Repeated GON injections for chronic cluster headache relief
Repeated Corticosteroid Injections Around the Greater Occipital Nerve (GON) as Prophylactic Treatment in Chronic Cluster Headache
This study is testing if repeated injections in the back of the head can help people with chronic cluster headaches have fewer headache attacks.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Leiden University Medical Center Academic / other |
| Locations | 2 sites (Leiden and 1 other locations) |
| Trial ID | NCT05324748 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 70 with a diagnosis of chronic cluster headache experiencing at least four attacks per week.
Not a fit: Patients with contraindications to corticosteroids, those using anticoagulants, or individuals with other headache disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the frequency of cluster headache attacks for patients suffering from this debilitating condition.
How similar studies have performed: While GON injections have shown promise in treating episodic cluster headaches, this specific approach of repeated injections in chronic cases has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Leiden and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.