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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06450444
Other study ID # SCI-03-RM
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 24, 2024
Est. completion date February 1, 2027

Study information

Verified date June 2024
Source Salvia BioElectronics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 62
Est. completion date February 1, 2027
Est. primary completion date October 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 84 Years
Eligibility 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 steroid infiltrations or IV administration in the past 3 months. - Not pregnant, nursing or not using contraception

Study Design


Related Conditions & MeSH terms


Intervention

Device:
PRIMUS
The Salvia PRIMUS Peripheral Nerve Stimulation (PNS) System (System) is designed to provide subcutaneous neurostimulation to the branches of the trigeminal and occipital nerves.

Locations

Country Name City State
Belgium AZ Delta Roeselare
Belgium GZA Ziekenhuizen Wilrijk

Sponsors (1)

Lead Sponsor Collaborator
Salvia BioElectronics

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety Evaluation The incidence of serious procedure, device and/or stimulation-related adverse events. 12 weeks
Primary Effectiveness Evaluation Difference between randomization arms, in proportion of subjects with = 30% reduction in the number of Monthly Migraine Days (MMD). 12 weeks
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