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NCT Number: NCT05324748

Repeated GON Injections in CCH

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.

Recruiting

Interested in participating?

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Leiden University Medical Center, Leiden, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

methylprednisolone

Drug

Injection with prednisolon

Saline Solution

Drug

0,9%

Primary outcomes

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

    Time frame: 1 year

Secondary outcomes

  1. Frequency of weekly cluster headache attacks vs. baseline

    Time frame: 1 year

  2. Mean duration of attacks vs. baseline

    Time frame: 1 year

  3. Mean severity (1-10) of attacks vs. baseline

    Time frame: 1 year

  4. Proportion of study participants with >50% or 100% reduction in attack frequency vs. baseline

    Time frame: 1 year

  5. Median injection interval

    Time frame: 1 year

  6. Adverse events

    Time frame: 1 year

  7. Ultrasound structural integrity of the greater occipital nerve

    Time frame: 1 year

Study contacts

Contact information is provided by the study sponsor or research team.

Willemijn Naber

CONTACT

[email protected]

0715262587

Sponsors and collaborators

Lead sponsor

Leiden University Medical Center

Other

Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

Registry information

Official study title

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

Acronym: REGON

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Apr 12, 2022
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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