Clinical trial NCT05324748: Repeated GON Injections in CCH
Official title: Repeated Corticosteroid Injections Around the Greater Occipital Nerve (GON) as Prophylactic Treatment in Chronic Cluster Headache
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Cluster Headache
Keywords: GON-injection
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2022-04-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Bi-centre, randomized, double-blind, placebo-controlled retention trial
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: mean number of days, from first injection until discontinuation, study participants remain using study medication (retention rate in survival curve)
timeFrame: 1 year
Secondary outcomes:
measure: Frequency of weekly cluster headache attacks vs. baseline
timeFrame: 1 year
measure: Mean duration of attacks vs. baseline
timeFrame: 1 year
measure: Mean severity (1-10) of attacks vs. baseline
timeFrame: 1 year
measure: Proportion of study participants with >50% or 100% reduction in attack frequency vs. baseline
timeFrame: 1 year
measure: Median injection interval
timeFrame: 1 year
measure: Adverse events
timeFrame: 1 year
measure: Ultrasound structural integrity of the greater occipital nerve
timeFrame: 1 year
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
city: Nijmegen
country: Netherlands
facility: Canisius Wilhelmina Ziekenhuis
Study officials:
References: