Status:
COMPLETED
Extension of Phase 3 Gene Therapy for Painful Diabetic Neuropathy
Lead Sponsor:
Helixmith Co., Ltd.
Conditions:
Painful Diabetic Neuropathy
Diabetic Neuropathy, Painful
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to explore the overall safety profile and durability of efficacy of Engensis (VM202) in painful diabetic peripheral neuropathy. All subjects still in follow-up for the VM...
Detailed Description
In the phase III VMDN-003 study, subjects received 2 treatments of either Engensis (VM202) or placebo administered as intramuscular injections into bilateral calves on Days 0 and 14, and Days 90 and 1...
Eligibility Criteria
Inclusion
- Were randomized and dosed in the VMDN-003 study
- Received all intramuscular injections of study drug on Days 0, 14, 90, and 104 in the VMDN-003 study
- Were in follow-up for the VMDN-003 study or had completed Day 270 within the last 90 days prior to signing consent
Exclusion
- Were using an investigational drug or treatment
- Were unable or unwilling to give informed consent
Key Trial Info
Start Date :
February 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 24 2019
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT04055090
Start Date
February 4 2019
End Date
July 24 2019
Last Update
October 9 2025
Active Locations (14)
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1
Arizona Research Center
Phoenix, Arizona, United States, 85023
2
Clinical Trials, Inc.
Little Rock, Arkansas, United States, 72205
3
Northern California Research
Sacramento, California, United States, 95821
4
Center for Clinical Research
San Francisco, California, United States, 94115