NCT06450444

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
33mo left

Started Jun 2024

Longer than P75 for not_applicable

Geographic Reach
3 countries

11 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress41%
Jun 2024Jan 2029

First Submitted

Initial submission to the registry

June 4, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 10, 2024

Completed
14 days until next milestone

Study Start

First participant enrolled

June 24, 2024

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2029

Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

2.8 years

First QC Date

June 4, 2024

Last Update Submit

March 26, 2026

Conditions

Chronic MigraineHigh Frequency Episodic Migraine

Outcome Measures

Primary Outcomes (2)

  • Safety Evaluation

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

    12 weeks

  • Effectiveness Evaluation

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

    12 weeks

Study Arms (4)

Cohort 1 - Treatment Group

EXPERIMENTAL

Active therapy modality

Device: PRIMUS

Cohort 1 - Control Group

OTHER

Sham therapy

Device: PRIMUS

Cohort 2 - Therapy V

EXPERIMENTAL

Active therapy modality

Device: PRIMUS

Cohort 2 - Therapy D

EXPERIMENTAL

Active therapy modality

Device: PRIMUS

Interventions

PRIMUSDEVICE

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

Cohort 1 - Control GroupCohort 1 - Treatment GroupCohort 2 - Therapy DCohort 2 - Therapy V

Eligibility Criteria

Age18 Years - 84 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Genesis Research Services

Broadmeadow, New South Wales, NSW, 2292, Australia

ACTIVE NOT RECRUITING

Resolve Pain

Buderim, Queensland, 4556, Australia

ACTIVE NOT RECRUITING

ZAS Antwerpen, Campus Sint-Augustinus

Wilrijk, Antwerpen, Belgium

RECRUITING

Jessa Hasselt

Hasselt, Limburg, 3500, Belgium

RECRUITING

Private Practice Dr. Sava

Saint-Nicolas, Liège, Belgium

ACTIVE NOT RECRUITING

AZ Sint Jan Brugge

Bruges, West Vlaanderen, 8000, 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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2024

First Posted

June 10, 2024

Study Start

June 24, 2024

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

January 31, 2029

Last Updated

March 27, 2026

Record last verified: 2026-03

Locations

NL(2)AU(2)BE(7)