GON-injection for a Sooner and Better Treatment of Cluster Headache
Status:
Unknown status
Trial end date:
2021-07-01
Target enrollment:
Participant gender:
Summary
Cluster headache is a very severe primary headache disorder. In episodic cluster headache,
attacks occur in 'bouts' (clusters) lasting weeks to months. Management of cluster headache
entails a combination of attack and prophylactic treatment. Current first choice prophylactic
treatment (verapamil) has considerable side effects which can be serious and include possibly
fatal cardiac arrhythmias; and it can take weeks to titrate to an effective dose. Evidence
has emerged that local steroid injection of the greater occipital nerve (GON) may be
effective in cluster headache, but this method has not been investigated as a first line
prophylactic treatment in a large, well-documented group of episodic cluster headache
patients who are still free of prophylactic medication and just entered a new cluster
headache episode. As such, GON-injection has not yet found its way into current treatment
protocols. The investigators plan to perform this multicentre double-blind randomized
controlled trial to investigate whether GON-injection is efficacious as a first-line
prophylactic treatment, aiming to remove the need for high doses of daily medication - such
as verapamil - with associated side effects.
Phase:
Phase 4
Details
Lead Sponsor:
Leiden University Medical Center
Collaborators:
Hersenstichting Innovatiefonds Zorgverzekeraars Netherlands Brain Foundation