- •Differences in primary endpoint (NC measures and HRdb) were not significant.
- •Changes in IENF density with tanezumab were not significant versus placebo.
- •Tanezumab significantly improved pain, physical function, and PGA of OA.
- •Differences in the clinical neuropathy assessments were not significant.
- •Safety was similar to previous tanezumab clinical trials.
Abbreviations:5 HT (serotonin), 5NC (5 individual NC tests), ASIC3 (acid-sensing ion channel 3), BDNF (brain-derived neurotrophic factor), BR2 (bradykinin receptor), CB1 (cannabinoid receptor 1), CGRP (calcitonin gene-related peptide), CI (confidence interval), CMAP (compound muscle action potential), DRG (dorsal root ganglia), H+ (proton), HRdb (heart rate deep breathing), IENF (intraepidermal nerve fiber), IPAP (Initial Pain Assessment Period), ITT (intent-to-treat), IV (intravenous), LLF (lower limb function), LOCF (last observation carried forward), LSM (least squares mean), MNCV (motor nerve conduction velocity), MNDL (motor nerve distal latency), NaV 1.8 (voltage-gated sodium channel 1.8), NC (nerve conduction), nd (normal deviate), NGF (nerve growth factor), NIS (neuropathy impairment score), NIS-R (NIS muscle stretch reflexes), NIS-S (NIS sensation), NIS-W (NIS weakness), NRS (numeric rating scale), NSC (neuropathy symptoms and change), NV (neurology visit), OA (osteoarthritis), P2X3 (purinergic 2X receptor 3), p75 (low-affinity p75 neurotrophin receptor), PGA (Patient's Global Assessment), PPAS (per-protocol analysis set), RV (recruitment site visit), SD (standard deviation), SE (standard error), SNAP (sensory nerve action potential), SP (substance P), trkA (tropomyosin-related kinase A), TrpA1 (transient receptor potential ankyrin subtype 1), TrpV1 (transient receptor potential vanilloid 1), WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index)
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