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.

Details

Title
Commentary on 2022 guidelines on clinical trial design in cluster headache and further suggestions
Author
Medrea, Ioana 1 ; Tepper, Stewart J. 2 ; Wang, Donliang 1 ; Mathew, Paul G. 3 ; Burish, Mark 4 

 SUNY Upstate Medical University, New York, USA (GRID:grid.411023.5) (ISNI:0000 0000 9159 4457) 
 The New England Institute for Neurology and Headache, Stamford, USA (GRID:grid.479692.7) 
 Harvard Medical School, Boston, USA (GRID:grid.38142.3c) (ISNI:000000041936754X); Mass General Brigham Health, Department of Neurology, Foxboro, USA (GRID:grid.32224.35) (ISNI:0000 0004 0386 9924); Atrius Health, Department of Neurology, Quincy, USA (GRID:grid.32224.35) 
 UTHealth Houston, Department of Neurosurgery, Houston, USA (GRID:grid.32224.35) 
Pages
32
Publication year
2024
Publication date
Dec 2024
Publisher
Springer Nature B.V.
ISSN
11292369
e-ISSN
11292377
Source type
Scholarly Journal
Language of publication
English
ProQuest document ID
2940955272
Copyright
© The Author(s) 2024. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.