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RECRUITING
NCT05324748
PHASE3

Repeated GON Injections in CCH

Sponsor: Leiden University Medical Center

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2022-11-07

Completion Date

2026-06

Last Updated

2025-11-24

Healthy Volunteers

No

Interventions

DRUG

Methylprednisolone

Injection with prednisolon

DRUG

Saline solution

0,9%

Locations (2)

Leiden University Medical Center

Leiden, Netherlands

Canisius Wilhelmina Ziekenhuis

Nijmegen, Netherlands