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dc.contributor.authorDodick, David W
dc.contributor.authorGoadsby, Peter J
dc.contributor.authorAshina, Messoud
dc.contributor.authorTassorelli, Cristina
dc.contributor.authorHundemer, Hans-Peter
dc.contributor.authorBardos, Jennifer N
dc.contributor.authorWenzel Md, Richard
dc.contributor.authorKemmer, Phebe
dc.contributor.authorConley, Robert
dc.contributor.authorMartinez, James M
dc.contributor.authorOakes, Tina
dc.date.accessioned2022-04-14T14:48:30Z
dc.date.available2022-04-14T14:48:30Z
dc.date.issued2022-04-01
dc.identifier.urihttp://hdl.handle.net/10713/18572
dc.description.abstractObjective: 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 either ongoing, not yet recruiting, or the status was unknown. Of the remaining 15 trials, 5 were terminated early and 7 of the 10 completed trials enrolled fewer patients than planned or did not report the planned sample size. A systematic search of PubMed was also utilized to identify published manuscripts reporting results from placebo-controlled preventive trials of CH. This search yielded 16 publications, of which 7 were registered. Through critical review of trial data and published manuscripts, challenges and complexities encountered in clinical trials for the preventive treatment of CH were identified. For example, the excruciating pain associated with CH demands a suitably limited baseline duration, rapid treatment efficacy onset, and poses a specific issue regarding duration of investigational treatment period and length of exposure to placebo. In episodic CH, spontaneous remission as part of natural history, and the unpredictability and irregularity of cluster periods across patients present additional key challenges. Conclusions: Optimal CH trial design should balance sound methodology to demonstrate efficacy of a potential treatment with patient needs and the natural history of the disease, including unique outcome measures and endpoint timings for chronic versus episodic CH. © 2022 Eli Lilly and Company. Headache: The Journal of Head and Face Pain published by Wiley Periodicals LLC on behalf of American Headache Society.en_US
dc.description.urihttps://doi.org/10.1111/head.14292en_US
dc.language.isoenen_US
dc.publisherWiley-Blackwellen_US
dc.relation.ispartofHeadacheen_US
dc.rights© 2022 Eli Lilly and Company. Headache: The Journal of Head and Face Pain published by Wiley Periodicals LLC on behalf of American Headache Society.en_US
dc.subjectchronic cluster headacheen_US
dc.subjectclinical trial designen_US
dc.subjectepisodic cluster headacheen_US
dc.titleChallenges and complexities in designing cluster headache prevention clinical trials: A narrative review.en_US
dc.typeArticleen_US
dc.identifier.doi10.1111/head.14292
dc.identifier.pmid35363381
dc.source.journaltitleHeadache
dc.source.countryUnited States


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