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Table 1 Summary of clinical trials with NGF on peripheral neuropathies

From: Nerve growth factor: from the early discoveries to the potential clinical use

Disease Study type NGF type and dosage Delivery route Outcome Side effects References
Healthy subjects Phase I double-masked, randomized, placebo-controlled study. Recombinant human NGF. Doses ranging from 0.03 to 1 μg/kg. Subcutaneous, intravenous. The study evaluated the safety of single doses of rhNGF in healthy human volunteers. No life-threatening adverse events were seen at any dose. Dose-dependent mild to moderate muscle pain and hyperalgesia at the injection site was reported. [84, 85]
Diabetic polyneuropathy Phase II, placebo-controlled clinical trial. Recombinant human NGF. 0.1 and 0.3 μg/kg. Subcutaneous. Significant improvement of neuropathic symptoms after 6 months of treatment. Dose-dependent hyperalgesia at the injection site. [86, 87]
  Phase III, randomized, double-blind, placebo-controlled clinical trial. Recombinant human NGF. 0.1 μg/kg. Subcutaneous. Not significant compared to placebo. Dose-dependent hyperalgesia at the injection site. [87, 88]
HIV-associated peripheral neuropathy Phase II, multicenter, placebo-controlled, randomized clinical trial. Recombinant human NGF. 0.1 and 0.3 μg/kg. Subcutaneous. Significant improvements in daily and global pain assessments. Injection site pain. Severe transient myalgic pain. [92, 93]
  Long term (48 weeks) phase II, multicenter, placebo-controlled, randomized clinical trial. Recombinant human NGF. 0.1 and 0.3 μg/kg. Subcutaneous. No improvement in neuropathy severity. Injection site pain. [94]