Repeated GON injections for chronic cluster headache relief

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of repeated greater occipital nerve (GON) injections as a prophylactic treatment for chronic cluster headache. It is a bi-centre, randomized, double-blind, placebo-controlled trial involving patients diagnosed with chronic cluster headache according to the ICHD-3 criteria. Participants will receive either GON injections with corticosteroids or a placebo, with the primary goal of determining if the injections can reduce the frequency of headache attacks over a one-year follow-up period. The study aims to provide insights into the long-term benefits and safety of this treatment approach.

Why it matters

Who can join: the full rules

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

Where it's running

• Leiden University Medical Center
  Leiden, Netherlands Recruiting
• Canisius Wilhelmina Ziekenhuis
  Nijmegen, Netherlands Recruiting

Study contacts

• Study coordinator: Willemijn Naber
• Email: w.c.naber@lumc.nl
• Phone: 0715262587

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.