Phase 3
Completed N=101
Extension of Phase 3 Gene Therapy for Painful Diabetic Neuropathy
Painful Diabetic Neuropathy · Diabetic Neuropathy, Painful
Source: ClinicalTrials.gov NCT04055090 ↗
Enrolled (actual)
101
Serious AEs
3.0%
Results posted
Mar 2023
Primary outcomePrimary: Long-term Safety for Engensis Versus Placebo — 10; 8; 1; 2 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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 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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Long-term Safety for Engensis Versus Placebo |
10; 8; 1; 2 | — |
| SECONDARY The Change in the Average 24-hour Pain Score From Baseline (Day 0 of Study VMDN-003) to Day 365 for Engensis Versus Placebo |
-2.32; -1.49 | 0.0460 sig |
| SECONDARY Change in the Average 24-hour Pain Score From Day 270 to Day 365 for Engensis Versus Placebo |
0.26; 0.29 | — |
| SECONDARY Patient's Global Impression of Change at the Day 365 Visit for Engensis Versus Placebo |
31; 14; 31; 20; 1; 2 | 0.2190 |
| SECONDARY Subgroup Analysis of the Change in the Average 24-hour Pain Score From Baseline (Day 0 of Study VMDN-003) to Day 365 for Engensis Versus Placebo for Subjects Without Gabapentin and/or Pregabalin Use at Baseline |
-2.30; -0.82 | 0.0155 sig |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- Were using an investigational drug or treatment
- Were unable or unwilling to give informed consent
Data sourced from ClinicalTrials.gov (NCT04055090). 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. Informational only — not medical advice.