Repeated GON Injections in CCH
Repeated Corticosteroid Injections Around the Greater Occipital Nerve (GON) as Prophylactic Treatment in Chronic Cluster Headache
Leiden University Medical Center
50 participants
Nov 7, 2022
INTERVENTIONAL
Conditions
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, (repeated) GON-injection has not yet found its place in current (inter)national treatment protocols for chronic cluster headache. Objectives: \- The primary objective is to determine if repeated GON-injection result in effective control of cluster headache attacks for more days compared to placebo in chronic cluster headache. Eligibility: \- Patients will be selected from the LUMC (Leiden University Medical Center) and CWZ (Canisius Wilhelmina Hospital) chronic cluster headache populations, diagnosed based upon the ICHD-3. Design: \- Bi-centre, randomized, double-blind, placebo-controlled retention trial with a maximum follow-up of one year.
Eligibility
Inclusion Criteria5
- 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 Criteria7
- 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
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Interventions
Injection with prednisolon
0,9%
Locations(2)
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NCT05324748