Extension of Phase 3 Gene Therapy for Painful Diabetic Neuropathy
NCT ID: NCT04055090
Last Updated: 2025-10-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
101 participants
INTERVENTIONAL
2019-02-04
2019-07-24
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Subjects who received Engensis (VM202)
VM202, Engensis
Long-Term Follow-Up of Patients who Received Engensis (VM202)
No study drug is administered in this study. Patients who received Engensis (VM202) in the previous trial (VMDN-003) will remain blinded and were evaluated in this trial for long-term safety and efficacy.
Subjects who received Placebo
Placebo, vehicle
Long-Term Follow-Up of Patients who Received Placebo
No study drug is administered in this study. Patients who received Placebo in the previous trial (VMDN-003) will remain blinded and were evaluated in this trial for long-term safety and efficacy.
Interventions
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Long-Term Follow-Up of Patients who Received Engensis (VM202)
No study drug is administered in this study. Patients who received Engensis (VM202) in the previous trial (VMDN-003) will remain blinded and were evaluated in this trial for long-term safety and efficacy.
Long-Term Follow-Up of Patients who Received Placebo
No study drug is administered in this study. Patients who received Placebo in the previous trial (VMDN-003) will remain blinded and were evaluated in this trial for long-term safety and efficacy.
Eligibility Criteria
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Inclusion Criteria
2. Received all intramuscular injections of study drug on Days 0, 14, 90, and 104 in the VMDN-003 study
3. 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
2. Were unable or unwilling to give informed consent
18 Years
75 Years
ALL
No
Sponsors
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Helixmith Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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John A. Kessler, MD
Role: PRINCIPAL_INVESTIGATOR
Northwestern University
Locations
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Arizona Research Center
Phoenix, Arizona, United States
Clinical Trials, Inc.
Little Rock, Arkansas, United States
Northern California Research
Sacramento, California, United States
Center for Clinical Research
San Francisco, California, United States
Neurological Research Institute
Santa Monica, California, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, United States
Innovative Research of West Florida
Clearwater, Florida, United States
University of Florida McKnight Brain Institute
Gainesville, Florida, United States
Clinical Research of West Florida
Tampa, Florida, United States
The Brigham and Women's Hospital
Boston, Massachusetts, United States
Raleigh Neurology Associates, P.A.
Raleigh, North Carolina, United States
Nerve and Muscle Center of Texas
Houston, Texas, United States
EVMS (Eastern Virginia Medical School)
Norfolk, Virginia, United States
Rainier Clinical Research Center, Inc.
Renton, Washington, 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-003b
Identifier Type: -
Identifier Source: org_study_id
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