Loading clinical trials...
Loading clinical trials...
GON-injection for a Sooner and Better Treatment of Cluster Headache: a Double-blind Randomized Controlled Trial
Cluster headache is a very severe primary headache disorder. In episodic cluster headache, attacks occur in 'bouts' (clusters) lasting weeks to months. Management of cluster headache entails a combination of attack and prophylactic treatment. Current first choice prophylactic treatment (verapamil) has considerable side effects which can be serious and include possibly fatal cardiac arrhythmias; and it can take weeks to titrate to an effective dose. Evidence has emerged that local steroid injection of the greater occipital nerve (GON) may be effective in cluster headache, but this method has not been investigated as a first line prophylactic treatment in a large, well-documented group of episodic cluster headache patients who are still free of prophylactic medication and just entered a new cluster headache episode. As such, GON-injection has not yet found its way into current treatment protocols. The investigators plan to perform this multicentre double-blind randomized controlled trial to investigate whether GON-injection is efficacious as a first-line prophylactic treatment, aiming to remove the need for high doses of daily medication - such as verapamil - with associated side effects.
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
No
Boerhaave Clinics
Amsterdam, North Holland, Netherlands
LUMC
Leiden, South Holland, Netherlands
Alrijne Ziekenhuis
Leiderdorp, South Holland, Netherlands
Tergooi Ziekenhuis
Blaricum, Netherlands
Zuyderland Medisch Centrum
Heerlen, Netherlands
Canisius-Wilhelmina Hospital
Nijmegen, Netherlands
Start Date
August 1, 2019
Primary Completion Date
August 27, 2021
Completion Date
August 27, 2021
Last Updated
March 13, 2024
70
ACTUAL participants
Methylprednisolone
DRUG
Placebo
OTHER
Lead Sponsor
Leiden University Medical Center
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and Conditions