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Review
. 2022 Sep;63 Suppl 1(Suppl 1):S55-S68.
doi: 10.1111/epi.17363.

Future opportunities for research in rescue treatments

James W Wheless  1 , Daniel Friedman  2 , Gregory L Krauss  3 , Vikram R Rao  4 , Michael R Sperling  5 , Enrique Carrazana  6   7 , Adrian L Rabinowicz  6
Affiliations
Review

Future opportunities for research in rescue treatments

James W Wheless et al. Epilepsia. 2022 Sep.

Abstract

Clinical studies of rescue medications for seizure clusters are limited and are designed to satisfy regulatory requirements, which may not fully consider the needs of the diverse patient population that experiences seizure clusters or utilize rescue medication. The purpose of this narrative review is to examine the factors that contribute to, or may influence the quality of, seizure cluster research with a goal of improving clinical practice. We address five areas of unmet needs and provide advice for how they could enhance future trials of seizure cluster treatments. The topics addressed in this article are: (1) unaddressed end points to pursue in future studies, (2) roles for devices to enhance rescue medication clinical development programs, (3) tools to study seizure cluster prediction and prevention, (4) the value of other designs for seizure cluster studies, and (5) unique challenges of future trial paradigms for seizure clusters. By focusing on novel end points and technologies with value to patients, caregivers, and clinicians, data obtained from future studies can benefit the diverse patient population that experiences seizure clusters, providing more effective, appropriate care as well as alleviating demands on health care resources.

Keywords: benzodiazepines; clinical trials; rescue medication; seizure clusters; seizures.

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Conflict of interest statement

Dr Wheless has served as an advisor or consultant for CombiMatrix; Eisai Inc.; GW Pharmaceuticals; Lundbeck, Inc.; Neurelis, Inc.; NeuroPace, Inc.; Supernus Pharmaceuticals, Inc.; and Upsher‐Smith Laboratories, Inc. Dr Wheless has served as a speaker or a member of a speakers bureau for Cyberonics, Inc.; Eisai Inc.; Lundbeck, Inc.; Mallinckrodt; Neurelis, Inc.; Supernus Pharmaceuticals, Inc.; and Upsher‐Smith Laboratories, Inc., and has received grants for clinical research from Acorda Therapeutics; GW Pharmaceuticals; Insys Therapeutics, Inc.; Lundbeck, Inc.; Mallinckrodt; Neurelis, Inc.; NeuroPace, Inc.; Upsher‐Smith Laboratories, Inc.; and Zogenix, Inc. Dr Friedman receives salary support for consulting and clinical trial‐related activities performed on behalf of The Epilepsy Study Consortium, a nonprofit organization. Dr Friedman receives no personal income for these activities. New York University (NYU) receives a fixed amount from the Epilepsy Study Consortium toward Dr Friedman's salary. Within the past 2 years, The Epilepsy Study Consortium received payments for research services performed by Dr Friedman from Axcella, Biogen, Cerevel, Crossject, Engage Pharmaceuticals, Eisai, Lundbeck, Pfizer, SK Life Science, Xenon, and Zynerba. In addition, he has served as a paid consultant for Eisai and Neurelis, Inc. He has received travel support from Medtronics, Eisai, and the Epilepsy Foundation. He has received research support from the Centers for Disease Control and Prevention (CDC), National Institute for Neurological Disorders and Stroke (NINDS), Epilepsy Foundation, Empatica, Epitel, UCB Inc., and Neuropace. He serves on the scientific advisory board for Receptor Life Sciences. He holds equity interests in Neuroview Technology and Receptor Life Sciences. He received royalty income from Oxford University Press. Dr Krauss has served as a consultant/advisor for Adamas, Eisai, Otsuka, and Shire. He has received research support from Biogen, SK Life Science, UCB Pharma, and Upsher‐Smith Laboratories, Inc. Dr Rao has served as a consultant for NeuroPace, Inc., manufacturer of the RNS System. Dr Sperling has received compensation for speaking at continuing medical education programs from Medscape, Projects for Knowledge, International Medical Press, and UCB Pharma. He is an advisor for scientific publications for Neurelis, Inc. He consults for Medtronic with payments to Thomas Jefferson University. He has received research support from Eisai Inc.; Medtronic; Neurelis, Inc.; SK Life Science; Takeda; Xenon; Cerevel; UCB Pharma; Janssen; Equilibre; and Engage Pharmaceuticals. He has received royalties from Oxford University Press and Cambridge University Press. Dr Carrazana is an employee of and has received stock and stock options from Neurelis, Inc. Dr Rabinowicz is an employee and has received stock options from Neurelis, Inc. We confirm that we have read the Journal's position on issues involved in ethical publication and affirm that this report is consistent with those guidelines.

Figures

FIGURE 1
FIGURE 1
Potential study design for rescue medication.
See this image and copyright information in PMC

References

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