Repeated GON Injections in CCH

Launched by LEIDEN UNIVERSITY MEDICAL CENTER · Apr 5, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the effects of repeated injections of a treatment called GON (greater occipital nerve) injections for people suffering from chronic cluster headaches. The goal is to see if these injections can help reduce the number of headache days compared to a placebo, which is a treatment that does not have any active ingredients. This trial is important because, until now, no one has thoroughly tested the use of GON injections in a scientific way for this condition.

If you're between 18 and 70 years old and have been diagnosed with chronic cluster headaches, you might be eligible to participate. To qualify, you need to experience at least four headache attacks per week and have been on a stable treatment plan for your headaches for at least four weeks before joining the study. Participants will be randomly assigned to receive either the GON injections or a placebo, and they will keep a diary to track their headaches over a year. This trial is currently recruiting participants, and it offers a chance to contribute to our understanding of potential new treatments for chronic cluster headaches.

Gender

ALL

Eligibility 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