Clinical Trial

A Pivotal Clinical Study to Evaluate the MySalvia System for the Treatment of Resistant Migraine

Study acronym: RECLAIM-II
Recruiting
View on ClinicalTrials.gov →
Summary
The purpose of this pivotal clinical study is to evaluate the safety and effectiveness of the MySalvia System, a minimally invasive implantable neuromodulation therapy, for the preventive treatment of adults with resistant migraine.
Protocol Amendment History 6 changes
critical Trial status changed: Withheld → Recruiting 2026-08-14
critical Phase changed: not specified -> not applicable 2026-08-14
critical Primary endpoint(s) modified 2026-08-14
notable Enrollment changed: None -> 150 2026-08-14
notable Sponsor changed: [Redacted] -> Salvia BioElectronics 2026-08-14
minor Trial arms changed: 0 -> 2 2026-08-14
Trial Details
NCT Number NCT07719608
Lead Sponsor Salvia BioElectronics
Conditions Resistant Migraine, Chronic Migraine Headache, Headache (Migraine), Headache, Cluster
Enrollment 150 participants
Start Date 2026-12-01
Primary Completion 2028-10-01 (estimated)
Study Completion 2031-05-01 (estimated)
Updated on ClinicalTrials.gov 2026-08-13