Repeated GON Injections in CCH

Cluster Headache Clinical Trial

— REGON  

Official title:

Repeated Corticosteroid Injections Around the Greater Occipital Nerve (GON) as Prophylactic Treatment in Chronic Cluster Headache

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05324748
• Other study ID #: 79665
• Status: Recruiting
• Phase: Phase 3
• Start date: November 7, 2022
• Est. completion date: December 2024

Study information

• Verified date: December 2023
• Source: Leiden University Medical Center
• Contact: Willemijn Naber
• Phone: 0715262587
• Email: w.c.naber[@]lumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Background:

• The effect of repeated GON-injections has never been studied in a double-blind randomized trial as a prophylactic therapy in a well-documented group of chronic patients. As such, (repeated) GON-injection has not yet found its place in current (inter)national treatment protocols for chronic cluster headache.

Objectives:

• The primary objective is to determine if repeated GON-injection result in effective control of cluster headache attacks for more days compared to placebo in chronic cluster headache.

Eligibility:

• Patients will be selected from the LUMC (Leiden University Medical Center) and CWZ (Canisius Wilhelmina Hospital) chronic cluster headache populations, diagnosed based upon the ICHD-3.

Design:

• Bi-centre, randomized, double-blind, placebo-controlled retention trial with a maximum follow-up of one year.

Description:

A single injection of the greater occipital nerve (GON) with corticosteroids ('GON-injection') has been shown to be efficacious for the prophylactic treatment of cluster headache, with only mild, local side effects and often has its effect within days. It is a low-cost and safe treatment option; however, the beneficial effects are limited to weeks to months. This makes the injection suitable for episodic cluster headache, where periods with headache attacks last weeks to months. However, the effect of repeated GON-injections has never been studied in a double-blind randomized trial as a prophylactic therapy in a well-documented group of chronic patients. As such, (repeated) GON-injection has not yet found its place in current (inter)national treatment protocols for chronic cluster headache. The injection is often only used as a last-resort treatment in a very limited number of headache centres in a trial-and-error approach with a treatment interval varying between 3 and 6 months. It is, therefore, not known what chronic cluster headache patients can expect from this treatment.

Hypothesis: Repeated GON-injections are a safe, well-tolerated, convenient, and cost-effective therapy to rapidly and long-term reduce the attack frequency in chronic cluster headache.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Age =18 and = 70 years

• Chronic cluster headache (International Classification of Headache Disorders - third edition; ICHD-3)

• Ictal pain must be always at the same side

• =4 weekly attacks of cluster headache in the prospective one-month baseline observation period

• On a stable regimen of cluster headache prophylactics for >4 weeks prior to onset of study treatment and agreeing not to increase the dose and not starting a new cluster prophylactic during the study period

Exclusion Criteria:

• Contra-indication against, or current use of, corticosteroids

• Occipital nerve stimulation (ONS)

• Use of anticoagulation medication or a known bleeding disorder

• Inability to use an electronic diary to monitor individual attacks and other items

• Other headaches if the patient cannot reliably distinguish them from attacks of cluster headache

• Current use of prophylactic medication for other headaches

• Pregnancy

Related Conditions & MeSH terms

• Cluster Headache
• Headache

Intervention

Drug:
• Methylprednisolone
Injection with prednisolon
• Saline solution
0,9%

Locations

Country	Name	City	State
Netherlands	Leiden University Medical Center	Leiden
Netherlands	Canisius Wilhelmina Ziekenhuis	Nijmegen

Sponsors (2)

Lead Sponsor	Collaborator
Leiden University Medical Center	ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mean number of days, from first injection until discontinuation, study participants remain using study medication (retention rate in survival curve)		1 year
Secondary	Frequency of weekly cluster headache attacks vs. baseline		1 year
Secondary	Mean duration of attacks vs. baseline		1 year
Secondary	Mean severity (1-10) of attacks vs. baseline		1 year
Secondary	Proportion of study participants with >50% or 100% reduction in attack frequency vs. baseline		1 year
Secondary	Median injection interval		1 year
Secondary	Adverse events		1 year
Secondary	Ultrasound structural integrity of the greater occipital nerve		1 year