Health Trials

About this trial

The purpose of this study is to evaluate the safety and performance, including clinical benefit, of the PRIMUS System for the treatment of Resistant Migraine.

Eligibility criteria

Qualifiers

Diagnosis of migraine as defined by the ICHD-3 Classification (with or without aura) with a history of chronic or high-frequency episodic migraine for at least 1 year prior to screening

Failure of 3 or more preventive pharmacological therapies

Stable on preventive migraine treatments

Psychologically stable

Disqualifiers

Concomitant invasive or non-invasive neuromodulation

Previous exposure to an implantable neuromodulation device for headache

Have an existing active implantable medical device nearby the implant location (e.g. DBS, cochlear implant)

Use of onabotulinum toxin A injections for the treatment of migraine in the past 3 months.

Trial design

Treatments tested in this trial

  • PRIMUS

Treatment groups

110 Participants
are divided into 4 treatment groups

Locations

11
Australia
Genesis Research ServicesNSW, 2292, BroadmeadowNew South Wales, Australia
Resolve Pain4556, BuderimQueensland, Australia
Belgium
ZAS Antwerpen, Campus Sint-Augustinus WilrijkAntwerpen, Belgium
Private Practice Dr. Sava Saint-NicolasLiège, Belgium

Sponsors and collaborators

Salvia BioElectronics

Lead sponsor

Source ClinicalTrials.gov