Extension of Phase 3 Gene Therapy for Painful Diabetic Neuropathy

Clinical Trial ID: NCT04055090

Description

The purpose of this study is explore the overall safety profile and durability of efficacy of VM202 in painful diabetic peripheral neuropathy. All subjects still in follow-up for the VMDN-003 study or who have completed the Day 270 visit within the prior 90 days will be approached to enroll in the long-term safety extension study.

In the phase III VMDN-003 study, subjects received 2 treatments of either VM202 or placebo administered as intramuscular (IM) injections into bilateral calves on Days 0 and 14, and Days 90 and 104. Primary efficacy was evaluated 90 days following the first injection. The growth potential for HGF make long-term follow-up important both for safety and efficacy: in order for VM202 to be a candidate for chronic treatment of PDPN, it must be demonstrated not to induce unexpected adverse events with repeated dosing; and the potential for reversal or stabilization of diabetic neuropathy using only one or two treatments of VM202 may make it especially attractive compared to current treatments which must be taken daily for the duration of the disease. A safety extension to the VMDN-003 study is therefore warranted.


Criteria

Inclusion Criteria: 1. Subjects randomized and dosed in the VMDN-003 study; 2. Having received all intramuscular injections of study drug on Days 0, 14, 90, and 104 in the VMDN-003 study; 3. Currently in follow-up for the VMDN-003 study or having completed Day 270 within the last 90 days prior to signing consent. Exclusion Criteria: 1. Current use of an investigational drug or treatment; and 2. Unable or unwilling to give informed consent.

  • Start Date

    2019-01-30

  • Last Updated

    2019-08-12

  • Sponsor

    Helixmith Co., Ltd.

  • Condition Name

    Diabetic Neuropathy, Painful

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