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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04873232
Other study ID # VMDN-003-2b
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date May 17, 2021
Est. completion date December 2023

Study information

Verified date November 2022
Source Helixmith Co., Ltd.
Contact Thu Doan
Phone 858-815-1311
Email Thu.Doan@Helixmith.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To evaluate the durability of efficacy and long-term safety of intramuscular (IM) administration of Engensis or Placebo that was administered in the double-blind, randomized, VMDN-003-2 Placebo-controlled Phase 3 Study.


Description:

The purpose of this 6-month extension study (VMDN-003-2b) is to evaluate the durability of efficacy and long-term safety of intramuscular (IM) administration of Engensis or Placebo that was administered in the double-blind, randomized, VMDN-003-2 Placebo-controlled Phase 3 Study. No treatments will be administered in this VMDN-003-2b extension study. The combined overall duration of the VMDN-003-2 and VMDN-003-2b studies will be 12 months. 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 (ADPS) of the full Brief Pain Inventory for Diabetic Peripheral Neuropathy (BPI-DPN), Bedside Sensory Testing (BST), physical examinations, laboratory assessments, vital signs, treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (TESAEs), and adverse events of special interest (AESIs).


Recruitment information / eligibility

Status Recruiting
Enrollment 250
Est. completion date December 2023
Est. primary completion date October 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Completed study VMDN-003-2 and consent to enroll in study VMDN-003-2b Exclusion Criteria: - None

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Engensis
Injections with Engensis in study VMDN-003-2
Other:
Placebo
Injections with Placebo in study VMDN-003-2

Locations

Country Name City State
United States Clinical Research Professionals Chesterfield Missouri
United States Innovative Research of West Florida, Inc. Clearwater Florida
United States Nerve and Muscle Center of Texas Houston Texas
United States Clinical Trials - Little Rock Little Rock Arkansas
United States California Medical Clinic for Headache Los Angeles California
United States Manassas Clinical Research Center Manassas Virginia
United States Futuro Clinical Trials McAllen Texas
United States Eastern Virginia Medical School Norfolk Virginia
United States Gateway Clinical Trials, LLC O'Fallon Illinois
United States Arizona Research Center Phoenix Arizona
United States Health Concepts Rapid City South Dakota
United States Dominion Medical Associates Richmond Virginia
United States Clinical Trials Research - Sacramento Sacramento California
United States Foot & Ankle Center of Illinois Springfield Illinois
United States Richmond Behavioral Associates Staten Island New York
United States ClinPoint Trials LLC Waxahachie Texas

Sponsors (1)

Lead Sponsor Collaborator
Helixmith Co., Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary To evaluate the efficacy of IM administration of Engensis on pain in Participants with painful DPN in the feet and lower legs as compared to Placebo Change in the means of the Average Daily Pain Scores (ADPSs) from the full Brief Pain Inventory for Diabetic Peripheral Neuropathy (BPI-DPN). Maximum score = 10, minimum score = 1, higher score is a worse outcome. From the 7 days prior to the Day 0 Visit (Study VMDN-003-2) to 7 days prior to the Day 365 Visit
Secondary To evaluate the efficacy of IM administration of Engensis on the worst pain in Participants with painful DPN in the feet and lower legs as compared to Placebo Change in the means of the Worst Pain scores from the full Brief Pain Inventory for Diabetic Peripheral Neuropathy (BPI-DPN). Maximum score = 10, minimum score = 1, higher score is a worse outcome. From the 7 days prior to the Day 0 Visit (Study VMDN-003-2) to the 7 days prior to the Day 365 Visit
Secondary To evaluate the efficacy of IM administration of Engensis on reducing pain in Participants with painful DPN in the feet and lower legs Proportion of Responders (>=50% reduction in the ADPSs from the full BPI-DPN) From the 7 days prior to the Day 0 Visit (Study VMDN-003-2) to the 7 days prior to the Day 270 Visit and the 7 days prior to the Day 365 Visit
Secondary To evaluate the safety of IM administration of Engensis in Participants with painful DPN in the feet and lower legs Incidence of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (TESAEs), and clinically significant laboratory values Day 0 to Day 365
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