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Title: EEG parameters as endpoints in epilepsy clinical trials - An expert panel opinion paper.
Austin Authors: Buchhalter, Jeffrey;Neuray, Caroline;Cheng, Jocelyn Y;D'Cruz, O'Neill;Datta, Alexandre N;Dlugos, Dennis;French, Jacqueline;Haubenberger, Dietrich;Hulihan, Joseph;Klein, Pavel;Komorowski, Robert W;Kramer, Lynn;Lothe, Amélie;Nabbout, Rima;Perucca, Emilio;der Ark, Peter Van
Affiliation: Medicine (University of Melbourne)
Buchhalter Consulting, PLLC, 13030 N. 17th Place, Phoenix, AZ, USA..
Department of Neurology, Neurocritical Care, and Neurorehabilitation, Christian Doppler University Hospital, Centre for Cognitive Neuroscience, Paracelsus Medical University, Salzburg, Austria..
Neurology Business Group, Eisai Inc., 200 Metro Blvd. Nutley, NJ 07110, USA..
OD Consulting and Neurological Services, PLLC, 825 Deseret Lane, Chapel Hill, NC 27516, USA..
Pediatric Neurology and Developmental Medicine Department, University Children's Hospital UKBB, University of Basel, Switzerland..
Departments of Neurology and Pediatrics, Children's Hospital of Philadelphia, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA USA..
Department of Neurology NYU Langone Health, NYU Grossman School of Medicine, USA..
Neurocrine Biosciences Inc., San Diego, CA, USA..
Marinus, 5 Radnor Corporate Center, 100 Matsonford Rd, Suite 500, Radnor, PA 19087, USA..
Mid-Atlantic Epilepsy and Sleep Center, 6410 Rockledge Drive, Suite 610, Bethesda, MD 20817, USA..
Ionis Pharmaceuticals Inc, 2855 Gazelle Court, Carlsbad, CA 92010, USA..
EisaiInc, 100 Tice Blvd, Woodcliff Lake, NJ, USA..
Zogenix International (now part of UCB), The Pearce Building, West Street, SL6 1RL Maidenhead, United Kingdom..
Reference Centre for Rare Epilepsies, Department of Pediatric Neurology, Necker Enfants Malades hospital, Université de Paris cité, Institut Imagine, Paris, France..
Janssen Research & Development, Turnhoutseweg 30, 2340 Beerse, Belgium..
Issue Date: 29-Sep-2022
Date: 2022
Publication information: Epilepsy Research 2022; 187: 107028
Abstract: The lack of ideal measurement of treatment efficacy is a well acknowledged problem in the epilepsy community, both in clinical care and clinical trials. Whilst still the current gold-standard, self-reported seizure frequency significantly underestimates the true number of seizures and does not account for any other at least equally important outcome parameters, such as neurodevelopment and cognition. With the rise of disease modifying treatments, the need for more reliable endpoints in practice and clinical trials becomes more pressing. In this paper we assembled an expert panel to discuss the nature of these needs, current limitations, and obstacles based on a survey amongst these experts who were queried about the most important issues regarding the use of electroencephalography (EEG) parameters as endpoints in clinical drug and device development. A structured survey was sent to a group of experts in the design and conduct of epilepsy trials in adults and children. This was followed by a virtual in-person meeting discussing the results of the trial and identifying a list of most important issues. Six clinical trialists and 5 individuals from pharmaceutical companies returned the survey containing 14 questions, and 8 clinical trialists and 10 pharma-representatives attended the meeting. Three main issues were identified (1) lack of accuracy of seizure diaries due to nocturnal seizures, subtle motor seizures, impairment of consciousness and lack of awareness of the seizure by the patient (2) inter-rater variability of EEG assessment (3) lack of standardization regarding definition(s) of seizures (clinical and electrographic), EEG recording methods and EEG data management. Recommended solutions included (1) validation of EEG parameters as biomarkers and use of wearables (2) development of a manual that describes EEG rating criteria, protocol for validation by > 1 central reader and use of a resolution of disagreements reporting template (3) standardization of EEG recording, data management and reporting. Current developments in research and technology seem promising to advance the use of EEG parameters as potential endpoints and offer partial solutions to the current needs. However, continuous, focused and collaborative efforts of all stakeholders (academia, industry and regulatory agencies) are needed to formulate guidelines, validate emerging technologies and approve them for use in trials. It is the intent of this opinion "position paper" to stimulate those efforts.
DOI: 10.1016/j.eplepsyres.2022.107028
Journal: Epilepsy Research
PubMed URL: 36270075
Type: Journal Article
Subjects: Anti-seizure medications
Clinical trials
Appears in Collections:Journal articles

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