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A randomised controlled trial of treatment for idiopathic intracranial hypertension

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Abstract

The cause of idiopathic intracranial hypertension (IIH) remains unknown, and no consensus exists on how patients should be monitored and treated. Acetazolamide is a common treatment but has never been examined in a randomised controlled trial. The objectives of this pilot trial are to prospectively evaluate the use of acetazolamide, to explore various outcome measures and to inform the design of a definitive trial in IIH. Fifty patients were recruited from six centres over 23 months and randomised to receive acetazolamide (n = 25) or no acetazolamide (n = 25). Symptoms, body weight, visual function and health-related quality-of-life measures were recorded over a 12-month period. Recruited patients had typical features of mild IIH and most showed improvement, with 44% judged to have IIH in remission at the end of the trial. Difficulties with recruitment were highlighted as well as poor compliance with acetazolamide therapy (12 patients). A composite measure of IIH status was tested, and the strongest concordance with final disease status was seen with perimetry (Somers’ D = 0.66) and optic disc appearance (D = 0.59). Based on the study data, a sample size of 320 would be required to demonstrate a 20% treatment effect in a substantive trial. Clinical trials in IIH require pragmatic design to involve sufficiently large numbers of patients. Future studies should incorporate weighted composite scores to reflect the relative importance of common outcome measures in IIH.

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Authors and Affiliations

  1. Department of Neurology, School of Experimental Medicine, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK

    Alexandra K. Ball & Carl E. Clarke

  2. Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK

    Andrew Howman & Alexandra Furmston

  3. Cancer Research UK Clinical Trials Unit, University of Birmingham, Birmingham, UK

    Keith Wheatley

  4. Birmingham and Midlands Eye Centre, Sandwell and Birmingham NHS Trust, Birmingham, UK

    Michael A. Burdon, Timothy Matthews & Andrew S. Jacks

  5. Department of Neurology, Leicester General Hospital, University Hospitals of Leicester, Leicester, UK

    Mark Lawden

  6. Department of Neurology, City Hospital, Sandwell and West Birmingham Hospitals NHS Trust, Birmingham, UK

    Arul Sivaguru & Carl E. Clarke

  7. Department of Neurology, Royal Hallamshire Hospital, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK

    Steven Howell & Basil Sharrack

  8. Department of Neurology, University Hospital of North Staffordshire NHS Trust, Stoke-on-Trent, UK

    M. Brendan Davies

  9. Academic Unit of Ophthalmology, School of Immunology, Infection and Inflammation, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK

    Alexandra J. Sinclair

  10. North Staffordshire Rehabilitation Centre, University Hospital of North Staffordshire NHS Trust, Haywood Hospital, High Lane, Burslem, Stoke-on-Trent, ST6 7AG, UK

    Alexandra K. Ball

Authors
  1. Alexandra K. Ball
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  2. Andrew Howman
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  3. Keith Wheatley
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  4. Michael A. Burdon
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  5. Timothy Matthews
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  6. Andrew S. Jacks
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  7. Mark Lawden
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  8. Arul Sivaguru
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  9. Alexandra Furmston
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  10. Steven Howell
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  11. Basil Sharrack
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  12. M. Brendan Davies
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  13. Alexandra J. Sinclair
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  14. Carl E. Clarke
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Corresponding author

Correspondence to Alexandra K. Ball.

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Ball, A.K., Howman, A., Wheatley, K. et al. A randomised controlled trial of treatment for idiopathic intracranial hypertension. J Neurol 258, 874–881 (2011). https://doi.org/10.1007/s00415-010-5861-4

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  • DOI: https://doi.org/10.1007/s00415-010-5861-4

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