Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05868044
Other study ID # SCI-01-CCH
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 2, 2023
Est. completion date April 30, 2026

Study information

Verified date May 2024
Source Salvia BioElectronics
Contact Wim Pollet, MD
Phone +32 498 57 98 98
Email wim.pollet@salvianeuro.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 5
Est. completion date April 30, 2026
Est. primary completion date September 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
PRIMUS
PRIMUS system

Locations

Country Name City State
Australia Resolve Pain Buderim Queensland

Sponsors (1)

Lead Sponsor Collaborator
Salvia BioElectronics

Country where clinical trial is conducted

Australia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety Evaluation The primary safety assessment is the incidence of serious procedure and/or device-related adverse events in all subjects at 30 days. 4 weeks
Primary 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. 12 months
See also
  Status Clinical Trial Phase
Completed NCT02462395 - Anodal Transcranial Direct Stimulation (tDCS) for the Treatment of Chronic Cluster Headache Phase 2/Phase 3
Completed NCT05064397 - A 1-year Trial to Inform About Long-term Exposure to Eptinezumab in Participants With Chronic Cluster Headache (cCH) Phase 3
Recruiting NCT01701245 - Prevention and Acute Treatment of Chronic Cluster Headache Compared to Standard of Care Phase 2
Completed NCT01151631 - Occipital Nerve Stimulation in Medically Intractable Chronic Cluster Headache Phase 3
Recruiting NCT06124534 - Bilateral Occipital Nerve Field Stimulation for the Treatment of dtCCH N/A
Unknown status NCT00399243 - Sumatriptan 4 mg Statdose in the Acute Treatment of Cluster Headache Phase 4
Completed NCT01616511 - Pathway CH-1 Long-Term Follow-Up N/A
Completed NCT01359631 - Cephalic Vascular Recording Upon SPG Stimulation N/A
Completed NCT02438826 - A Study of Galcanezumab in Participants With Chronic Cluster Headache Phase 3
Completed NCT02510729 - SPG Neurostimulation in Cluster Patients N/A
Active, not recruiting NCT02168764 - Sphenopalatine Ganglion Stimulation for the Treatment of Chronic Cluster Headache N/A
Completed NCT02797951 - A Study of LY2951742 (Galcanezumab) in Participants With Cluster Headache Phase 3
Not yet recruiting NCT05477459 - LSD to Improve Cluster Headache Impact Trial Phase 2
Completed NCT03244735 - Efficacy of Modified Atkins Ketogenic Diet in Chronic Cluster Headache: a Prospective Case Series N/A
Terminated NCT02964338 - A Study Comparing the Efficacy and Safety of Fremanezumab (TEV-48125) for the Prevention of Chronic Cluster Headache (CCH) Phase 3
Completed NCT01255813 - Sphenopalatine Ganglion Stimulation for the Acute Treatment of Cluster Headache N/A
Active, not recruiting NCT05023460 - Treatment of Chronic Cluster Headache With TENS and ONS N/A