NCT04014634

GON-injection for a Sooner and Better Treatment of Cluster Headache

GON-injection for a Sooner and Better Treatment of Cluster Headache: a Double-blind Randomized Controlled Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Leiden University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cluster Headache, Episodic
• Greater Occipital Nerve Injection

Interventions

Type	Name	Description
DRUG	Methylprednisolone	Single GON injection with methylprednisolone
OTHER	Placebo	Single GON-injection with NaCl

Timeline

• Start date: 2019-08-01
• Primary completion: 2021-08-27
• Completion: 2021-08-27
• First posted: 2019-07-10
• Last updated: 2024-03-13

Locations

6 sites across 1 country: Netherlands