NCT02427464

Phase 3 Gene Therapy for Painful Diabetic Neuropathy

A Phase III, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Safety and Efficacy of VM202 in Participants With Painful Diabetic Peripheral Neuropathy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 507 (actual)
• Sponsor: Helixmith Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the safety and efficacy of bilateral intramuscular injections of VM202 versus placebo in the treatment of painful diabetic peripheral neuropathy. A total of 507 of 477 planned participants were randomized in a 2:1 ratio to one of two treatment groups. Note that 500 participants received Investigational product treatment, whereas 7 participants did not receive Investigational product treatment. Treatments - Engensis (VM202) - 336 Engensis of 318 planned participants Control - Placebo (VM202 vehicle) - 164 Placebo of 159 planned participants Randomization were stratified by current use of gabapentin and/or pregabalin.

Detailed description

Peripheral neuropathy is a serious complication of diabetes. This form of neuropathy carries a high risk of pain, trophic changes, and autonomic dysfunction. Current treatments of diabetic peripheral neuropathy are based on either pathogenetic mechanisms or symptomatic relief. A number of clinical trials have established symptomatic treatment but for pathogenetic mechanisms, the only proven treatment strategy is strict glycemic control. Clearly, it would be desirable to prevent, impede, or reverse the disrupting and often life-threatening manifestations of peripheral neuropathy by stimulating growth or regeneration of peripheral nerve axons.

Conditions

• Painful Diabetic Neuropathy
• Diabetic Neuropathy, Painful

Interventions

Type	Name	Description
BIOLOGICAL	Engensis (VM202)	gene therapy
OTHER	placebo

Timeline

• Start date: 2016-04-01
• Primary completion: 2019-04-01
• Completion: 2019-04-01
• First posted: 2015-04-28
• Last updated: 2025-10-09
• Results posted: 2022-08-22

Locations

25 sites across 1 country: United States