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REsponse to Combined SONS and ONS in Chronic Cluster headachE

NCT05868044 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2026-04-23

No results posted yet for this study

Summary

The purpose of this study is to demonstrate the safe use of the PRIMUS System in subjects with chronic cluster headache. This is a single-centre, open label, prospective, first in human study to collect initial clinical data on the PRIMUS system for the treatment of chronic cluster headache.

Conditions

  • Chronic Cluster Headache

Interventions

DEVICE

PRIMUS

PRIMUS system

Sponsors & Collaborators

  • Salvia BioElectronics

    lead INDUSTRY

Principal Investigators

  • Paul Frank, MD · Resolve Pain

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-02
Primary Completion
2024-04-23
Completion
2026-12-30

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05868044 on ClinicalTrials.gov