Repeated GON Injections in CCH
ConditionCluster Headache
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorLeiden University Medical Center
About this trial
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.
Eligibility criteria
Qualifiers
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
≥4 weekly attacks of cluster headache in the prospective one-month baseline observation period
Disqualifiers
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
Trial design
Treatments tested in this trial
- Methylprednisolone
- Saline solution
Treatment groups
50 Participants
are divided into 2 treatment groupsSponsors and collaborators
Leiden University Medical Center
Lead sponsor
ZonMw: The Netherlands Organisation for Health Research and Development
Collaborator
Source ClinicalTrials.gov