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

Cluster Headache, Episodic Clinical Trial

— CHIANTI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04014634
• Other study ID #: NL6719705818
• Status: Completed
• Phase: Phase 4
• Start date: August 1, 2019
• Est. completion date: August 27, 2021

Study information

• Verified date: March 2024
• Source: Leiden University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: August 27, 2021
• Est. primary completion date: August 27, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cluster Headache
• Cluster Headache, Episodic
• Greater Occipital Nerve Injection
• Headache

Intervention

Drug:
• Methylprednisolone
Single GON injection with methylprednisolone

Other:
• Placebo
Single GON-injection with NaCl

Locations

Country	Name	City	State
Netherlands	Boerhaave Clinics	Amsterdam	Noord Holland
Netherlands	Tergooi Ziekenhuis	Blaricum
Netherlands	Zuyderland Medisch Centrum	Heerlen
Netherlands	LUMC	Leiden	Zuid Holland
Netherlands	Alrijne Ziekenhuis	Leiderdorp	Zuid Holland
Netherlands	Canisius-Wilhelmina Hospital	Nijmegen

Sponsors (3)

Lead Sponsor	Collaborator
Leiden University Medical Center	Innovatiefonds Zorgverzekeraars, Netherlands Brain Foundation

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Use of attack medication	The total use of attack medication (stratified for oxygen and sumatriptan)	12 weeks
Other	Daily attack severity and duration	Mean number, severity (1-10) and duration of attack per day.	For the total study period and each of the three consecutive 4-week time periods
Other	Attack-freedom	Percentage of patients that are attack-free at days 7, 14 and 28	days 7, 14 and 28
Other	Non-cluster headache	Occurrence of 'non-cluster' headache (number of days and mean intensity per affected day)	12 weeks
Other	Adverse events	Percentage of subjects with adverse-events (stratified for type of side effect (AE, SAE, SUSAR))	12 weeks
Other	Subjective feeling	Subjective feeling at days 7, 14 and 28 (visual analogue scale, VAS. Scale from 0 to 10 where 0 is worst imaginable and 10 best imaginable)	Days 7, 14 and 28
Other	Satisfaction score	Satisfaction score (7 point scale, 0 to 6. 0 is completely unsatisfied and 6 completely satisfied)	12 weeks
Other	Recommendation	Would the patient recommend this treatment to others	Days 7, 14 and 28
Other	Blinding participants	What treatment does the patient think he/she received (placebo/GON/uncertain)	Days 7, 14 and 28
Other	Blinding investigators	What treatment do the investigators think the patient has had	Days 7, 14 and 28
Primary	Verapamil mean total dose	Difference in mean total dose of verapamil used during the study period	12 week period
Secondary	Days to remission	Median number of days to remission (7 consecutive days without attack)	12 weeks
Secondary	Daily attacks	Mean number of attacks per day during the study period	12 weeks
Secondary	Peak dose verapamil	Peak dose verapamil	12 weeks
Secondary	Preamature termination	Premature termination of study due to need for escape medication	12 weeks