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Steroid shots may tame cluster headaches for months

NCT ID NCT05324748

Disease control Sponsor: Leiden University Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether repeated injections of a steroid around a nerve in the back of the head can prevent cluster headache attacks in people with chronic cluster headache. Fifty adults with at least four attacks per week will receive either the steroid or a placebo injection every few weeks. The goal is to see if the steroid keeps attacks under control longer than placebo.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Methylprednisolone (steroid injection)
What this could lead to
If successful, this could offer a new, non-daily treatment option to reduce cluster headache attacks for weeks or months at a time.
What could go wrong
This is a small Phase 3 trial with only 50 participants. The benefit may be modest, and steroid injections carry risks like infection or nerve damage.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2022

Expected to finish

Jun 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

cluster headache syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cluster headache

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Canisius Wilhelmina Ziekenhuis

    RECRUITING

    Nijmegen, Netherlands

  • Leiden University Medical Center

    RECRUITING

    Leiden, Netherlands

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