Actively Recruiting
Repeated GON Injections in CCH
Led by Leiden University Medical Center · Updated on 2025-11-24
50
Participants Needed
2
Research Sites
186 weeks
Total Duration
On this page
Sponsors
L
Leiden University Medical Center
Lead Sponsor
Z
ZonMw: The Netherlands Organisation for Health Research and Development
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Repeated GON Injections in CCH
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 70 years
- Diagnosed with chronic cluster headache according to ICHD-3
- Headache pain always on the same side
- At least 4 cluster headache attacks weekly during one-month baseline observation
- Stable cluster headache preventive treatment for more than 4 weeks before study and agreement not to change it during study
You will not qualify if you...
- Contraindication to corticosteroids or current corticosteroid use
- Occipital nerve stimulation
- Use of blood thinners or known bleeding disorders
- Inability to use an electronic diary for tracking attacks
- Other headaches that cannot be distinguished from cluster headaches
- Current preventive medication for other headaches
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Leiden University Medical Center
Leiden, Netherlands
Actively Recruiting
2
Canisius Wilhelmina Ziekenhuis
Nijmegen, Netherlands
Actively Recruiting
Research Team
W
Willemijn Naber
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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