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Clinical Trials in Australia / NCT06450444
Recruiting Not applicable

The RECLAIM Study.

NCT06450444 · tracked via the Priya Life Science Australia tracker
Sponsor
Salvia BioElectronics
Phase
Not applicable
Started
2024-06-24
Last updated
2026-08-06

Condition(s) studied

Chronic MigraineHigh Frequency Episodic Migraine

Investigational drug(s) / intervention(s)

PRIMUS

PRIMUS: The Salvia PRIMUS System is designed to provide subcutaneous neurostimulation to the branches of the trigeminal and occipital nerves.

Study summary

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

Sex
ALL
Min age
18 Years
Max age
84 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Safety Evaluation — 12 weeks
    The incidence of serious procedure, device and/or stimulation-related adverse events.
  • Effectiveness Evaluation — 12 weeks
    Proportion of subjects with ≥ 30% reduction in the number of Monthly Migraine Days (MMD), in randomized arms.

Trial sites (11)

FacilityCityRegionStatus
Genesis Research Services Broadmeadow New South Wales Terminated
Resolve Pain Buderim Queensland Terminated
ZAS Antwerpen, Campus Sint-Augustinus Wilrijk Antwerpen Recruiting
Jessa Hasselt Hasselt Limburg Recruiting
Private Practice Dr. Sava Saint-Nicolas Liège Active Not Recruiting
AZ Sint Jan Brugge Bruges West Vlaanderen Recruiting
AZ Groeninge Kortrijk West Vlaanderen Recruiting
AZ Oostende Ostend West Vlaanderen Recruiting
AZ Delta Roeselare West Vlaanderen Recruiting
St. Antonius Nieuwegein Nieuwegein Netherlands Recruiting
Erasmus MC Rotterdam Rotterdam Netherlands Recruiting

More Salvia BioElectronics trials in Australia

REsponse to Combined SONS and ONS in Chronic Cluster headachE Active, not recruiting

Other trials for the same condition

A Study to Evaluate IPN10200 Safety and Efficacy in the Prevention of Episodic or Chronic Migraine in Adults Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06450444 on ClinicalTrials.gov ↗ ← All trials in Australia