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

NCT04014634 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2024-03-13

No results posted yet for this study

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.

Conditions

  • Cluster Headache, Episodic
  • Greater Occipital Nerve Injection

Interventions

DRUG

Methylprednisolone

Single GON injection with methylprednisolone

OTHER

Placebo

Single GON-injection with NaCl

Sponsors & Collaborators

  • Netherlands Brain Foundation

    collaborator OTHER

  • Innovatiefonds Zorgverzekeraars

    collaborator OTHER

  • Leiden University Medical Center

    lead OTHER

Principal Investigators

  • Rolf Fronczek, MD, PhD · LUMC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-01
Primary Completion
2021-08-27
Completion
2021-08-27

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04014634 on ClinicalTrials.gov