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June 2015; 2 (3) ArticleOpen Access

Randomized phase 2 trial of NP001, a novel immune regulator

Safety and early efficacy in ALS

Robert G. Miller, Gilbert Block, Jonathan S. Katz, Richard J. Barohn, Vidhya Gopalakrishnan, Merit Cudkowicz, Jane R. Zhang, Michael S. McGrath, Elizabeth Ludington, Stan H. Appel, Ari Azhir
First published April 9, 2015, DOI: https://doi.org/10.1212/NXI.0000000000000100
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Figures

  • Figure 1
    Figure 1 Study design and patient flow

    ALSFRS-R = Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised.

  • Figure 2
    Figure 2 ALSFRS-R changes

    (A) Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) slope after 6 months of treatment without (left) and with (right) historical controls. (B) Mean change from baseline in ALSFRS-R score at week 25 without (left) and with (right) historical controls. (C) ALSFRS-R slope after 6 months of treatment in patients with baseline wide range C-reactive protein (wr-CRP) greater than or equal to the baseline median wr-CRP. Error bars represent standard error.

  • Figure 3
    Figure 3 Responder subset

    (A) Percentage of “responders” (nonprogressing patients) at week 25 after 6 months of treatment; percentage of “responders” in historical controls was 10%. (B) Normalized mean baseline plasma concentrations of inflammatory biomarkers. (C) Mean plasma interleukin (IL)-18 in high-dose “responders” vs “nonresponders” at baseline and after the 6-month treatment period (week 25). (D) Mean plasma lipopolysaccharide (LPS) in all patients treated with 1 mg/kg or 2 mg/kg NP001 at baseline and after the 6-month treatment period (week 25). (E) Mean LPS in placebo “responders” and “nonresponders” at baseline and after the 6-month treatment period (week 25). Error bars represent standard error. Limit of detection (lod) for LPS = 0.05 EU/mL. CRP = C-reactive protein; IFN = interferon.

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