Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
50 participants
INTERVENTIONAL
2022-11-07
2024-12-31
Brief Summary
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\- 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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo Arm
Saline solution
0,9%
Intervention Arm
Methylprednisolone
Injection with prednisolon
Interventions
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Methylprednisolone
Injection with prednisolon
Saline solution
0,9%
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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ZonMw: The Netherlands Organisation for Health Research and Development
OTHER
Leiden University Medical Center
OTHER
Responsible Party
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RolfFronczek
Principal Investigator
Locations
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Leiden University Medical Center
Leiden, , Netherlands
Canisius Wilhelmina Ziekenhuis
Nijmegen, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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Willemijn Naber
Role: primary
Wim Mulleners
Role: primary
Other Identifiers
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79665
Identifier Type: -
Identifier Source: org_study_id