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Cluster Headache, EpisodicPhase 4CHIANTINCT04014634

GON-injection for a Sooner and Better Treatment of Cluster Headache

A Phase 4 study testing Methylprednisolone in people with Cluster Headache, Episodic and Greater Occipital Nerve Injection, run by Leiden University Medical Center at 6 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Cluster headache is a very severe primary headache disorder. In episodic cluster headache, attacks occur in 'bouts' (clusters) lasting weeks to months. Management of cluster headache entails a combination of attack and prophylactic treatment. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Methylprednisolone
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
70 participants
Where
6 sitesNetherlands
Study dates
1 Aug 2019to 27 Aug 2021
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients have to be diagnosed with episodic cluster headache according to the international classification of headache disorders - third edition, ICHD-3
  • Patients have to be aged 18-65 years
  • Patients need to be newly diagnosed and treatment naïve, or already diagnosed and currently free from prophylactic treatment
  • Patients need to have a mean of 1 or more attacks per day in the 3 days preceding inclusion.
  • Patients should be in their cluster period for shorter than 4 weeks before inclusion.

Who cannot join

  • A contraindication for treatment with steroids or verapamil
  • The use of anticoagulants or known bleeding disorder.
  • Use of any prophylactic medication for cluster headache
  • Patients with a history of other primary headache who are currently using prophylactic medication for this headache
  • Pregnancy

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Netherlands6 sites

  • Boerhaave Clinics

    Amsterdam, North Holland

  • Tergooi Ziekenhuis

    Blaricum

  • Zuyderland Medisch Centrum

    Heerlen

  • LUMC

    Leiden, South Holland

  • Alrijne Ziekenhuis

    Leiderdorp, South Holland

  • Canisius-Wilhelmina Hospital

    Nijmegen

Other trials in Netherlands

About this study

Official title: GON-injection for a Sooner and Better Treatment of Cluster Headache: a Double-blind Randomized Controlled Trial

Cluster headache is a very severe primary headache disorder. In episodic cluster headache, attacks occur in 'bouts' (clusters) lasting weeks to months. Management of cluster headache entails a combination of attack and prophylactic treatment. Current first choice prophylactic treatment (verapamil) has considerable side effects which can be serious and include possibly fatal cardiac arrhythmias; and it can take weeks to titrate to an effective dose. Evidence has emerged that local steroid injection of the greater occipital nerve (GON) may be effective in cluster headache, but this method has not been investigated as a first line prophylactic treatment in a large, well-documented group of episodic cluster headache patients who are still free of prophylactic medication and just entered a new cluster headache episode. As such, GON-injection has not yet found its way into current treatment protocols. The investigators plan to perform this multicentre double-blind randomized controlled trial to investigate whether GON-injection is efficacious as a first-line prophylactic treatment, aiming to remove the need for high doses of daily medication - such as verapamil - with associated side effects.

Being tested
Methylprednisolone, Placebo
Medical subject headings
Cluster Headache

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MethylprednisoloneDrug

    Single GON injection with methylprednisolone

  • PlaceboOther

    Single GON-injection with NaCl

Study groups in NCT04014634
Study groupRoleWhat they receive
PlaceboPlacebo comparatorInjection of NaCl
Receives: Other: Placebo
VerumExperimentalNot described
Receives: Drug: Methylprednisolone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Verapamil mean total dose

    Difference in mean total dose of verapamil used during the study period

    Measured: 12 week period

Secondary outcomes (4)

  1. Days to remission

    Median number of days to remission (7 consecutive days without attack)

    Measured: 12 weeks

  2. Daily attacks

    Mean number of attacks per day during the study period

    Measured: 12 weeks

  3. Peak dose verapamil

    Peak dose verapamil

    Measured: 12 weeks

  4. Preamature termination

    Premature termination of study due to need for escape medication

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jul 2019
  2. Study start1 Aug 2019
  3. Primary completion27 Aug 2021
  4. Study completion27 Aug 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04014634
Sponsor's protocol ID
NL6719705818
Acronym
CHIANTI
Status last verified
Mar 2024
First submitted
8 Jul 2019
Last updated
13 Mar 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: All Data will be stored using Castor EDC. All hard copies will be stored in the individual centers. If requested, after study completion, data can be shared with de PIs in participating centers.

Publications

  • Brandt RB, Mulleners WM, Couturier E, Carpay JA, Gerlach OHH, Niesters M, Haan J, van Zwet EW, Ferrari MD, Fronczek R. Greater occipital nerve injection with methylprednisolone as transitional therapy in episodic cluster headache: Results from an RCT. Cephalalgia. 2025 Sep;45(9):3331024251370324. doi: 10.1177/03331024251370324. Epub 2025 Sep 24.

    PubMed 40990636

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Methylprednisolone in people with Cluster Headache, Episodic and Greater Occipital Nerve Injection, run by Leiden University Medical Center at 6 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Verapamil mean total dose (time frame: 12 week period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04014634, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2024.

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