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Trial record 1 of 1 for:    NCT04055090
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Extension of Phase 3 Gene Therapy for Painful Diabetic Neuropathy

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ClinicalTrials.gov Identifier: NCT04055090
Recruitment Status : Active, not recruiting
First Posted : August 13, 2019
Last Update Posted : April 2, 2020
Sponsor:
Information provided by (Responsible Party):
Helixmith Co., Ltd.

Study Description
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Brief Summary:

The purpose of this study is explore the overall safety profile and durability of efficacy of VM202 in painful diabetic peripheral neuropathy.

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.


Condition or disease Intervention/treatment
Painful Diabetic Neuropathy Diabetic Neuropathy, Painful Genetic: Long-Term Follow-Up of Patients who Received VM202 Drug: Long-Term Follow-Up of Patients who Received Placebo

Detailed Description:
In the phase III VMDN-003 study, subjects received 2 treatments of either VM202 or placebo administered as intramuscular (IM) injections into bilateral calves on Days 0 and 14, and Days 90 and 104. Primary efficacy was evaluated 90 days following the first injection. The growth potential for HGF make long-term follow-up important both for safety and efficacy: in order for VM202 to be a candidate for chronic treatment of PDPN, it must be demonstrated not to induce unexpected adverse events with repeated dosing; and the potential for reversal or stabilization of diabetic neuropathy using only one or two treatments of VM202 may make it especially attractive compared to current treatments which must be taken daily for the duration of the disease. A safety extension to the VMDN-003 study is therefore warranted.
Study Design
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Study Type : Observational
Actual Enrollment : 101 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Long-term, Prospective, Non-interventional, Safety Extension of a Phase III, Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Safety and Efficacy of VM202 in Subjects With Painful Diabetic Peripheral Neuropathy
Actual Study Start Date : January 30, 2019
Actual Primary Completion Date : July 14, 2019
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Subjects who received VM202 Genetic: Long-Term Follow-Up of Patients who Received VM202
No study drug is administered in this study. Patients who received VM202 in a previous trial will be evaluated in this trial for long-term safety and efficacy.
Subjects who received Placebo Drug: Long-Term Follow-Up of Patients who Received Placebo
No study drug is administered in this study. Patients who received Placebo in a previous trial will be evaluated in this trial for long-term safety and efficacy.


Outcome Measures
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Primary Outcome Measures :
  1. the difference in long-term safety [ Time Frame: Baseline through Day 365 follow up ]
    defined as occurrence of adverse events - observed between subjects receiving VM202 versus subjects receiving placebo in the VMDN-003 study


Secondary Outcome Measures :
  1. The change in the average 24-hour pain score from baseline to the Day 365 follow-up [ Time Frame: baseline to the Day 365 follow-up ]
    The change in the average 24-hour pain score from baseline to the Day 365 follow-up from the Daily Pain and Sleep Interference Diary

  2. The change in the average 24-hour pain score from Day 270 to the Day 365 follow-up [ Time Frame: Day 270 to the Day 365 follow-up ]
    The change in the average 24-hour pain score from Day 270 to the Day 365 follow-up from the Daily Pain and Sleep Interference Diary;

  3. Patient's Global Impression of Change (PGIC) at the Day 365 follow-up [ Time Frame: At the Day 365 follow-up ]
    The patient's global impression of change


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects currently in follow-up in the VMDN-003 study or having completed Day 270 within the last 90 days will be invited to enroll in this safety extension study
Criteria

Inclusion Criteria:

  1. Subjects randomized and dosed in the VMDN-003 study;
  2. Having received all intramuscular injections of study drug on Days 0, 14, 90, and 104 in the VMDN-003 study;
  3. Currently in follow-up for the VMDN-003 study or having completed Day 270 within the last 90 days prior to signing consent.

Exclusion Criteria:

  1. Current use of an investigational drug or treatment; and
  2. Unable or unwilling to give informed consent.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04055090


Locations
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Sponsors and Collaborators
Helixmith Co., Ltd.
Investigators
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Principal Investigator: John A. Kessler, MD Northwestern University
More Information
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Responsible Party: Helixmith Co., Ltd.
ClinicalTrials.gov Identifier: NCT04055090    
Other Study ID Numbers: VMDN-003b
First Posted: August 13, 2019    Key Record Dates
Last Update Posted: April 2, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Keywords provided by Helixmith Co., Ltd.:
diabetic
neuropathy
shooting pain
burning pain
 pins and needles pain
foot pain
ViroMed
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Diabetic Neuropathies
Pain
Neuromuscular Diseases
Nervous System Diseases
 Neurologic Manifestations
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases