Repeated GON Injections in CCH

• Status: Not yet recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Leiden University Medical Center
• Collaborator: ZonMw: The Netherlands Organisation for Health Research and Development
• Treatments: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

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

• ≥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

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