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Adaptive Platform Trials to Transform Amyotrophic Lateral Sclerosis Therapy Development.
Paganoni S, Berry JD, Quintana M, Macklin E, Saville BR, Detry MA, Chase M, Sherman AV, Yu H, Drake K, Andrews J, Shefner J, Chibnik LB, Vestrucci M, Cudkowicz ME; Healey ALS Platform Trial Study Group. Paganoni S, et al. Ann Neurol. 2022 Feb;91(2):165-175. doi: 10.1002/ana.26285. Epub 2022 Jan 10. Ann Neurol. 2022. PMID: 34935174 Review.
Design and Statistical Innovations in a Platform Trial for Amyotrophic Lateral Sclerosis.
Quintana M, Saville BR, Vestrucci M, Detry MA, Chibnik L, Shefner J, Berry JD, Chase M, Andrews J, Sherman AV, Yu H, Drake K, Cudkowicz M, Paganoni S, Macklin EA; HEALEY ALS Platform Trial Study Group. Quintana M, et al. Ann Neurol. 2023 Sep;94(3):547-560. doi: 10.1002/ana.26714. Epub 2023 Jun 22. Ann Neurol. 2023. PMID: 37245090
Being PRO-ACTive: What can a Clinical Trial Database Reveal About ALS?
Zach N, Ennist DL, Taylor AA, Alon H, Sherman A, Kueffner R, Walker J, Sinani E, Katsovskiy I, Cudkowicz M, Leitner ML. Zach N, et al. Among authors: katsovskiy i. Neurotherapeutics. 2015 Apr;12(2):417-23. doi: 10.1007/s13311-015-0336-z. Neurotherapeutics. 2015. PMID: 25613183 Free PMC article. Review.
The PRO-ACT database: design, initial analyses, and predictive features.
Atassi N, Berry J, Shui A, Zach N, Sherman A, Sinani E, Walker J, Katsovskiy I, Schoenfeld D, Cudkowicz M, Leitner M. Atassi N, et al. Among authors: katsovskiy i. Neurology. 2014 Nov 4;83(19):1719-25. doi: 10.1212/WNL.0000000000000951. Epub 2014 Oct 8. Neurology. 2014. PMID: 25298304 Free PMC article.
A randomized trial of mexiletine in ALS: Safety and effects on muscle cramps and progression.
Weiss MD, Macklin EA, Simmons Z, Knox AS, Greenblatt DJ, Atassi N, Graves M, Parziale N, Salameh JS, Quinn C, Brown RH Jr, Distad JB, Trivedi J, Shefner JM, Barohn RJ, Pestronk A, Swenson A, Cudkowicz ME; Mexiletine ALS Study Group. Weiss MD, et al. Neurology. 2016 Apr 19;86(16):1474-81. doi: 10.1212/WNL.0000000000002507. Epub 2016 Feb 24. Neurology. 2016. PMID: 26911633 Free PMC article. Clinical Trial.