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Study on Repeated Corticosteroid Injections with Methylprednisolone Acetate and Sodium Chloride for Patients with Chronic Cluster Headache

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of repeated corticosteroid injections for people suffering from chronic cluster headache. Chronic cluster headache is a severe type of headache that occurs in cyclical patterns or clusters. The treatment being tested involves injections around the Greater Occipital Nerve (GON) to help prevent these headaches. The study uses two types of injections: one with Depo-Medrone, which contains the active substance methylprednisolone acetate, and another with NaCl 0.9% B. Braun, which contains sodium chloride. Some participants will receive a placebo injection.

The purpose of the study is to determine if these injections can safely and effectively reduce the frequency of headache attacks over the long term. Participants will receive injections over a period of time and will be monitored to see how often they experience headaches, how severe the headaches are, and how long they last. The study will also look at the overall quality of life of participants and any side effects they may experience.

Throughout the study, participants will be asked about their experiences and whether they believe they received the actual treatment or a placebo. The study aims to provide valuable information on whether this treatment can be a convenient and cost-effective option for managing chronic cluster headaches.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on criteria such as age (18 or older) and a diagnosis of chronic cluster headache.

    The patient must have experienced at least four weekly attacks of cluster headache during a one-month baseline observation period.

  2. Step 2

    Baseline observation

    A baseline observation period is conducted to monitor the frequency of cluster headache attacks.

    During this time, the patient must maintain a stable regimen of cluster headache prophylactics for more than four weeks prior to the start of the study treatment.

  3. Step 3

    Treatment phase

    The treatment involves repeated injections around the greater occipital nerve.

    Two types of injections are administered: sodium chloride (NaCl 0.9% solution) and methylprednisolone acetate (Depo-Medrone 40 mg/ml suspension).

    These injections are given subcutaneously, which means they are administered under the skin.

  4. Step 4

    Monitoring and evaluation

    The primary goal is to assess the retention rate, which is the time between the first injection and the end of treatment.

    Secondary evaluations include the frequency of daily cluster headache attacks, the use of acute attack medication, and the mean duration and severity of attacks.

    The study also monitors the interval between injections and the total number of injections during the study period.

  5. Step 5

    Quality of life assessment

    The patient's daily quality of life is assessed using a standardized measure known as EQ 5D.

    Healthcare use and productivity losses are also evaluated to understand the broader impact of the treatment.

  6. Step 6

    Completion of study

    The study aims to determine the proportion of participants who remain in the study after one year.

    Participants and physicians are asked to provide their perceptions regarding whether the treatment was a placebo or the actual medication.

    Adverse events and the structural integrity of the greater occipital nerve are monitored using ultrasound.

Who can join the trial?

5 criteria

  • You must be at least 18 years old.
  • You must have a condition called chronic cluster headache, which is defined by a specific set of guidelines known as the International Classification of Headache Disorders, third edition (ICHD-3).
  • The pain from your headaches must always occur on the same side of your head.
  • You need to have at least 4 headache attacks per week during a one-month observation period before the study starts.
  • You should be on a stable treatment plan to prevent cluster headaches for more than 4 weeks before starting the study. You must agree not to increase the dose or start any new preventive treatments during the study.

Who cannot join the trial?

3 criteria

  • Patients who are not experiencing cluster headaches cannot participate. Cluster headaches are severe headaches that occur in patterns or clusters.
  • Patients who are under 18 years old cannot participate.
  • Patients who are part of a vulnerable population, such as those who cannot give consent or are in a dependent relationship, cannot participate.
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Investigated drugs

Corticosteroid Injections are used in this trial as a treatment for chronic cluster headaches. These injections are administered around the Greater Occipital Nerve (GON) to help reduce the frequency of headache attacks. The goal is to provide a safe and effective way to manage and prevent these headaches over the long term.

What is already known about the treatment

Corticosteroid Injections – This medication is administered through injections around the Greater Occipital Nerve. It is currently being studied in clinical trials as a potential treatment for chronic cluster headaches. The main therapeutic indication is to reduce the frequency of headache attacks in individuals suffering from this condition. At the molecular level, corticosteroids work by reducing inflammation and modulating the immune response, which can help alleviate pain and prevent headache episodes. They are classified pharmacologically as anti-inflammatory agents.

Investigated diseases

Cluster Headache – Cluster headache is a neurological disorder characterized by severe, recurring headaches on one side of the head, often around the eye. These headaches occur in cyclical patterns or clusters, which can last for weeks or months, followed by remission periods. The pain is typically intense and can be accompanied by symptoms such as eye redness, tearing, nasal congestion, or a runny nose on the affected side. Attacks often occur at the same time each day and can last from 15 minutes to three hours. The exact cause of cluster headaches is not fully understood, but they are believed to involve abnormalities in the hypothalamus. This condition is more common in men and can significantly impact daily life due to the frequency and severity of the attacks.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-514311-10-00Protocol codeNL79665.058.22Estimated enrolment50 patientsSponsorLeids Universitair Medisch Centrum (LUMC)

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