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

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    Author
    Dodick, David W
    Goadsby, Peter J
    Ashina, Messoud
    Tassorelli, Cristina
    Hundemer, Hans-Peter
    Bardos, Jennifer N
    Wenzel Md, Richard
    Kemmer, Phebe
    Conley, Robert
    Martinez, James M
    Oakes, Tina
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    Date
    2022-04-01
    Journal
    Headache
    Publisher
    Wiley-Blackwell
    Type
    Article
    
    Metadata
    Show full item record
    See at
    https://doi.org/10.1111/head.14292
    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 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.
    Rights/Terms
    © 2022 Eli Lilly and Company. Headache: The Journal of Head and Face Pain published by Wiley Periodicals LLC on behalf of American Headache Society.
    Keyword
    chronic cluster headache
    clinical trial design
    episodic cluster headache
    Identifier to cite or link to this item
    http://hdl.handle.net/10713/18572
    ae974a485f413a2113503eed53cd6c53
    10.1111/head.14292
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