Repeated GON Injections in CCH
Recruiting now · Phase 3 · Has a placebo group
Conditions studied: Cluster Headache
In brief
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.
Key facts
- Study ID
- NCT05324748
- Run by
- Leiden University Medical Center
- People needed
- 50
- Starts
- 2022-11-07
- Expected to finish
- 2026-06-01
- Last updated by the study team
- 2025-11-24
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Leiden University Medical Center — Leiden, Netherlands (enrolling)
- Canisius Wilhelmina Ziekenhuis — Nijmegen, Netherlands (enrolling)
Full record on ClinicalTrials.gov
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