Randomized phase 2 trial of NP001–a novel immune regulator: Safety and early efficacy in ALS

OBJECTIVE:To assess the safety, tolerability, and preliminary efficacy of NP001, a novel immune regulator of inflammatory monocytes/macrophages, for slowing progression of amyotrophic lateral sclerosis (ALS). METHODS:This was a phase 2 randomized, double-blind, placebo-controlled trial of NP001 in 1...

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Veröffentlicht in:Neurology : neuroimmunology & neuroinflammation 2015-06, Vol.2 (3), p.e100-e100
Hauptverfasser: Miller, Robert G, Block, Gilbert, Barohn, Richard J, Cudkowicz, Merit, Zhang, Jane R, McGrath, Michael S, Appel, Stan H, Katz, Jonathan, Kushner, Giovanna, Wong, Cynthia, Akers, Amy, Zayas-Bazan, Thais, McCoy, Shelly, Goyal, Neelam, Harris, Will, Gonella, Marie, Brooks, Benjamin R, Bravver, Elena, Sanjak, Mohammed, Ward, Amber L, Mehrizi, Amir, Belfiore, Mark, Lary, Cynthia, Nemeth, Joanne, Conway, Jill, Holsten, Scott, Shue, Jamie, Mitsumoto, Hiroshi, Youngman, Regina, Lee, Yei-won, Dalton, Kate, Bedlack, Richard S, Morgenlander, Joel Charles, Boyette, Candace Lee, Grace, Karen L, Thomas Hickey, Patrick, Perry-Trice, Peggy, Berry, James, Atassi, Nazem, Boylan, Kevin, Kennelly, Kathleen, DeSaro, Pamela, Johnston, Amelia, Huser, Angela, Fuqua, Paula, Staggs, Kristin, Babcock, Lorraine, Kryston, Thomas, Bosch, E Peter, Verheijde, Josephus L, Grover, Yvvonne, Lee, Michael S, Musil, Danette J, Whiteman, Dana, Simpson, Ericka P, Pleitez, Milvia Y, Lay, Luis F, Schwartz, Thomas, Blanton, Linda, Lai, Eugene C, Berry, Nicole, Khan, Sara, Chowdhury, Nabi, Goslin, Kimberly, Carter, Gregory T, Ann Kovarik, Mary, Simionescu, Laura, Reale, Melissa A, Markis, Katie, Money, Kristina, Boevin, Travis, Lava, Neil, Glass, Jonathan D, Polak, Meraida, Shaw, Latoya, Bordeau, Jane, Rogers, Susan, Ferguson, Susan, Kelly, Crystal, Mozaffar, Tahseen, Ramsey, Gladys, Tully, Patricia A, Alvarez, Rebecca, Barohn, Richard, Dimachkie, Mazen M, Pasnoor, Mamatha, Herbelin, Laura, Kasarskis, Edward J, Dotson, William F, Sitzlar, Stephen C, Tandy, Tammy, Carrico, Jeffery, Rice, Linda, Chamblin, Lisa, Townsend, Janet, Hanley-Borgia, Lisa, Vanderpool, Kathryn E, Taylor, Deborah G, Hutchinson, Jan, King, Jason T
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Sprache:eng
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Zusammenfassung:OBJECTIVE:To assess the safety, tolerability, and preliminary efficacy of NP001, a novel immune regulator of inflammatory monocytes/macrophages, for slowing progression of amyotrophic lateral sclerosis (ALS). METHODS:This was a phase 2 randomized, double-blind, placebo-controlled trial of NP001 in 136 patients with ALS of
ISSN:2332-7812
2332-7812
DOI:10.1212/NXI.0000000000000100