s experimental neurostimulation system used to treat cluster headache.
The investigational ATI Neurostimulation System is a miniaturized implantable stimulator which is delivered through a surgical incision in the gum, leaving no external scars or cosmetic effects.
In the trial, 22 of approximately 40 planned patients have been recruited in the Pathway CH-1 study. Of those, stimulation data from the therapy ‘titration’ period are available for seven patients.
The primary endpoint of Pain Relief within 15 minutes was met in 67% of headaches treated.
The results of the study demonstrated that 70% of the patients experienced a reduction in the frequency of their headaches by 50% or more as compared to the four-week period prior to study enrollment.
Autonomic Technologies president and CEO Ben Pless said they look forward to continue studies of their technology for cluster headache as well as for migraine.