Repeated corticosteroid injections around the Greater Occipital Nerve as treatment in chronic cluster headache

Repeated corticosteroid injections around the Greater Occipital Nerve (GON) as prophylactic treatment in chronic cluster headache - REGON / Repeated GON injections in CCH

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-006687-25-NL

Enrollment

Registered

2022-04-12

Start date

2022-07-21

Completion date

Unknown

Last updated

2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Cluster headache

Interventions

Trade Name: Depo-medro 40mg/ml, suspensie voor injectie Product Name: Methylprednisolonacetaat Pharmaceutical Form: Suspension for injection Pharmaceutical form of the placebo: Solution for injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: - Age =18 - Chronic cluster headache (International Classification of Headache Disorders – third edition; ICHD-3) - Ictal pain must be always at the same side - =8 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 45 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - 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

Design outcomes

Primary

Measure	Time frame
Main Objective: To show that 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. ;Secondary Objective: To determine -If the effect of one GON-injection predict the effects of subsequent GON-injections. -The median GON-injection interval. -The tolerability of repeated GON-injections . -Structural integrity of the GON after the study period.;Primary end point(s): Retention rate (= time between the first injection and end-of-treatment; survival curves verum vs. placebo);Timepoint(s) of evaluation of this end point: After one year follow up (52 weeks)	—

Measure

Time frame

Main Objective: To show that 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. ;Secondary Objective: To determine -If the effect of one GON-injection predict the effects of subsequent GON-injections. -The median GON-injection interval. -The tolerability of repeated GON-injections . -Structural integrity of the GON after the study period.;Primary end point(s): Retention rate (= time between the first injection and end-of-treatment; survival curves verum vs. placebo);Timepoint(s) of evaluation of this end point: After one year follow up (52 weeks)

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Secondary

Measure	Time frame
Secondary end point(s): - Frequency of daily cluster headache attacks - The use of acute attack medication per day (subcutaneous sumatriptan and 100% oxygen) - Mean duration and severity (1-10) of attacks - Injection interval - Total number of injections in study period - Proportion of participants still in study at 1 year - Participants idea: did they receive placebo or verum? - Physician’s idea: did they administer placebo or verum? - Adverse events + ultrasound structural integrity measurements greater occipital nerve - Proportion of subjects with a >50% and 100% reduction in attack frequency - Daily quality of life (EQ 5D) - Healthcare use & productivity losses ;Timepoint(s) of evaluation of this end point: After one year follow up (52 weeks)	—

Measure

Time frame

Secondary end point(s): - Frequency of daily cluster headache attacks - The use of acute attack medication per day (subcutaneous sumatriptan and 100% oxygen) - Mean duration and severity (1-10) of attacks - Injection interval - Total number of injections in study period - Proportion of participants still in study at 1 year - Participants idea: did they receive placebo or verum? - Physician’s idea: did they administer placebo or verum? - Adverse events + ultrasound structural integrity measurements greater occipital nerve - Proportion of subjects with a >50% and 100% reduction in attack frequency - Daily quality of life (EQ 5D) - Healthcare use & productivity losses ;Timepoint(s) of evaluation of this end point: After one year follow up (52 weeks)

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Countries

Netherlands

Contacts

Public ContactHoofdpijnonderzoek

Leiden University Medical Centre

hoofdpijnonderzoek@lumc.nl

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026