Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06450444

The RECLAIM Study.

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Chronic Migraine High Frequency Episodic Migraine

Age range

18 year–84 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Genesis Research Services, Broadmeadow, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PRIMUS

Device

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

Primary outcomes

  1. Safety Evaluation

    Time frame: 12 weeks

    The incidence of serious procedure, device and/or stimulation-related adverse events.

  2. Effectiveness Evaluation

    Time frame: 12 weeks

    Proportion of subjects with ≥ 30% reduction in the number of Monthly Migraine Days (MMD), in randomized arms.

Sponsors and collaborators

Lead sponsor

Salvia BioElectronics

Industry

Registry information

Official study title

Randomized, Double-blind, Controlled Trial to Investigate Combined Occipital and Supra-orbital Neuromodulation in Resistant Migraine. The RECLAIM Study.

Acronym: RECLAIM

Important dates

Study start
2024
Primary completion
2027
Study completion
2029
First posted
Jun 10, 2024
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.