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Response to Combined Trigeminal and Occipital Nerve Stimulation for the Preventive Treatment in Chronic Cluster Headache

Study acronym: SalviaBio
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 60 days later Apr 1, 2027 → May 31, 2027
See other at-risk trials from Salvia BioElectronics

Record History

  1. Primary completion pushed from Apr 1, 2027 to May 31, 2027 Start date: Mar 17, 2026 to Apr 13, 2026v3 Show 1 more changeShow less
    • Start date: Mar 17, 2026 to Apr 13, 2026
  2. Trial status: Not Yet Recruiting to Recruiting Primary completion date: Oct 1, 2026 to Apr 1, 2027 · Start date changed from estimate of Dec 1, 2025 to Mar 17, 2026 · Study sites: 0 to 1 · 1 morev2 Show 4 more changesShow less
    • Primary completion date: Oct 1, 2026 to Apr 1, 2027
    • Start date changed from estimate of Dec 1, 2025 to Mar 17, 2026
    • Study sites: 0 to 1
    • Completion date: Oct 1, 2028 to Dec 1, 2028
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is a limited open-label study being performed at two centers in the Netherlands. All participants will receive the same treatment, and both the patients and doctors will know what that treatment is. The goal is to see how safe and effective the PRIMUS system is for preventing Chronic Cluster Headaches (CCH) in people who haven't responded well to the drug verapamil. The study will also look at the patients' experience using the system.
Trial Details
NCT Number NCT07113470
Lead Sponsor Salvia BioElectronics
Conditions Chronic Cluster Headache
Enrollment 10 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov