Clinical Trial

Repeated GON Injections in CCH

Study acronym: REGON
Recruiting Phase 3
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Record status
This record was last updated November 24, 2025 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2022-04-05; most recent amendment 2025-11-19.
Status change: Not Yet Recruiting → Recruiting 2023-12-19
Trial Details
NCT Number NCT05324748
Lead Sponsor Leiden University Medical Center
Collaborators: ZonMw: The Netherlands Organisation for Health Research and Development
Conditions Cluster Headache
Enrollment 50 participants
Start Date 2022-11-07
Primary Completion 2025-12 (estimated)
Study Completion 2026-06 (estimated)
Updated on ClinicalTrials.gov 2025-11-24