RecruitingPhase 3NCT05324748

Repeated GON Injections in CCH

Repeated Corticosteroid Injections Around the Greater Occipital Nerve (GON) as Prophylactic Treatment in Chronic Cluster Headache


Sponsor

Leiden University Medical Center

Enrollment

50 participants

Start Date

Nov 7, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Methylprednisolone and a drug called Saline solution for people with cluster headache. The study is currently recruiting participants at 2 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMethylprednisolone

Injection with prednisolon

DRUGSaline solution

0,9%


Locations(2)

Leiden University Medical Center

Leiden, Netherlands

Canisius Wilhelmina Ziekenhuis

Nijmegen, Netherlands

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NCT05324748


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