Status:
RECRUITING
Repeated GON Injections in CCH
Lead Sponsor:
Leiden University Medical Center
Collaborating Sponsors:
ZonMw: The Netherlands Organisation for Health Research and Development
Conditions:
Cluster Headache
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
Background: \- The effect of repeated GON-injections has never been studied in a double-blind randomized trial as a prophylactic therapy in a well-documented group of chronic patients. As such, (repe...
Detailed Description
A single injection of the greater occipital nerve (GON) with corticosteroids ('GON-injection') has been shown to be efficacious for the prophylactic treatment of cluster headache, with only mild, loca...
Eligibility Criteria
Inclusion
- Age ≥18 and ≤ 70 years
- Chronic cluster headache (International Classification of Headache Disorders - third edition; ICHD-3)
- Ictal pain must be always at the same side
- ≥4 weekly attacks of cluster headache in the prospective one-month baseline observation period
- On a stable regimen of cluster headache prophylactics for \>4 weeks prior to onset of study treatment and agreeing not to increase the dose and not starting a new cluster prophylactic during the study period
Exclusion
- Contra-indication against, or current use of, corticosteroids
- Occipital nerve stimulation (ONS)
- Use of anticoagulation medication or a known bleeding disorder
- Inability to use an electronic diary to monitor individual attacks and other items
- Other headaches if the patient cannot reliably distinguish them from attacks of cluster headache
- Current use of prophylactic medication for other headaches
- Pregnancy
Key Trial Info
Start Date :
November 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05324748
Start Date
November 7 2022
End Date
June 1 2026
Last Update
November 24 2025
Active Locations (2)
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1
Leiden University Medical Center
Leiden, Netherlands
2
Canisius Wilhelmina Ziekenhuis
Nijmegen, Netherlands