At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 106 enrolled
Drug / intervention
Engensis +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A 6-Month Extension Study Following Protocol VMDN-003-2 - An Adaptive, Phase 3, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess Engensis in Participants With Painful Diabetic Peripheral Neuropathy
In Brief
A Phase 3 clinical trial evaluating Engensis and Placebo for Diabetic Peripheral Neuropathy. Completed, enrolled 106 participants across 16 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Peripheral Neuropathy
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20222023202420252026
First PostedMay 2021
Enrollment StartMay 2021
Primary CompletionSep 2023
Study CompletionJul 2024
TodayJul 2026
First PostedMay 5, 2021
Enrollment StartMay 17, 2021
Primary CompletionSep 14, 2023
Study CompletionJul 23, 2024
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 5.2 years ago
Interventions
Engensisbiological
Injections with Engensis in study VMDN-003-2
Placeboother
Injections with Placebo in study VMDN-003-2