REGON: Repeated GON Injections in CCH

Sponsor

Leiden University Medical Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05324748

Collaborator

ZonMw: The Netherlands Organisation for Health Research and Development (Other)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Cluster Headache	Drug: Methylprednisolone Drug: Saline solution	Phase 3

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Bi-centre, randomized, double-blind, placebo-controlled retention trialBi-centre, randomized, double-blind, placebo-controlled retention trial

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jul 1, 2022

Anticipated Primary Completion Date :

Mar 1, 2024

Anticipated Study Completion Date :

Jun 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Arm	Drug: Saline solution 0,9%
Experimental: Intervention Arm	Drug: Methylprednisolone Injection with prednisolon

Arm

Intervention/Treatment

Placebo Comparator: Placebo Arm

Drug: Saline solution

0,9%

Experimental: Intervention Arm

Drug: Methylprednisolone

Injection with prednisolon

Outcome Measures

Primary Outcome Measures

mean number of days, from first injection until discontinuation, study participants remain using study medication (retention rate in survival curve) [1 year]

Secondary Outcome Measures

Frequency of weekly cluster headache attacks vs. baseline [1 year]
Mean duration of attacks vs. baseline [1 year]
Mean severity (1-10) of attacks vs. baseline [1 year]
Proportion of study participants with >50% or 100% reduction in attack frequency vs. baseline [1 year]
Median injection interval [1 year]
Adverse events [1 year]
Ultrasound structural integrity of the greater occipital nerve [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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
≥8 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