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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]