A Pivotal Clinical Study to Evaluate the MySalvia System for the Treatment of Resistant Migraine
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-84
SponsorSalvia BioElectronics
About this trial
The purpose of this pivotal clinical study is to evaluate the safety and effectiveness of the MySalvia System, a minimally invasive implantable neuromodulation therapy, for the preventive treatment of adults with resistant migraine.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Documented diagnosis of 1.1 migraine without aura and/or 1.2 migraine with aura and/or 1.3 chronic migraine according to ICHD-3
Leads to considerable impairment in personal, educational and/or occupational areas of functioning (MIDAS rating of severe or very severe)
Concomitant continuous or near continuous headache between migraine attacks
Eight or more monthly migraine days
Disqualifiers
Presence of another chronic primary or secondary headache disorder, unless the participant can reliably differentiate these headaches attacks from migraine attacks, based on the pain characteristics and associated symptoms
Concurrent use of any invasive or non-invasive neuromodulation.
Previous inadequate response to an implantable neuromodulation device for headache or pain management.
Have an existing active implantable medical device nearby the implant location (e.g. DBS, cochlear implant).
Trial design
Design model
Parallel
Treatments tested in this trial
Neurostimulator
DeviceA neurostimulation system that consists of implantable and non-implantable components that work together to deliver mild electrical signals to targeted craniofacial nerves.
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: Active GroupActive comparator 1 intervention
Group B: Active Control GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Primary Endpoint - Efficacy
Proportion of participants achieving a ≥30% reduction in Monthly Migraine Days (MMD) at 24 weeks post device activation compared to baseline.
Time frame
24 weeks2
Primary Outcome Measure - Safety
Incidence of serious procedure-, device- and/or stimulation-related adverse events among all participants at 24 weeks post-device activation.
Time frame
24 WeeksSponsors and contacts
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Source ClinicalTrials.gov