Phase 3
N=106
A 6-Month Extension Study of VMDN-003-2 to Assess Engensis in Participants With Painful Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathy
Bottom Line
View on ClinicalTrials.gov: NCT04873232 ↗Enrolled (actual)
106
Serious AEs
8.5%
Results posted
Jan 2025
Primary outcome: Primary: To Evaluate the Efficacy of Intramuscular Administration of Engensis on Reducing Pain in Participants With Painful Diabetic Peripheral Neuropathy in the Feet and Lower Legs as Compared to Placebo — -2.27; -2.62; -2.53; -2.78 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Engensis (Biological); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Helixmith Co., Ltd.
- Primary completion
- Sep 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY To Evaluate the Efficacy of Intramuscular Administration of Engensis on Reducing Pain in Participants With Painful Diabetic Peripheral Neuropathy in the Feet and Lower Legs as Compared to Placebo |
-2.27; -2.62; -2.53; -2.78 | — |
| SECONDARY To Evaluate the Efficacy of IM Administration of Engensis on the Worst Pain in Participants With Painful Diabetic Peripheral Neuropathy in the Feet and Lower Legs as Compared to Placebo |
-2.50; -2.94; -2.65; -3.19 | — |
| SECONDARY To Evaluate the Safety of IM Administration of Engensis in the Number of Participants With Painful DPN in the Feet and Lower Legs as Compared to Placebo |
16; 22 | — |
| SECONDARY To Evaluate the Efficacy of Administration of Engensis on Reducing Pain in Participants With Painful Diabetic Peripheral Neuropathy in the Feet and Lower Legs |
17; 27; 16; 27 | — |
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 Phase 3 Study.
Eligibility Criteria
Inclusion Criteria
- Completed study VMDN-003-2 and consent to enroll in study VMDN-003-2b
Exclusion Criteria
- None
Data sourced from ClinicalTrials.gov (NCT04873232). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.