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COURAGE-ALS: a randomized, double-blind phase 3 study designed to improve participant experience and increase the probability of success.
Shefner JM, Al-Chalabi A, Andrews JA, Chio A, De Carvalho M, Cockroft BM, Corcia P, Couratier P, Cudkowicz ME, Genge A, Hardiman O, Heiman-Patterson T, Henderson RD, Ingre C, Jackson CE, Johnston W, Lechtzin N, Ludolph A, Maragakis NJ, Miller TM, Mora Pardina JS, Petri S, Simmons Z, Van Den Berg LH, Zinman L, Kupfer S, Malik FI, Meng L, Simkins TJ, Wei J, Wolff AA, Rudnicki SA. Shefner JM, et al. Among authors: andrews ja. Amyotroph Lateral Scler Frontotemporal Degener. 2023 Aug;24(5-6):523-534. doi: 10.1080/21678421.2023.2216223. Epub 2023 May 30. Amyotroph Lateral Scler Frontotemporal Degener. 2023. PMID: 37254449 Clinical Trial.
Phase II trial of CoQ10 for ALS finds insufficient evidence to justify phase III.
Kaufmann P, Thompson JL, Levy G, Buchsbaum R, Shefner J, Krivickas LS, Katz J, Rollins Y, Barohn RJ, Jackson CE, Tiryaki E, Lomen-Hoerth C, Armon C, Tandan R, Rudnicki SA, Rezania K, Sufit R, Pestronk A, Novella SP, Heiman-Patterson T, Kasarskis EJ, Pioro EP, Montes J, Arbing R, Vecchio D, Barsdorf A, Mitsumoto H, Levin B; QALS Study Group. Kaufmann P, et al. Ann Neurol. 2009 Aug;66(2):235-44. doi: 10.1002/ana.21743. Ann Neurol. 2009. PMID: 19743457 Free PMC article. Clinical Trial.
Web-based data management for a phase II clinical trial in ALS.
Buchsbaum R, Kaufmann P, Barsdorf AI, Arbing R, Montes J, Thompson JL; QALS Study Group. Buchsbaum R, et al. Amyotroph Lateral Scler. 2009 Oct-Dec;10(5-6):374-7. doi: 10.3109/17482960802378998. Amyotroph Lateral Scler. 2009. PMID: 19922127 Free PMC article.
Safety and efficacy of lithium in combination with riluzole for treatment of amyotrophic lateral sclerosis: a randomised, double-blind, placebo-controlled trial.
Aggarwal SP, Zinman L, Simpson E, McKinley J, Jackson KE, Pinto H, Kaufman P, Conwit RA, Schoenfeld D, Shefner J, Cudkowicz M; Northeast and Canadian Amyotrophic Lateral Sclerosis consortia. Aggarwal SP, et al. Lancet Neurol. 2010 May;9(5):481-8. doi: 10.1016/S1474-4422(10)70068-5. Epub 2010 Apr 1. Lancet Neurol. 2010. PMID: 20363190 Free PMC article. Clinical Trial.
Dexpramipexole versus placebo for patients with amyotrophic lateral sclerosis (EMPOWER): a randomised, double-blind, phase 3 trial.
Cudkowicz ME, van den Berg LH, Shefner JM, Mitsumoto H, Mora JS, Ludolph A, Hardiman O, Bozik ME, Ingersoll EW, Archibald D, Meyers AL, Dong Y, Farwell WR, Kerr DA; EMPOWER investigators. Cudkowicz ME, et al. Lancet Neurol. 2013 Nov;12(11):1059-67. doi: 10.1016/S1474-4422(13)70221-7. Epub 2013 Sep 23. Lancet Neurol. 2013. PMID: 24067398 Clinical Trial.
ALS Multicenter Cohort Study of Oxidative Stress (ALS COSMOS): study methodology, recruitment, and baseline demographic and disease characteristics.
Mitsumoto H, Factor-Litvak P, Andrews H, Goetz RR, Andrews L, Rabkin JG, McElhiney M, Nieves J, Santella RM, Murphy J, Hupf J, Singleton J, Merle D, Kilty M, Heitzman D, Bedlack RS, Miller RG, Katz JS, Forshew D, Barohn RJ, Sorenson EJ, Oskarsson B, Fernandes Filho JA, Kasarskis EJ, Lomen-Hoerth C, Mozaffar T, Rollins YD, Nations SP, Swenson AJ, Shefner JM, Andrews JA, Koczon-Jaremko BA; ALS COSMOS Study Group. Mitsumoto H, et al. Among authors: andrews h, andrews ja, andrews l. Amyotroph Lateral Scler Frontotemporal Degener. 2014 Jun;15(3-4):192-203. doi: 10.3109/21678421.2013.864312. Epub 2014 Feb 24. Amyotroph Lateral Scler Frontotemporal Degener. 2014. PMID: 24564738 Free PMC article.
Longitudinal modeling to predict vital capacity in amyotrophic lateral sclerosis.
Jahandideh S, Taylor AA, Beaulieu D, Keymer M, Meng L, Bian A, Atassi N, Andrews J, Ennist DL. Jahandideh S, et al. Amyotroph Lateral Scler Frontotemporal Degener. 2018 May;19(3-4):294-302. doi: 10.1080/21678421.2017.1418003. Epub 2017 Dec 20. Amyotroph Lateral Scler Frontotemporal Degener. 2018. PMID: 29260584
Improved stratification of ALS clinical trials using predicted survival.
Berry JD, Taylor AA, Beaulieu D, Meng L, Bian A, Andrews J, Keymer M, Ennist DL, Ravina B. Berry JD, et al. Ann Clin Transl Neurol. 2018 Mar 9;5(4):474-485. doi: 10.1002/acn3.550. eCollection 2018 Apr. Ann Clin Transl Neurol. 2018. PMID: 29687024 Free PMC article.
Revised Airlie House consensus guidelines for design and implementation of ALS clinical trials.
van den Berg LH, Sorenson E, Gronseth G, Macklin EA, Andrews J, Baloh RH, Benatar M, Berry JD, Chio A, Corcia P, Genge A, Gubitz AK, Lomen-Hoerth C, McDermott CJ, Pioro EP, Rosenfeld J, Silani V, Turner MR, Weber M, Brooks BR, Miller RG, Mitsumoto H; Airlie House ALS Clinical Trials Guidelines Group. van den Berg LH, et al. Neurology. 2019 Apr 2;92(14):e1610-e1623. doi: 10.1212/WNL.0000000000007242. Epub 2019 Mar 8. Neurology. 2019. PMID: 30850440 Free PMC article.
173 results