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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
70
Single GON injection with methylprednisolone
Single GON-injection with NaCl
Boerhaave Clinics
Amsterdam, North Holland, Netherlands
LUMC
Leiden, South Holland, Netherlands
Alrijne Ziekenhuis
Leiderdorp, South Holland, Netherlands
Tergooi Ziekenhuis
Blaricum, Netherlands
Zuyderland Medisch Centrum
Heerlen, Netherlands
Canisius-Wilhelmina Hospital
Nijmegen, Netherlands
Verapamil mean total dose
Difference in mean total dose of verapamil used during the study period
Time frame: 12 week period
Days to remission
Median number of days to remission (7 consecutive days without attack)
Time frame: 12 weeks
Daily attacks
Mean number of attacks per day during the study period
Time frame: 12 weeks
Peak dose verapamil
Peak dose verapamil
Time frame: 12 weeks
Preamature termination
Premature termination of study due to need for escape medication
Time frame: 12 weeks
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