Repeated Corticosteroid Injections Around the Greater Occipital Nerve as Preventive Treatment for Chronic Cluster Headache

What this Trial Is About

Researchers are evaluating repeated injections of the greater occipital nerve (GON) with corticosteroids as a preventive treatment for chronic cluster headache. This study aims to determine if repeated GON injections can control cluster headache attacks for more days compared to a placebo. The trial is a phase 3, double-blind, randomized, placebo-controlled study conducted at two centers, with a maximum follow-up period of one year. The study compares two groups: one receiving injections of methylprednisolone (a corticosteroid) around the greater occipital nerve, and the other receiving placebo injections with saline solution. The injections are given repeatedly to assess their longer-term effects and safety in chronic cluster headache patients. The treatment interval and duration are monitored throughout the one-year study. Participants will be monitored for headache attack frequency, duration, and severity, along with any side effects. They will use electronic diaries to record attacks during baseline and treatment phases. The primary outcome is the number of days participants continue using the study medication over one year. Secondary measures include changes in attack frequency, severity, injection intervals, and nerve integrity through ultrasound. Safety and adverse events are also recorded during the study.

Repeated GON Injections in CCH