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Repeated GON Injections in CCH (REGON)

Primary Purpose

Cluster Headache

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Methylprednisolone
Saline solution
Sponsored by
Leiden University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cluster Headache focused on measuring GON-injection

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Experimental

    Arm Label

    Placebo Arm

    Intervention Arm

    Arm Description

    Outcomes

    Primary Outcome Measures

    mean number of days, from first injection until discontinuation, study participants remain using study medication (retention rate in survival curve)

    Secondary Outcome Measures

    Frequency of weekly cluster headache attacks vs. baseline
    Mean duration of attacks vs. baseline
    Mean severity (1-10) of attacks vs. baseline
    Proportion of study participants with >50% or 100% reduction in attack frequency vs. baseline
    Median injection interval
    Adverse events
    Ultrasound structural integrity of the greater occipital nerve

    Full Information

    First Posted
    April 5, 2022
    Last Updated
    April 5, 2022
    Sponsor
    Leiden University Medical Center
    Collaborators
    ZonMw: The Netherlands Organisation for Health Research and Development
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05324748
    Brief Title
    Repeated GON Injections in CCH
    Acronym
    REGON
    Official Title
    Repeated Corticosteroid Injections Around the Greater Occipital Nerve (GON) as Prophylactic Treatment in Chronic Cluster Headache
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 2022 (Anticipated)
    Primary Completion Date
    March 2024 (Anticipated)
    Study Completion Date
    June 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Leiden University Medical Center
    Collaborators
    ZonMw: The Netherlands Organisation for Health Research and Development

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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.
    Detailed Description
    A single injection of the greater occipital nerve (GON) with corticosteroids ('GON-injection') has been shown to be efficacious for the prophylactic treatment of cluster headache, with only mild, local side effects and often has its effect within days. It is a low-cost and safe treatment option; however, the beneficial effects are limited to weeks to months. This makes the injection suitable for episodic cluster headache, where periods with headache attacks last weeks to months. However, 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. The injection is often only used as a last-resort treatment in a very limited number of headache centres in a trial-and-error approach with a treatment interval varying between 3 and 6 months. It is, therefore, not known what chronic cluster headache patients can expect from this treatment. Hypothesis: Repeated GON-injections are a safe, well-tolerated, convenient, and cost-effective therapy to rapidly and long-term reduce the attack frequency in chronic cluster headache.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cluster Headache
    Keywords
    GON-injection

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Model Description
    Bi-centre, randomized, double-blind, placebo-controlled retention trial
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo Arm
    Arm Type
    Placebo Comparator
    Arm Title
    Intervention Arm
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Methylprednisolone
    Intervention Description
    Injection with prednisolon
    Intervention Type
    Drug
    Intervention Name(s)
    Saline solution
    Intervention Description
    0,9%
    Primary Outcome Measure Information:
    Title
    mean number of days, from first injection until discontinuation, study participants remain using study medication (retention rate in survival curve)
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    Frequency of weekly cluster headache attacks vs. baseline
    Time Frame
    1 year
    Title
    Mean duration of attacks vs. baseline
    Time Frame
    1 year
    Title
    Mean severity (1-10) of attacks vs. baseline
    Time Frame
    1 year
    Title
    Proportion of study participants with >50% or 100% reduction in attack frequency vs. baseline
    Time Frame
    1 year
    Title
    Median injection interval
    Time Frame
    1 year
    Title
    Adverse events
    Time Frame
    1 year
    Title
    Ultrasound structural integrity of the greater occipital nerve
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Willemijn Naber
    Phone
    0715262587
    Email
    w.c.naber@lumc.nl

    12. IPD Sharing Statement

    Learn more about this trial

    Repeated GON Injections in CCH

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