Commentary on 2022 Guidelines on Clinical Trial Design in Cluster Headache and Further Suggestions

Authors

Ioana Medrea
Stewart J Tepper
Donliang Wang
Paul G Mathew
Mark Burish

Publication Date

3-7-2024

Journal

The Journal of Headache and Pain

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

Humans, Clinical Trials as Topic, Cluster Headache, Equivalence Trials as Topic

Comments

PMID: 38454380