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

Study acronym: RECLAIM-II
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoints added 0 → 2 primary endpoints
See other at-risk trials from Salvia BioElectronics

Record History

  1. Study sites: 2 to 3v6
  2. Study sites: 1 to 2v5
  3. Primary endpoint(s) modified Phase changed: not specified → not applicable · Sponsor changed: [Redacted] to Salvia BioElectronics · Trial status changed: Withheld → Recruiting · 6 morev4 Show 9 more changesShow less
    • Phase changed: not specified → not applicable
    • Sponsor changed: [Redacted] to Salvia BioElectronics
    • Trial status changed: Withheld → Recruiting
    • Enrollment changed: None → 150
    • Trial arms changed: 0 → 2
    • Primary completion date: Oct 1, 2028
    • Completion date: May 1, 2031
    • Start date: Dec 1, 2026
    • Study title expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  4. 2 versions Re-verified since Jul 21, 2026, no change to tracked fieldsv2-v3
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07719608
Lead Sponsor Salvia BioElectronics
Conditions Resistant Migraine, Chronic Migraine Headache, Headache (Migraine), Headache, Cluster
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov