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Repeated GON Injections in CCH

Study acronym: REGON
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
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.

Record History

  1. Primary completion date: Dec 2024 to Dec 2025 Completion date: Dec 2024 to Jun 2026v3 Show 1 more changeShow less
    • Completion date: Dec 2024 to Jun 2026
  2. Trial status: Not Yet Recruiting to Recruiting Primary completion date: Mar 2024 to Dec 2024 · Start date changed from estimate of Jul 2022 to Nov 7, 2022 · Study sites: 0 to 2 · 2 morev2 Show 5 more changesShow less
    • Primary completion date: Mar 2024 to Dec 2024
    • Start date changed from estimate of Jul 2022 to Nov 7, 2022
    • Study sites: 0 to 2
    • Completion date: Jun 2024 to Dec 2024
    • Eligibility criteria revised

    See this version in full on ClinicalTrials.gov ↗

  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
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
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov