Challenges and complexities in designing cluster headache prevention clinical trials: A narrative review.

ABSTRACT:

Objective

To provide a review of challenges in clinical trials for the preventive treatment of cluster headache (CH) and highlight considerations for future studies.

Background

Current guidelines for preventive treatment of CH are largely based on off-label therapies supported by a limited number of small randomized controlled trials. Guidelines for clinical trial design for CH treatments from the International Headache Society were last issued in 1995.

Methods/results

Randomized controlled clinical trials were identified in the European and/or United States clinical trial registries with a search term of "cluster headache," and manually reviewed. Cumulatively, there were 27 unique placebo-controlled prevention trials for episodic and/or chronic CH, of which 12 were e

SUBMITTER: Dodick DW 

PROVIDER: S-EPMC9325511 | biostudies-literature | 2022 Apr

REPOSITORIES: biostudies-literature