Chronic Cluster HeadacheRESPONSENCT05868044
REsponse to Combined SONS and ONS in Chronic Cluster headachE
A study testing PRIMUS in people with Chronic Cluster Headache, run by Salvia BioElectronics at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Cluster Headache
- What is being tested?
- PRIMUS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteAustralia
- Study dates
- 2 May 2023to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Main Inclusion Criteria:
- Able and willing to provide informed consent
- Documented chronic cluster headache for at least 1 year as per ICHD-3 criteria
- Attack frequency of ≥ 4 attacks per week for ≥ 4 weeks before enrolment
- Documented failure of verapamil (failure meaning ineffective, provoked unacceptable side-effects or contra-indicated)
- Stable on preventive treatment for at least two weeks prior to enrolment.
- Agree to refrain from starting new prophylactic cluster headache medication or other preventive treatments, from 4 weeks before entering the baseline period throughout the duration of the study
- MRI available (not older than 4 years prior to study enrolment) or willing to undergo an MRI to exclude structural lesions potentially causing headache
- Able and willing to complete a headache Diary
Main Exclusion Criteria:
- Any other chronic primary or secondary headache disorder, unless they can clearly differentiate them from cluster headache attacks based on the quality and associated symptoms
- Concomitant neuromodulation, except tVNS
- Previous failure to any implantable neuromodulation device for neurovascular headache
- Have an existing Active Implantable Medical Device nearby the implant location (e.g. DBS, cochlear implant, …)
- Metal implants in the skull (e.g. skull plates, seeds) nearby the implant
- Have a pacemaker or implantable cardioverter defibrillator (ICD)
- Suboccipital infiltrations with steroids and/or local anaesthetics or use of oral steroids in the past 3 months
- Use of botulinum toxin injections in the past 12 weeks
- Calcitonin gene-related peptide inhibitors started less than 12 weeks prior to enrolment
- Women of childbearing age who are pregnant, nursing or not using contraception
Trial locations and contacts
1 site in 1 country.
About this study
Official title: REsponse to Combined SuPra-orbital and Occipital Nerve Stimulation in Chronic Cluster headachE With the PRIMUS System, a First in Human Study
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
- Being tested
- PRIMUS
- Medical subject headings
- Cluster Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRIMUSDevice
PRIMUS system
| Study group | Role | What they receive |
|---|---|---|
| PRIMUS | Experimental | PRIMUS system Receives: Device: PRIMUS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Evaluation
The primary safety assessment is the incidence of serious procedure and/or device-related adverse events in all subjects at 30 days.
Measured: 4 weeks
Safety Evaluation
The primary safety assessment is the incidence of serious procedure and/or device-related adverse events in all subjects at the end of the study.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start2 May 2023
- Primary completion23 Apr 2024
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Cluster HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Salvia BioElectronics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul Frank, MD, Principal investigator, Resolve Pain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05868044
- Sponsor's protocol ID
- SCI-01-CCH
- Acronym
- RESPONSE
- Status last verified
- Apr 2026
- First submitted
- 2 May 2023
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REsponse to Combined SuPra-orbital and Occipital Nerve Stimulation in Chronic Cluster headachE With the PRIMUS System, a First in Human Study
- ClinicalTrials.gov ID
- NCT05868044
- Acronym / sponsor ID
- RESPONSE / SCI-01-CCH
- Conditions
- Chronic Cluster Headache
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Salvia BioElectronicsIndustry (pharma, biotech, devices)
- Study start
- 2 May 2023 (actual)
- Primary completion
- 23 Apr 2024 (actual)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 22 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PRIMUS | Experimental | Device: PRIMUSPRIMUS system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRIMUSPRIMUS system | Device | PRIMUS |
Primary outcome
Safety Evaluation
Time frame: 4 weeks
The primary safety assessment is the incidence of serious procedure and/or device-related adverse events in all subjects at 30 days.
Safety Evaluation
Time frame: 12 months
The primary safety assessment is the incidence of serious procedure and/or device-related adverse events in all subjects at the end of the study.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Frank, MD principal investigator
Resolve Pain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRIMUS in people with Chronic Cluster Headache, run by Salvia BioElectronics at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Evaluation (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.