GON-injection for a Sooner and Better Treatment of Cluster Headache

Phase 4

Completed

• Conditions: Cluster Headache, Episodic; Greater Occipital Nerve Injection
• Interventions: Other: Placebo; Drug: Methylprednisolone

• Registration Number: NCT04014634
• Lead Sponsor: Leiden University Medical Center

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-08
• Study First Submitted QC: 2019-07-08
• Study First Posted: 2019-07-10
• Study Start: 2019-08-01
• Primary Completion: 2021-08-27
• Study Completion: 2021-08-27
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-12
• Last Update Posted: 2024-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Injection of NaCl
Verum	Methylprednisolone	-

Primary Outcome Measures

Name	Time	Method
Verapamil mean total dose	12 week period	Difference in mean total dose of verapamil used during the study period

Secondary Outcome Measures

Name	Time	Method
Preamature termination	12 weeks	Premature termination of study due to need for escape medication
Peak dose verapamil	12 weeks	Peak dose verapamil
Days to remission	12 weeks	Median number of days to remission (7 consecutive days without attack)
Daily attacks	12 weeks	Mean number of attacks per day during the study period

Trial Locations

Locations (6)

LUMC; 🇳🇱 Leiden, Zuid Holland, Netherlands

Tergooi Ziekenhuis; 🇳🇱 Blaricum, Netherlands

Zuyderland Medisch Centrum; 🇳🇱 Heerlen, Netherlands

Boerhaave Clinics; 🇳🇱 Amsterdam, Noord Holland, Netherlands

Alrijne Ziekenhuis; 🇳🇱 Leiderdorp, Zuid Holland, Netherlands

Canisius-Wilhelmina Hospital; 🇳🇱 Nijmegen, Netherlands