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10.1212/NXI.0000000000000100 http://scihub22266oqcxt.onion/10.1212/NXI.0000000000000100 C4396529!4396529!25884010     free     free     free Deprecated: Implicit conversion from float 227.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 227.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 227.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 227.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 227.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 227.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 227.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534       Neurol+Neuroimmunol+Neuroinflamm 2015 ; 2 (3): ä Nephropedia Template TP {{tp|p=25884010|t=2015. Randomized phase 2 trial of NP001?a novel immune regulator: Safety and early efficacy in ALS |pdf=|usr=}}{{25884010}} gab.com Text Randomized phase 2 trial of NP001 a novel immune regulator: Safety and early efficacy in ALS JO: Neurol Neuroimmunol Neuroinflamm http://www.kidney.de/pget.php?&tw=1&pmid=25884010 #FOAvip 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 <3 years' duration and forced vital capacity ?70%. Participants received NP001 2 mg/kg, NP001 1 mg/kg, or placebo for 6 months. Safety, tolerability, and inflammatory biomarkers were assessed throughout the study. Preliminary efficacy was evaluated using the ALS Functional Rating Scale-Revised (ALSFRS-R) slope and change from baseline, with and without matched historical placebo controls, after 6 months of treatment. A post hoc analysis of the percentage of patients (?responders?) whose ALSFRS-R did not change from baseline was also conducted. Results:: NP001 was generally safe and well-tolerated, except for infusion site pain and dizziness. No significant slowing of decline in the primary or secondary measures was observed. However, slowing of progression was observed in the high-dose group in patients with greater inflammation (wide range C-reactive protein). Moreover, NP001 may have dose dependently halted symptom progression in a subset of patients. More than 2 times as many patients on high-dose NP001 (25%) did not progress during 6 months of treatment compared with those on placebo (11%). Most ?responders? had an elevated biomarker of inflammation, interleukin-18, and were positive for lipopolysaccharide at baseline, which decreased after treatment with NP001. Conclusion:: The arresting of progression of ALS symptoms by NP001 in a subset of patients with marked neuroinflammation, as observed here, will represent a novel therapeutic approach for patients with ALS, if confirmed. Classification of evidence:: This study provides Class I evidence that for patients with ALS, NP001 is safe and did not significantly slow progression of the disease (difference in slope of the ALSFRS-R/month 0.12 favoring NP001, p = 0.55). The study lacks the precision to exclude an important effect of NP001. Twit Text FOAVip Randomized phase 2 trial of NP001 a novel immune regulator: Safety and early efficacy in ALS ????Neurol Neuroimmunol Neuroinflamm http://www.kidney.de/pget.php?&tw=1&pmid=25884010 #FOAvip Twit Text # Free Paper on # # # # # LINK http://www.kidney.de/pget.php?&tw=1&pmid=25884010 #FOAvip English Wikipedia <ref>{{Cite pmid|25884010}}</ref> Randomized phase 2 trial of NP001?a novel immune regulator: Safety and early efficacy in ALS #MMPMID25884010 Miller RG; Block G; Katz JS; Barohn RJ; Gopalakrishnan V; Cudkowicz M; Zhang JR; McGrath MS; Ludington E; Appel SH; Azhir A; Katz J; Kushner G; Wong C; Engel M; Forshew D; Osborne R; Schug B; Akers A; Brent B; Zayas-Bazan T; McCoy S; Goyal N; Harris W; Gonella M; Brooks BR; Bravver E; Sanjak M; Ward AL; Mehrizi A; Belfiore M; Lary C; Nemeth J; Conway J; Bender R; Holsten S; Shue J; Mitsumoto H; Youngman R; Armstrong N; Lee Yw; Weimer LH; Brannagan T; Hirano M; Scotto M; Dalton K; Bedlack RS; Morgenlander JC; Boyette CL; Grace KL; Arvik BM; Thomas Hickey P; Lasater Scott B; Lynn Heydt D; Perry-Trice P; Cudkowicz M; Berry J; Atassi N; Boylan K; Kennelly K; DeSaro P; Johnston A; Huser A; Fuqua P; Staggs K; Babcock L; Kryston T; Ross MA; Bosch EP; Verheijde JL; Grover Y; Duffy AK; Lee MS; McLaughlin RR; Musil DJ; Early J; Whiteman D; Wisbey JA; Simpson EP; Pleitez MY; Lay LF; Halton SL; Schwartz T; Blanton L; Lai EC; Pioro EP; Kuenzler R; Berry N; Khan S; Chowdhury N; Biernot J; Goslin K; Carter GT; Corkrey PM; Ann Kovarik M; Shefner JM; Simionescu L; Grosso M; Watson ML; Reale MA; Duleep A; Carhart R; Markis K; Money K; Boevin T; Lava N; Glass JD; Polak M; Shaw L; Bordeau J; Rogers S; Ferguson S; Fournier C; Kelly C; Mozaffar T; Wang AK; Ramsey G; Tully PA; Graves M; Wiedau-Pazos M; Alvarez R; Barohn R; McVey AL; Dimachkie MM; Pasnoor M; Herbelin L; Walsh M; Kasarskis EJ; Dotson WF; Sitzlar SC; Tandy T; Carrico J; Phillips S; Rice L; Holbrook KM; Eckmann D; Chamblin L; Townsend J; Kaenzig J; Hanley-Borgia L; Vanderpool KE; Taylor DG; Carpenter J; Thomas S; Hutchinson J; King JT Neurol Neuroimmunol Neuroinflamm 2015[Jun]; 2 (3): ä PMID25884010show ga 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 <3 years' duration and forced vital capacity ?70%. Participants received NP001 2 mg/kg, NP001 1 mg/kg, or placebo for 6 months. Safety, tolerability, and inflammatory biomarkers were assessed throughout the study. Preliminary efficacy was evaluated using the ALS Functional Rating Scale-Revised (ALSFRS-R) slope and change from baseline, with and without matched historical placebo controls, after 6 months of treatment. A post hoc analysis of the percentage of patients (?responders?) whose ALSFRS-R did not change from baseline was also conducted. Results:: NP001 was generally safe and well-tolerated, except for infusion site pain and dizziness. No significant slowing of decline in the primary or secondary measures was observed. However, slowing of progression was observed in the high-dose group in patients with greater inflammation (wide range C-reactive protein). Moreover, NP001 may have dose dependently halted symptom progression in a subset of patients. More than 2 times as many patients on high-dose NP001 (25%) did not progress during 6 months of treatment compared with those on placebo (11%). Most ?responders? had an elevated biomarker of inflammation, interleukin-18, and were positive for lipopolysaccharide at baseline, which decreased after treatment with NP001. Conclusion:: The arresting of progression of ALS symptoms by NP001 in a subset of patients with marked neuroinflammation, as observed here, will represent a novel therapeutic approach for patients with ALS, if confirmed. Classification of evidence:: This study provides Class I evidence that for patients with ALS, NP001 is safe and did not significantly slow progression of the disease (difference in slope of the ALSFRS-R/month 0.12 favoring NP001, p = 0.55). The study lacks the precision to exclude an important effect of NP001. äRandomized phase 2 trial of NP001?a novel immune regulator: Safety and(epmc).pdf DeepDyve Pubget Overpricing