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

Salvia BioElectronics14 sites in 3 countries110 target enrollmentJune 24, 2024

ConditionsChronic Migraine High Frequency Episodic Migraine

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Chronic Migraine
Sponsor: Salvia BioElectronics
Enrollment: 110
Locations: 14
Primary Endpoint: Safety Evaluation
Status: Recruiting
Last Updated: last month

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 24, 2024

End Date

January 31, 2029

Last Updated

last month

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Salvia BioElectronics

Responsible Party

Sponsor

Eligibility Criteria

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