Phase 3 Study of Botulinum Toxin Type A Injection Targeting the Sphenopalatine Ganglion for Adults with Treatment-Resistant Chronic Cluster Headache

What this Trial Is About

Cluster headache is a condition causing repeated intense one-sided headaches, which can be episodic or chronic. The study evaluates whether a precise injection of botulinum toxin type A targeting the sphenopalatine ganglion SPG, a nerve area involved in pain attacks, can reduce the frequency of attacks in patients with chronic cluster headache. This is a randomized, placebo-controlled, triple-blinded Phase 3 trial to explore this treatment approach further based on earlier promising phase 12 results. Participants receive either a single injection of botulinum toxin type A or a placebo injection, both targeted at the SPG on the headache side of the face, using the Multiguide navigation system for precise delivery. The botulinum toxin dose is 25 Allergan units in 0.5 ml sodium chloride, compared with 0.5 ml sodium chloride alone for the placebo group. The study compares changes in headache attack frequency and intensity during weeks 5 to 8 and weeks 9 to 12 after injection. Throughout the study, participants are monitored for changes in the number and intensity of cluster headache attacks, as well as any adverse events. The primary outcome is the difference in average weekly attacks between weeks 5 and 8 post-injection compared to baseline. Secondary outcomes include safety assessments and responses in predefined subgroups. The study lasts through 12 weeks post-injection, with careful adherence to current headache medications and contraception requirements for women of childbearing potential.

Botulinum Toxin Type A Blockade of the Sphenopalatine Ganglion in Treatment-refractory Chronic Cluster Headache