The RECLAIM Study.

Last updated: February 21, 2025
Sponsor: Salvia BioElectronics
Overall Status: Active - Recruiting

Phase

N/A

Condition

Oral Facial Pain

Migraine And Cluster Headaches

Migraine (Pediatric)

Treatment

PRIMUS

Clinical Study ID

NCT06450444
SCI-03-RM
  • Ages 18-84
  • All Genders

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 Criteria

Inclusion

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 yearprior to screening

  • Failure of 3 or more preventive pharmacological therapies

  • Stable on preventive migraine treatments

  • Psychologically stable

Exclusion

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 3months.

  • Use of steroid infiltrations or IV administration in the past 3 months.

  • Not pregnant, nursing or not using contraception

Study Design

Total Participants: 62
Treatment Group(s): 1
Primary Treatment: PRIMUS
Phase:
Study Start date:
June 24, 2024
Estimated Completion Date:
February 01, 2027

Connect with a study center

  • Genesis Research Services

    Broadmeadow, New South Wales NSW, 2292
    Australia

    Active - Recruiting

  • Resolve Pain

    Buderim, Queensland 4556
    Australia

    Active - Recruiting

  • Monash House Private Hospital

    Clayton, Victoria VIC, 3168
    Australia

    Site Not Available

  • Jessa Hasselt

    Hasselt, Limburg 3500
    Belgium

    Active - Recruiting

  • AZ Sint Jan Brugge

    Brugge, West Vlaanderen 8000
    Belgium

    Active - Recruiting

  • AZ Delta

    Roeselare,
    Belgium

    Active - Recruiting

  • GZA Ziekenhuizen

    Wilrijk,
    Belgium

    Site Not Available

  • ZAS Antwerpen, Campus Sint-Augustinus

    Wilrijk,
    Belgium

    Active - Recruiting

  • St. Antonius Nieuwegein

    Nieuwegein,
    Netherlands

    Active - Recruiting

  • Erasmus MC Rotterdam

    Rotterdam,
    Netherlands

    Active - Recruiting

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