Guidelines of the International Headache Society for Controlled Clinical Trials in Idiopathic Intracranial Hypertension

Susan P Mollan^{1

2}, Clare L Fraser³, Kathleen B Digre⁴, Hans-Christoph Diener⁵, Richard B Lipton⁶, Marianne Juhler^{7

8}, Neil R Miller⁹, Patricia Pozo-Rosich^{10

11}, Mansoureh Togha^{12

13}, Kristian Brock¹⁴, Marc J Dinkin^{15

16}, Carmen K M Chan^{17

18}, Cristina Tassorelli^{19

20}, Alex J Sinclair^{2

21}, Gisela M Terwindt²², Rigmor H Jensen²³

Affiliations

¹ Neuro-ophthalmology, Queen Elizabeth Hospital, University Hospital Birmingham NHS Foundation Trust, Birmingham, Birmingham, UK.
² Translational Brain Science, Institute of Metabolism and Systems Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.
³ Save Sight Institute, University of Sydney, Sydney, NSW, Australia.
⁴ Neuro-ophthalmology Division, John A. Moran Eye Center, University of Utah, Salt Lake City, USA.
⁵ Institut für Medizinische Informatik, Biometrie undEpidemiologie (IMIBE), Medizinische Fakultät der Universität Duisburg-Essen, Essen, Germany.
⁶ The Saul R. Korey Department of Neurology, and the Montefiore Headache Center, Albert Einstein College of Medicine, Bronx, New York, USA.
⁷ Department of Neurosurgery, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.
⁸ Institute of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.
⁹ Wilmer Eye Institute and Departments of Ophthalmology, Neurology, and Neurosurgery, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
¹⁰ Headache Unit, Neurology Department, Hospital Universitari Vall d'Hebron, Barcelona, Spain.
¹¹ Headache and Neurological Pain Research Group, Vall d'Hebron Research Institute, Department of Medicine, Universitat Autònoma de Barcelona, Barcelona, Spain.
¹² Headache Department, Iranian Centre of Neurological Research, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran.
¹³ Headache Department, Neurology Ward, Sina Hospital, School of Medicine, Tehran University of Medical Sciences, Tehran, Iran.
¹⁴ Cancer Research Clinical Trials Unit, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.
¹⁵ Department of Ophthalmology, Weill Cornell Medical College, NY Presbyterian Hospital, New York, New York, USA.
¹⁶ Department of Neurology, Weill Cornell Medical College, NY Presbyterian Hospital, New York, New York, USA.
¹⁷ Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong SAR, China.
¹⁸ Hong Kong Eye Hospital, Hong Kong SAR, China.
¹⁹ Unit of Translational Neurovascular Research, IRCCS Mondino Foundation, 27100, Pavia, Italy.
²⁰ Department of Brain and Behavioural Sciences, University of Pavia, 27100, Pavia, Italy.
²¹ Department of Neurology, University Hospitals Birmingham, Queen Elizabeth Hospital, Birmingham, UK.
²² Department of Neurology, Leiden University Medical Center, Leiden, the Netherlands.
²³ Department of Neurology, Danish Headache Center, Rigshospitalet-Glostrup, University of Copenhagen, Copenhagen, Denmark.

PMID: 37661711
DOI: 10.1177/03331024231197118

Free article

Practice Guideline

Guidelines of the International Headache Society for Controlled Clinical Trials in Idiopathic Intracranial Hypertension

Susan P Mollan et al. Cephalalgia. 2023 Aug.

Free article

. 2023 Aug;43(8):3331024231197118.

doi: 10.1177/03331024231197118.

Authors

Affiliations

¹ Neuro-ophthalmology, Queen Elizabeth Hospital, University Hospital Birmingham NHS Foundation Trust, Birmingham, Birmingham, UK.
² Translational Brain Science, Institute of Metabolism and Systems Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.
³ Save Sight Institute, University of Sydney, Sydney, NSW, Australia.
⁴ Neuro-ophthalmology Division, John A. Moran Eye Center, University of Utah, Salt Lake City, USA.
⁵ Institut für Medizinische Informatik, Biometrie undEpidemiologie (IMIBE), Medizinische Fakultät der Universität Duisburg-Essen, Essen, Germany.
⁶ The Saul R. Korey Department of Neurology, and the Montefiore Headache Center, Albert Einstein College of Medicine, Bronx, New York, USA.
⁷ Department of Neurosurgery, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.
⁸ Institute of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.
⁹ Wilmer Eye Institute and Departments of Ophthalmology, Neurology, and Neurosurgery, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
¹⁰ Headache Unit, Neurology Department, Hospital Universitari Vall d'Hebron, Barcelona, Spain.
¹¹ Headache and Neurological Pain Research Group, Vall d'Hebron Research Institute, Department of Medicine, Universitat Autònoma de Barcelona, Barcelona, Spain.
¹² Headache Department, Iranian Centre of Neurological Research, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran.
¹³ Headache Department, Neurology Ward, Sina Hospital, School of Medicine, Tehran University of Medical Sciences, Tehran, Iran.
¹⁴ Cancer Research Clinical Trials Unit, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.
¹⁵ Department of Ophthalmology, Weill Cornell Medical College, NY Presbyterian Hospital, New York, New York, USA.
¹⁶ Department of Neurology, Weill Cornell Medical College, NY Presbyterian Hospital, New York, New York, USA.
¹⁷ Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong SAR, China.
¹⁸ Hong Kong Eye Hospital, Hong Kong SAR, China.
¹⁹ Unit of Translational Neurovascular Research, IRCCS Mondino Foundation, 27100, Pavia, Italy.
²⁰ Department of Brain and Behavioural Sciences, University of Pavia, 27100, Pavia, Italy.
²¹ Department of Neurology, University Hospitals Birmingham, Queen Elizabeth Hospital, Birmingham, UK.
²² Department of Neurology, Leiden University Medical Center, Leiden, the Netherlands.
²³ Department of Neurology, Danish Headache Center, Rigshospitalet-Glostrup, University of Copenhagen, Copenhagen, Denmark.

PMID: 37661711
DOI: 10.1177/03331024231197118

Abstract

The quality of clinical trials is essential to advance treatment, inform regulatory decisions and meta-analysis. With the increased incidence of idiopathic intracranial hypertension and the emergence of clinical trials for novel therapies in this condition, the International Headache Society Guidelines for Controlled Clinical Trials in Idiopathic Intracranial Hypertension aims to establish guidelines for designing state-of-the-art controlled clinical trials for idiopathic intracranial hypertension.

Keywords: Guidelines; Idiopathic intracranial hypertension; Pseudotumor cerebri; Randomised control trial; drug; headache; lumbar puncture; papilloedema; raised intracranial pressure; vision.

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Clinical trials for idiopathic intracranial hypertension: what are we treating?
Biousse V, Newman NJ. Biousse V, et al. Nat Rev Neurol. 2024 Jan;20(1):3-4. doi: 10.1038/s41582-023-00892-1. Nat Rev Neurol. 2024. PMID: 37923819 No abstract available.

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Guidelines of the International Headache Society for Controlled Clinical Trials in Idiopathic Intracranial Hypertension

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Guidelines of the International Headache Society for Controlled Clinical Trials in Idiopathic Intracranial Hypertension

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