Repeated Corticosteroid Injections Around the Greater Occipital Nerve (GON) as Prophylactic Treatment in Chronic Cluster Headache

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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

• On a stable regimen of cluster headache prophylactics for \>4 weeks prior to onset of study treatment and agreeing not to increase the dose and not starting a new cluster prophylactic during the study period

Locations
Other Locations
Netherlands
Leiden University Medical Center
RECRUITING
Leiden
Canisius Wilhelmina Ziekenhuis
RECRUITING
Nijmegen
Contact Information
Primary
Willemijn Naber
w.c.naber@lumc.nl
0715262587
Time Frame
Start Date: 2022-11-07
Estimated Completion Date: 2024-12
Participants
Target number of participants: 50
Treatments
Placebo_comparator: Placebo Arm
Experimental: Intervention Arm
Related Therapeutic Areas
Sponsors
Leads: Leiden University Medical Center
Collaborators: ZonMw: The Netherlands Organisation for Health Research and Development

This content was sourced from clinicaltrials.gov