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
About this trial
This is an interventional treatment trial for Cluster Headache focused on measuring GON-injection
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
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
NCT ID
NCT05324748
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
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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