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.
Phase:
Phase 3
Details
Lead Sponsor:
Leiden University Medical Center
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development