caa a22 4500 445810467 CHVBK 20180317145210.0 cr unu---uuuuu 170323e20110501xx s 000 0 eng 10.1007/s00415-010-5861-4 doi (NATIONALLICENCE)springer-10.1007/s00415-010-5861-4 A randomised controlled trial of treatment for idiopathic intracranial hypertension [Elektronische Daten] [Alexandra Ball, Andrew Howman, Keith Wheatley, Michael Burdon, Timothy Matthews, Andrew Jacks, Mark Lawden, Arul Sivaguru, Alexandra Furmston, Steven Howell, Basil Sharrack, M. Davies, Alexandra Sinclair, Carl Clarke] 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 23months 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. Springer-Verlag, 2010 Idiopathic intracranial hypertension nationallicence Randomised controlled clinical trials nationallicence Ball Alexandra Department of Neurology, School of Experimental Medicine, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK aut Howman Andrew Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK aut Wheatley Keith Cancer Research UK Clinical Trials Unit, University of Birmingham, Birmingham, UK aut Burdon Michael Birmingham and Midlands Eye Centre, Sandwell and Birmingham NHS Trust, Birmingham, UK aut Matthews Timothy Birmingham and Midlands Eye Centre, Sandwell and Birmingham NHS Trust, Birmingham, UK aut Jacks Andrew Birmingham and Midlands Eye Centre, Sandwell and Birmingham NHS Trust, Birmingham, UK aut Lawden Mark Department of Neurology, Leicester General Hospital, University Hospitals of Leicester, Leicester, UK aut Sivaguru Arul Department of Neurology, City Hospital, Sandwell and West Birmingham Hospitals NHS Trust, Birmingham, UK aut Furmston Alexandra Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK aut Howell Steven Department of Neurology, Royal Hallamshire Hospital, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK aut Sharrack Basil Department of Neurology, Royal Hallamshire Hospital, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK aut Davies M. Department of Neurology, University Hospital of North Staffordshire NHS Trust, Stoke-on-Trent, UK aut Sinclair Alexandra Academic Unit of Ophthalmology, School of Immunology, Infection and Inflammation, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK aut Clarke Carl Department of Neurology, School of Experimental Medicine, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK aut Journal of Neurology Springer-Verlag 258/5(2011-05-01), 874-881 0340-5354 258:5<874 2011 258 415 https://doi.org/10.1007/s00415-010-5861-4 text/html Onlinezugriff via DOI 1 research-article jats NATIONALLICENCE 856 40 https://doi.org/10.1007/s00415-010-5861-4 text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Ball Alexandra Department of Neurology, School of Experimental Medicine, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK aut NATIONALLICENCE 700 1- Howman Andrew Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK aut NATIONALLICENCE 700 1- Wheatley Keith Cancer Research UK Clinical Trials Unit, University of Birmingham, Birmingham, UK aut NATIONALLICENCE 700 1- Burdon Michael Birmingham and Midlands Eye Centre, Sandwell and Birmingham NHS Trust, Birmingham, UK aut NATIONALLICENCE 700 1- Matthews Timothy Birmingham and Midlands Eye Centre, Sandwell and Birmingham NHS Trust, Birmingham, UK aut NATIONALLICENCE 700 1- Jacks Andrew Birmingham and Midlands Eye Centre, Sandwell and Birmingham NHS Trust, Birmingham, UK aut NATIONALLICENCE 700 1- Lawden Mark Department of Neurology, Leicester General Hospital, University Hospitals of Leicester, Leicester, UK aut NATIONALLICENCE 700 1- Sivaguru Arul Department of Neurology, City Hospital, Sandwell and West Birmingham Hospitals NHS Trust, Birmingham, UK aut NATIONALLICENCE 700 1- Furmston Alexandra Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK aut NATIONALLICENCE 700 1- Howell Steven Department of Neurology, Royal Hallamshire Hospital, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK aut NATIONALLICENCE 700 1- Sharrack Basil Department of Neurology, Royal Hallamshire Hospital, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK aut NATIONALLICENCE 700 1- Davies M. Department of Neurology, University Hospital of North Staffordshire NHS Trust, Stoke-on-Trent, UK aut NATIONALLICENCE 700 1- Sinclair Alexandra Academic Unit of Ophthalmology, School of Immunology, Infection and Inflammation, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK aut NATIONALLICENCE 700 1- Clarke Carl Department of Neurology, School of Experimental Medicine, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK aut NATIONALLICENCE 773 0- Journal of Neurology Springer-Verlag 258/5(2011-05-01), 874-881 0340-5354 258:5<874 2011 258 415 Metadata rights reserved Springer special CC-BY-NC licence nationallicence BK010053 XK010053 XK010000 NATIONALLICENCE NATIONALLICENCE NL-springer