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

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2024年3月7日

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

摘要

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.