At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 162 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.
An Adaptive, Phase 3, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Safety and Efficacy of Engensis in Participants With Painful Diabetic Peripheral Neuropathy
In Brief
A Phase 3 clinical trial evaluating Engensis and Placebo for Diabetic Neuropathy, Painful. Completed, enrolled 162 participants across 16 sites.
Detailed Summary
The purpose of this study is to evaluate the efficacy and safety of intramuscular administration of Engensis on pain in participants with painful diabetic peripheral neuropathy in the feet and lower legs, as compared to Placebo, as a second Phase 3, well controlled study, sufficient in supporting the efficacy and safety of Engensis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Neuropathy, Painful
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
202120222023202420252026
First PostedJul 2020
Enrollment StartNov 2020
Primary CompletionMar 2023
Study CompletionJul 2024
TodayJul 2026
First PostedJul 14, 2020
Enrollment StartNov 20, 2020
Primary CompletionMar 24, 2023
Study CompletionJul 31, 2024
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 6.0 years ago
Interventions
Engensisbiological
Intramuscular injections
Placeboother
Intramuscular injections