Status:
COMPLETED
GON-injection for a Sooner and Better Treatment of Cluster Headache
Lead Sponsor:
Leiden University Medical Center
Collaborating Sponsors:
Netherlands Brain Foundation
Innovatiefonds Zorgverzekeraars
Conditions:
Cluster Headache, Episodic
Greater Occipital Nerve Injection
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
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 combina...
Eligibility Criteria
Inclusion
- Patients have to be diagnosed with episodic cluster headache according to the international classification of headache disorders - third edition, ICHD-3
- Patients have to be aged 18-65 years
- Patients need to be newly diagnosed and treatment naïve, or already diagnosed and currently free from prophylactic treatment
- Patients need to have a mean of 1 or more attacks per day in the 3 days preceding inclusion.
- Patients should be in their cluster period for shorter than 4 weeks before inclusion.
Exclusion
- A contraindication for treatment with steroids or verapamil
- The use of anticoagulants or known bleeding disorder.
- Use of any prophylactic medication for cluster headache
- Patients with a history of other primary headache who are currently using prophylactic medication for this headache
- Pregnancy
Key Trial Info
Start Date :
August 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 27 2021
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04014634
Start Date
August 1 2019
End Date
August 27 2021
Last Update
March 13 2024
Active Locations (6)
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1
Boerhaave Clinics
Amsterdam, North Holland, Netherlands
2
LUMC
Leiden, South Holland, Netherlands
3
Alrijne Ziekenhuis
Leiderdorp, South Holland, Netherlands
4
Tergooi Ziekenhuis
Blaricum, Netherlands