Clinical trial NCT04014634: GON-injection for a Sooner and Better Treatment of Cluster Headache
Official title: GON-injection for a Sooner and Better Treatment of Cluster Headache: a Double-blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cluster Headache, Episodic
Greater Occipital Nerve Injection
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
Collaborators: name: Netherlands Brain Foundation
name: Innovatiefonds Zorgverzekeraars
First posted: 2019-07-10
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Patients have to be diagnosed with episodic cluster headache according to the international classification of headache disorders - third edition, ICHD-3
* Patients have to be aged 18-65 years
* Patients need to be newly diagnosed and treatment naïve, or already diagnosed and currently free from prophylactic treatment
* Patients need to have a mean of 1 or more attacks per day in the 3 days preceding inclusion.
* Patients should be in their cluster period for shorter than 4 weeks before inclusion.

Exclusion Criteria:

* A contraindication for treatment with steroids or verapamil
* The use of anticoagulants or known bleeding disorder.
* Use of any prophylactic medication for cluster headache
* Patients with a history of other primary headache who are currently using prophylactic medication for this headache
* Pregnancy

Primary outcomes:
measure: Verapamil mean total dose
timeFrame: 12 week period
Secondary outcomes:
measure: Days to remission
timeFrame: 12 weeks
measure: Daily attacks
timeFrame: 12 weeks
measure: Peak dose verapamil
timeFrame: 12 weeks
measure: Preamature termination
timeFrame: 12 weeks
Other outcomes:
measure: Use of attack medication
timeFrame: 12 weeks
measure: Daily attack severity and duration
timeFrame: For the total study period and each of the three consecutive 4-week time periods
measure: Attack-freedom
timeFrame: days 7, 14 and 28
measure: Non-cluster headache
timeFrame: 12 weeks
measure: Adverse events
timeFrame: 12 weeks
measure: Subjective feeling
timeFrame: Days 7, 14 and 28
measure: Satisfaction score
timeFrame: 12 weeks
measure: Recommendation
timeFrame: Days 7, 14 and 28
measure: Blinding participants
timeFrame: Days 7, 14 and 28
measure: Blinding investigators
timeFrame: Days 7, 14 and 28
Locations:
city: Amsterdam
country: Netherlands
facility: Boerhaave Clinics
state: Noord Holland
city: Leiden
country: Netherlands
facility: LUMC
state: Zuid Holland
city: Leiderdorp
country: Netherlands
facility: Alrijne Ziekenhuis
state: Zuid Holland
city: Blaricum
country: Netherlands
facility: Tergooi Ziekenhuis
city: Heerlen
country: Netherlands
facility: Zuyderland Medisch Centrum
city: Nijmegen
country: Netherlands
facility: Canisius-Wilhelmina Hospital
Study officials:
affiliation: LUMC
name: Rolf Fronczek, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: