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Headache: Basic Trial Designs, Sample Sizes and Pitfalls

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Clinical Trials in Neurology

Abstract

In clinical trials in headache research, the primary question — can we get rid of the headache? — seems simple but is complex. There are general issues involved in all clinical trials, and specific issues in headache research affecting trial design, sample size, analysis and interpretation of results. These confounding issues are introduced first. Specific designs, and their potential role in headache trials, are discussed and illustrated next, with reference to the guidelines of the International Headache Society (IHS) on trial design. A discussion on determination of sample size follows. Finally, pitfalls in design, analysis and interpretation are highlighted, with examples.

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Authors
  1. H. Angus-Leppan
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Editors and Affiliations

  1. Neuromuscular Unit, West London Neurosciences Centre, 1st Floor Pilot Wing, Charing Cross Hospital, Fulham Palace Road, W6 8RF, London, UK

    Roberto J. Guiloff MD, FRCP (Consultant Neurologist) (Consultant Neurologist)

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© 2001 Springer-Verlag London

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Angus-Leppan, H. (2001). Headache: Basic Trial Designs, Sample Sizes and Pitfalls. In: Guiloff, R.J. (eds) Clinical Trials in Neurology. Springer, London. https://doi.org/10.1007/978-1-4471-3787-0_23

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  • DOI: https://doi.org/10.1007/978-1-4471-3787-0_23

  • Publisher Name: Springer, London

  • Print ISBN: 978-1-84996-856-0

  • Online ISBN: 978-1-4471-3787-0

  • eBook Packages: Springer Book Archive

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