Status:
COMPLETED
A 6-Month Extension Study of VMDN-003-2 to Assess Engensis in Participants With Painful Diabetic Peripheral Neuropathy
Lead Sponsor:
Helixmith Co., Ltd.
Conditions:
Diabetic Peripheral Neuropathy
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
To evaluate the durability of efficacy and long-term safety of intramuscular administration of Engensis or Placebo that was administered in the double-blind, randomized, VMDN-003-2 Placebo-controlled ...
Detailed Description
The purpose of this 6-month extension study (VMDN-003-2b) is to evaluate the durability of efficacy and long-term safety of intramuscular administration of Engensis or Placebo that was administered in...
Eligibility Criteria
Inclusion
- Completed study VMDN-003-2 and consent to enroll in study VMDN-003-2b
Exclusion
- None
Key Trial Info
Start Date :
May 17 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 23 2024
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT04873232
Start Date
May 17 2021
End Date
July 23 2024
Last Update
October 9 2025
Active Locations (16)
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1
Arizona Research Center
Phoenix, Arizona, United States, 85053
2
Clinical Trials - Little Rock
Little Rock, Arkansas, United States, 72205
3
California Medical Clinic for Headache
Los Angeles, California, United States, 90048
4
Clinical Trials Research - Sacramento
Sacramento, California, United States, 95821