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. | ||
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. | |
 | 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. | |
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. | |
 | 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] |