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Repeated GON Injections in CCH

RecruitingPhase 3Ages 18 Years - 70 YearsAllLeiden University Medical Center
NCT05324748 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Methylprednisolone
  • Saline solution
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Where

2 sites
Leiden University Medical Center
Leiden, Netherlands
Canisius Wilhelmina Ziekenhuis
Nijmegen, Netherlands
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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