Evaluating the PRIMUS System for treating resistant migraines
Randomized, Double-blind, Controlled Trial to Investigate Combined Occipital and Supra-orbital Neuromodulation in Resistant Migraine. The RECLAIM Study.
NA · Salvia BioElectronics · NCT06450444
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 18 Years to 84 Years |
| Sex | All |
| Sponsor | Salvia BioElectronics (industry) |
| Locations | 11 sites (Broadmeadow, New South Wales and 10 other locations) |
| Trial ID | NCT06450444 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with chronic or high-frequency episodic migraines who have failed multiple preventive treatments.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Broadmeadow, New South Wales and 10 other locations
- Genesis Research Services — Broadmeadow, New South Wales, Australia (ACTIVE_NOT_RECRUITING)
- Resolve Pain — Buderim, Queensland, Australia (ACTIVE_NOT_RECRUITING)
- ZAS Antwerpen, Campus Sint-Augustinus — Wilrijk, Antwerpen, Belgium (RECRUITING)
- Jessa Hasselt — Hasselt, Limburg, Belgium (RECRUITING)
- Private Practice Dr. Sava — Saint-Nicolas, Liège, Belgium (ACTIVE_NOT_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)
- St. Antonius Nieuwegein — Nieuwegein, Netherlands (RECRUITING)
- Erasmus MC Rotterdam — Rotterdam, Netherlands (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Chronic Migraine, High Frequency Episodic Migraine