Repeated GON Injections in CCH (NCT05324748) | Clinical Trial Compass
RecruitingPhase 3
Repeated GON Injections in CCH
Netherlands50 participantsStarted 2022-11-07
Plain-language 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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
mean number of days, from first injection until discontinuation, study participants remain using study medication (retention rate in survival curve)