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NCT Number: NCT04014634

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

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.

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Key information

Conditions

Cluster Headache, Episodic Brain Diseases Central Nervous System Diseases Cluster Headache Greater Occipital Nerve Injection Headache Disorders Headache Disorders, Primary Nervous System Diseases Trigeminal Autonomic Cephalalgias

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Boerhaave Clinics, Amsterdam, North Holland, Netherlands

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

methylprednisolone

Drug

Single GON injection with methylprednisolone

Placebo

Other

Single GON-injection with NaCl

Primary outcomes

  1. Verapamil mean total dose

    Time frame: 12 week period

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

Secondary outcomes

  1. Days to remission

    Time frame: 12 weeks

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

  2. Daily attacks

    Time frame: 12 weeks

    Mean number of attacks per day during the study period

  3. Peak dose verapamil

    Time frame: 12 weeks

    Peak dose verapamil

  4. Preamature termination

    Time frame: 12 weeks

    Premature termination of study due to need for escape medication

Other outcomes

  1. Use of attack medication

    Time frame: 12 weeks

    The total use of attack medication (stratified for oxygen and sumatriptan)

  2. Daily attack severity and duration

    Time frame: For the total study period and each of the three consecutive 4-week time periods

    Mean number, severity (1-10) and duration of attack per day.

  3. Attack-freedom

    Time frame: days 7, 14 and 28

    Percentage of patients that are attack-free at days 7, 14 and 28

  4. Non-cluster headache

    Time frame: 12 weeks

    Occurrence of 'non-cluster' headache (number of days and mean intensity per affected day)

  5. Adverse events

    Time frame: 12 weeks

    Percentage of subjects with adverse-events (stratified for type of side effect (AE, SAE, SUSAR))

  6. Subjective feeling

    Time frame: Days 7, 14 and 28

    Subjective feeling at days 7, 14 and 28 (visual analogue scale, VAS. Scale from 0 to 10 where 0 is worst imaginable and 10 best imaginable)

  7. Satisfaction score

    Time frame: 12 weeks

    Satisfaction score (7 point scale, 0 to 6. 0 is completely unsatisfied and 6 completely satisfied)

  8. Recommendation

    Time frame: Days 7, 14 and 28

    Would the patient recommend this treatment to others

  9. Blinding participants

    Time frame: Days 7, 14 and 28

    What treatment does the patient think he/she received (placebo/GON/uncertain)

  10. Blinding investigators

    Time frame: Days 7, 14 and 28

    What treatment do the investigators think the patient has had

Sponsors and collaborators

Lead sponsor

Leiden University Medical Center

Other

Collaborators

  • Innovatiefonds Zorgverzekeraars
  • Netherlands Brain Foundation

Registry information

Official study title

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

Acronym: CHIANTI

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jul 10, 2019
Registry last updated
Mar 13, 2024

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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