Evaluating the PRIMUS System for treating resistant migraines
Official title: Randomized, Double-blind, Controlled Trial to Investigate Combined Occipital and Supra-orbital Neuromodulation in Resistant Migraine. The RECLAIM Study.
Run by Salvia BioElectronics · NCT06450444 · Data updated 2026-11-12
This study tests a new device called the PRIMUS System to see if it can help people with chronic migraines who haven't found relief from other treatments.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 84 Years |
| Sex | All |
| Enrollment | 110 (estimated) |
| Sponsor | Salvia BioElectronics Industry-sponsored |
| Locations | 11 sites (Broadmeadow, New South Wales and 10 other locations) |
| Status | Recruiting |
| Started | June 24, 2024 |
| Main results expected | April 1, 2027 |
| Study ends | January 31, 2029 |
| Registry record updated | August 6, 2026 |
| Trial ID | NCT06450444 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals diagnosed with chronic or high-frequency episodic migraines who have failed multiple preventive treatments.
✕Probably not a fit
Patients currently using other neuromodulation devices or those who have had recent treatments like botulinum toxin injections may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to assess the safety and effectiveness of the PRIMUS System in patients suffering from chronic or high-frequency episodic migraines. Participants must have a history of migraines for at least one year and have failed three or more preventive treatments. The study will involve monitoring the clinical benefits and performance of the device in this specific patient population. The approach focuses on providing a potential new treatment option for those who have not found relief through traditional therapies.
Why it matters
Potential benefit: If successful, this could offer a new treatment option for patients with resistant migraines who have not responded to existing therapies.
How similar studies have gone: While there have been studies on neuromodulation for migraines, the specific use of the PRIMUS System represents a novel approach that has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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. * Use of local corticosteroid injections in the occipital or supra-orbital region in the past 3 months prior to enrollment. * Not pregnant, nursing or not using contraception
Where it's running
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ZAS Antwerpen, Campus Sint-Augustinus
Wilrijk, Antwerpen, Belgium Recruiting -
Jessa Hasselt
Hasselt, Limburg, Belgium Recruiting -
AZ Sint Jan Brugge
Bruges, West Vlaanderen, Belgium Recruiting -
AZ Groeninge
Kortrijk, West Vlaanderen, Belgium Recruiting -
AZ Oostende
Ostend, West Vlaanderen, Belgium Recruiting -
AZ Delta
Roeselare, West Vlaanderen, Belgium Recruiting
Show 5 more locations
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St. Antonius Nieuwegein
Nieuwegein, Netherlands Recruiting -
Erasmus MC Rotterdam
Rotterdam, Netherlands Recruiting -
Genesis Research Services
Broadmeadow, New South Wales, Australia Terminated -
Resolve Pain
Buderim, Queensland, Australia Terminated -
Private Practice Dr. Sava
Saint-Nicolas, Liège, Belgium Active not recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.