Commentary on 2022 guidelines on clinical trial design in cluster headache and further suggestions

Abstract

Abstract Background New guidelines for cluster headache clinical trials were recently published. We welcome these new guidelines and raise additional considerations in trial methodologies. Main body We present non-inferiority trials to overcome ethical issues with placebo use, and additionally discuss issues with trial recruitment. Conclusions We highlight some possible issues and solutions to be considered with the recently published cluster headache trial guidelines.

Keywords

• Cluster headache trial
• Methodology cluster headache design
• Future directions cluster headache trials