Phase 3 Gene Therapy for Painful Diabetic Neuropathy

  • STATUS
    Not Recruiting
  • participants needed
    477
  • sponsor
    ViroMed Co., Ltd. dba VM BioPharma
Updated on 23 January 2021
diabetes
insulin
duloxetine
gabapentin
pregabalin
hemoglobin a1c
glycosylated hemoglobin
medication regimen
peripheral neuropathy
diabetic peripheral neuropathy
diabetic neuropathy
painful diabetic neuropathy
lower extremity pain
no new symptoms
neurontin
lyrica
cymbalta

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 neuropathy.

A total of 477 subjects will be randomized in a 2:1 ratio to one of two treatment groups:

Treatment - VM202 - 318 subjects Control - Placebo (VM202 vehicle) - 159 subjects

Randomization will be stratified by current use of gabapentin and/or pregabalin.

Description

Peripheral neuropathy is a serious complication of diabetes. This form of neuropathy carries a high risk of pain, trophic changes and autonomic dysfunction. Treatment of diabetic peripheral neuropathy (DPN) is 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. The results from previous studies suggest that VM202 provides the same magnitude of pain relief as reported with pregabalin or gabapentin.

Details
Condition DIABETIC NEUROPATHY
Treatment Placebo, VM202
Clinical Study IdentifierNCT02427464
SponsorViroMed Co., Ltd. dba VM BioPharma
Last Modified on23 January 2021

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