O’Dwyer, Rebecca http://orcid.org/0000-0003-2461-8457
Stern, Sean
Wade, Clarence T.
Guggilam, Anuradha
Rosenfeld, William E.
Clinical trials referenced in this document:
Documents that mention this clinical trial
Safety and Efficacy of Cenobamate for the Treatment of Focal Seizures in Older Patients: Post Hoc Analysis of a Phase III, Multicenter, Open-Label Study
https://doi.org/10.1007/s40266-024-01102-3
Funding for this research was provided by:
SK Life Science
Article History
Accepted: 16 January 2024
First Online: 6 March 2024
Declarations
:
: O’Dwyer R, et al. Safety and efficacy of cenobamate for the treatment of focal seizures in older patients. Presented at the American Epilepsy Society 2022 Annual Meeting, 2–6 December 2022, Nashville, TN, USA (Poster 1.292) and encored at the American Academy of Neurology 2023 Annual Meeting, 22–27 April 2023, Boston, MA, USA (Poster P4.002).
: This study was supported by SK Life Science, Inc.
: Rebecca O’Dwyer is a consultant/advisor for SK Life Science, Inc. Sean Stern, Clarence T. Wade, and Anuradha Guggilam are employees of SK Life Science, Inc. William E. Rosenfeld is a consultant/advisor for SK Life Science, Inc.; speaker for SK Life Science, Inc.; and has received research support from SK Life Science, Inc. and UCB Pharma.
: The original phase III study was conducted in accordance with the ethical principles of Good Clinical Practice, according to the International Conference on Harmonisation guidelines and all applicable country-specific regulations. The study protocol was approved by an independent Ethics Committee or Institutional Review Board at each site according to local regulations.
: Written informed consent was obtained from each patient prior to the original phase III study; no new patient consent was required for this post hoc analysis.
: Not applicable.
: The data for the analyses described in this manuscript are available by request from the corresponding author or SK Life Science, Inc., the company sponsoring the clinical development of cenobamate for the treatment of focal epilepsy.
: Not applicable.
: Conceptualization: RO, SS, CTW, AG, and WER. Acquisition of data: SS, CTW, and WER. Statistical analysis: SS and CTW. Data interpretation: RO, SS, CTW, AG, and WER. All authors were involved in critically revising the manuscript, reviewed the final manuscript, and gave approval for submission.