A 6-Month Extension Study of VMDN-003-2 to Assess Engensis in Participants With Painful Diabetic Peripheral Neuropathy
NCT ID: NCT04873232
Last Updated: 2025-10-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
106 participants
INTERVENTIONAL
2021-05-17
2024-07-23
Brief Summary
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Detailed Description
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Participants will be enrolled in the VMDN-003-2b study at completion of the Day 180 Visit of Study VMDN-003-2. Participants will continue to be identified by the same Participant number and the same treatment group (Engensis or Placebo) assigned by randomization in Study VMDN-003-2. No study drug or treatment will be administered in this VMDN-003-2b extension study. The double-blind treatment assignment from the prior study will be maintained for Investigators and Participants during this extension study.
This extension study will assess the durability of efficacy and long-term safety of Engensis compared to Placebo as measured by changes in Average Daily Pain Score of the full Brief Pain Inventory for Diabetic Peripheral Neuropathy, Bedside sensory testing, physical examinations, laboratory assessments, vital signs, treatment-emergent adverse events, treatment-emergent serious adverse events, and adverse events of special interest.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Engensis
Patients who have received Engensis in protocol VMDN-003-2
Engensis
Injections with Engensis in study VMDN-003-2
Placebo
Patients who have received Placebo in protocol VMDN-003-2
Placebo
Injections with Placebo in study VMDN-003-2
Interventions
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Engensis
Injections with Engensis in study VMDN-003-2
Placebo
Injections with Placebo in study VMDN-003-2
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Helixmith Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Arizona Research Center
Phoenix, Arizona, United States
Clinical Trials - Little Rock
Little Rock, Arkansas, United States
California Medical Clinic for Headache
Los Angeles, California, United States
Clinical Trials Research - Sacramento
Sacramento, California, United States
Innovative Research of West Florida, Inc.
Clearwater, Florida, United States
Gateway Clinical Trials, LLC
O'Fallon, Illinois, United States
Foot & Ankle Center of Illinois
Springfield, Illinois, United States
Clinical Research Professionals
Chesterfield, Missouri, United States
Richmond Behavioral Associates
Staten Island, New York, United States
Health Concepts
Rapid City, South Dakota, United States
Nerve and Muscle Center of Texas
Houston, Texas, United States
Futuro Clinical Trials
McAllen, Texas, United States
ClinPoint Trials LLC
Waxahachie, Texas, United States
Manassas Clinical Research Center
Manassas, Virginia, United States
Eastern Virginia Medical School
Norfolk, Virginia, United States
Dominion Medical Associates
Richmond, Virginia, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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VMDN-003-2b
Identifier Type: -
Identifier Source: org_study_id
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