An interventional study of PRIMUS in Chronic Migraine and High Frequency Episodic Migraine, sponsored by Salvia BioElectronics. Recruiting at 11 sites in 3 countries. Open to participants aged 18 Years to 84 Years. Per ClinicalTrials.gov, last updated 2026-08-06.
Sponsored by Salvia BioElectronics · Not applicable, Interventional, and Treatment
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.
1,657 studies on the registry are indexed under Migraine Disorders; 339 are open to participants now.
This study's planned enrollment of 110 is above the median of 80 across 1,269 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →Salvia BioElectronics is the lead sponsor of 5 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Active therapy modality
Device: PRIMUS
Sham therapy
Device: PRIMUS
Active therapy modality
Device: PRIMUS
Active therapy modality
Device: PRIMUS
The Salvia PRIMUS System is designed to provide subcutaneous neurostimulation to the branches of the trigeminal and occipital nerves.
Safety Evaluation
The incidence of serious procedure, device and/or stimulation-related adverse events.
Time frame: 12 weeks
Effectiveness Evaluation
Proportion of subjects with ≥ 30% reduction in the number of Monthly Migraine Days (MMD), in randomized arms.
Time frame: 12 weeks
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Salvia BioElectronics