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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05324748
Other study ID # 79665
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date November 7, 2022
Est. completion date December 2024

Study information

Verified date December 2023
Source Leiden University Medical Center
Contact Willemijn Naber
Phone 0715262587
Email w.c.naber@lumc.nl
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Background: - The effect of repeated GON-injections has never been studied in a double-blind randomized trial as a prophylactic therapy in a well-documented group of chronic patients. As such, (repeated) GON-injection has not yet found its place in current (inter)national treatment protocols for chronic cluster headache. Objectives: - The primary objective is to determine if repeated GON-injection result in effective control of cluster headache attacks for more days compared to placebo in chronic cluster headache. Eligibility: - Patients will be selected from the LUMC (Leiden University Medical Center) and CWZ (Canisius Wilhelmina Hospital) chronic cluster headache populations, diagnosed based upon the ICHD-3. Design: - Bi-centre, randomized, double-blind, placebo-controlled retention trial with a maximum follow-up of one year.


Description:

A single injection of the greater occipital nerve (GON) with corticosteroids ('GON-injection') has been shown to be efficacious for the prophylactic treatment of cluster headache, with only mild, local side effects and often has its effect within days. It is a low-cost and safe treatment option; however, the beneficial effects are limited to weeks to months. This makes the injection suitable for episodic cluster headache, where periods with headache attacks last weeks to months. However, the effect of repeated GON-injections has never been studied in a double-blind randomized trial as a prophylactic therapy in a well-documented group of chronic patients. As such, (repeated) GON-injection has not yet found its place in current (inter)national treatment protocols for chronic cluster headache. The injection is often only used as a last-resort treatment in a very limited number of headache centres in a trial-and-error approach with a treatment interval varying between 3 and 6 months. It is, therefore, not known what chronic cluster headache patients can expect from this treatment. Hypothesis: 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Methylprednisolone
Injection with prednisolon
Saline solution
0,9%

Locations

Country Name City State
Netherlands Leiden University Medical Center Leiden
Netherlands Canisius Wilhelmina Ziekenhuis Nijmegen

Sponsors (2)

Lead Sponsor Collaborator
Leiden University Medical Center ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary mean number of days, from first injection until discontinuation, study participants remain using study medication (retention rate in survival curve) 1 year
Secondary Frequency of weekly cluster headache attacks vs. baseline 1 year
Secondary Mean duration of attacks vs. baseline 1 year
Secondary Mean severity (1-10) of attacks vs. baseline 1 year
Secondary Proportion of study participants with >50% or 100% reduction in attack frequency vs. baseline 1 year
Secondary Median injection interval 1 year
Secondary Adverse events 1 year
Secondary Ultrasound structural integrity of the greater occipital nerve 1 year
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