At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 12 enrolled
Drug / intervention
VM202biological
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 Phase I/II, Open Label, Dose-Escalation Study to Assess the Safety and Tolerability of Engensis (VM202) in Patients With Painful Diabetic Peripheral Neuropathy
In Brief
A Phase 2 clinical trial evaluating VM202 for Painful Diabetic Peripheral Neuropathy. Completed, enrolled 12 participants across 2 sites.
Detailed Summary
The purpose of this open label, Phase I/II, dose-escalation, 3-cohort, multicenter, 12-month study, is to assess the safety and tolerability of injecting Engensis (VM202) in the leg muscle in patients with painful diabetic peripheral neuropathy (DPN). The study will also assess the potential of VM202 to reduce the pain associated with diabetic peripheral neuropathy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPainful Diabetic Peripheral Neuropathy
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 2009
Enrollment StartFeb 2010
Primary CompletionApr 2011
Study CompletionApr 2012
TodayJul 2026
First PostedOct 27, 2009
Enrollment StartFeb 1, 2010
Primary CompletionApr 1, 2011
Study CompletionApr 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 16.7 years ago
Interventions
VM202biological
Intramuscular injections in the calf on Day 0 and Day 14.